From:
S 47F
To:
AERP
Subject:
Nexgard - 17AU000440
Date:
Wednesday, 16 August 2017 10:25:19 AM
Attachments:
image001.jpg
17AU000440_Nexgard.pdf
Hi S 47F
Please find attached a serious suspected AE report following administration of Nexgard Chewables for Dogs.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000440
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Owner
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
3-Aug-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 1
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Staffordshire Terrier
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
22
1.5 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67940
NEXGARD CHEWABLES FOR DOGS 10.1-25 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 68 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: AAA116917
E xp iry d a te :
S to ra g e d e ta ils:
28-Feb-2020
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
3-Aug-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 15-Aug-2017 at 19:37
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000440
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
3-Aug-2017
D u ra tio n o f re a c tio n :
1 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the owner, Diesel, a male, intact, 1.5 year old, Staffordshire Terrier, weighing
22kg, received one dosage form of NEXGARD CHEWABLES FOR DOGS 10.1-25KG (68MG Afoxolaner, BA:
AAA1169/17, EX: 02/20), administered orally by the owner for flea and tick control on the 3rd of
August 2017 at 9am. Approximately 5 hours later (at 1:20pm), the owner came home and saw that the
dog had seizured, was disorientated, banging into things and was drooling/foaming from the mouth.
The dog received veterinary attention and was noted to have constricted pupils which were not
responsive to light, pyrexia and congested mms. He was treated for toxins [valium (diazepam)
4.4ml IV, phenobarb 2 x 30mg PO, oxygen, IV fluids, anaesthesia and gastric lavage]. Full bloods
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
Valium (diazepam) 4.4ml IV, phenobarb 2 x 30mg PO, oxygen, IV fluids, anaesthesia and gastric
lavage, further valium (diazepam), dexamthasone, phenobarb IV.
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
1
0
0
0
0
0
D a te w h e n :
4-Aug-2017
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s):
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
While seizures have very rarely been reported temporal to use of isoxazoline class products and
the chronology is consistent with the pharmacological profile of the product, visual impairment
and circling are not expected. No necropsy was conducted and other causes remain plausible. Case
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 15-Aug-2017 at 19:37
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000440
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
7. R EACT ION D AT A (continued)
Adverse Events
including CK (to rule out snake bite) were unremarkable. He initially looked better after this
treatment, but a few hours later was agitated again with abnormal mentation, so was given
diazepam again. He was transferred to a referal hospital for overnight care. They also noted
absent menace reflexes, R circling. Given dexamethasone and diazepam. 7am 4th Aug he had another
seizure which was treated with phenobarb IV and he settled. 9am minimally responsive to
environment. Owner elected euthanasia on the 4th of August 2017. This is the extent of the
information available., (Outcome : Death (All Causes))
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
is classified O1 - inconclusive.
Version : 15-Aug-2017 at 19:37
Aerp Report S-17-52692-V
Page 1 of 4
Report Generated Mon Aug 21 12:12:54 EST 2017
Adverse Experience Report S-17-52692-V
General Details
Report
S-17-52692-V
Type
Veterinary
Category
Standard
Number
Date
Category
Standard
Scheme
Voluntary
16/08/2017
Received
Report
2017
Priority
Low
Status
Initial
Year
Web
Country
Australia
Reference
Comments 4078
Registrant Details
Registrant
Registrant
4078
Reference
Received
Products
Product 1
Product
Expiry
Chemical VET * SMALL ANIMALS -
67940
30/06/2018
Number
Date
Class
EXTERNAL
Product
NEXGARD CHEWABLES FOR DOGS 10.1-25 KG
Name
Registrant MERIAL AUSTRALIA PTY LTD
Active(s)
AFOXOLANER
Comments
Animals
Animal 1
Species
Canine
Breed
Sex
Male
Production
Physiological Not applicable
Health
Type
Status
(male)
Status
Min Age
Max Age
Avg Age
1years
Min
Avg
Max Weight
24kg
Weight
Weight
No
No Treated 1
No Affected
1
1
Destroyed
Crop
Crop/Situation
Sub
Crop/Situation
Plant Type
Situation
Treated
Affected
Growth State
Area
Area
Application
Type of
Applicator
Pesticides
Application
Required
Mixed
file:///C:/Users/S 47F
/AppData/Local/Temp/52692150328157465024969227329194... 21/08/2017
Aerp Report S-17-52692-V
Page 2 of 4
No
How Mixed
Frequency
Applications
Pressure
Used
Height Above
Crop
Protective
Measures
Precautions
Equipment
Last
Calibrated
Last Cleaned
How Cleaned
Nozzle Types
Droplet Size
Previous
Products
Conditions
Prior To
Treatment
At
Treatment
After
Treatment
Incident
After giving this to my dog within 4 hours my dog had seizured several
times. My dog was taken to the vet where he continued to seizure, was
Events
monitored overnight and I was told that the seizured had caused some
Following
brain damage which would cost $5,000-$10,000 to have him seen by a
Treatment
brain specialist with no guarantee that there would be a chance of him
returning to his normal self.
Event
Euthanased
Outcome
Professional
If Vet reports are needed I can get these.
Report
Pathology
Results
The product is highly recoomended by vets and pet stores and no one
mentioned the side effects that this product can cause. The Box that you
APVMA
purchase has no information regarding side effects and what it can cause
Comments
and neither does its pamplet that comes in the box, However if you go to
the NexGard website it lists a very long list of side effects which if i had
read I would not have given to my dog.
Safety/Efficacy
Citations
Presenting Signs
file:///C:/Users/S 47F
/AppData/Local/Temp/52692150328157465024969227329194... 21/08/2017
Aerp Report S-17-52692-V
Page 3 of 4
Safety/Efficacy
Citations
Date of
Presenting
03/08/2017
Signs
Presenting
Signs
Treatment
Administered
Route of
Initial
Owner
By
Exposure
Treatment Date
Final
Treatment
Exposure/Onset
Treatment
4hours
Time
Interval
Date
Treatment
Dose
Frequency of
Administration
Duration of
Adverse
continuing seizures
Experience
Pest/Purpose
Control of Fleas
Used
According to Yes
Label
Stored
According to Yes
Label
Date of
Outcome
Classification
Registrant Assessment
Previous
Relevant Medical
Previous Side
Product
History
Effects
Exposure
Side Effects
Side Effects Stop
Registrant
Reappear on
After Cease
Classification
Re-Use
Proffesional
Assessment
Registrant
Comments
Registrant
Assessment
Registrant Action
APVMA Assessment
APVMA
Classification
Recommendation
Classification
Date
Date
APVMA
Comments
Agency
Comments
file:///C:/Users/S 47F
/AppData/Local/Temp/52692150328157465024969227329194... 21/08/2017
Aerp Report S-17-52692-V
Page 4 of 4
APVMA
Recommendation
Algorithm Assessment
Product
Candidates
Overdose
Timing
Dechallenge
Rechallenge
Contacts
Contact 1 (Other)
Name
AF
Employer
Phone
( ) -
Fax
( ) -
Mobile
Email
Address
Contact 2 (Other)
Name
EC
Employer
Phone
( ) -
Fax
( ) -
Mobile
Email
Address
Contact 3 (Owner)
S 47F
Name
Employer
Phone
S 47F
Fax
( ) -
Mobile
Email
S 47F
Address S 47F
Contact 4 (Registrant)
Merial
S 47F
Name
Employer Australia Pty
Phone
S 47F
Ltd
Fax
( ) -
Mobile
S 47F
Email
S 47F
Address Level 1 78 Waterloo Road North Ryde NSW 2113
Files
No Files
Adverse Experience Report S-17-52692-V
file:///C:/Users/S 47F
/AppData/Local/Temp/52692150328157465024969227329194... 21/08/2017
From:
S 47F
To:
AERP
Subject:
Re: [APVMA-securemail] Adverse Experience Report on Nexgard - S-17-52692-V [DLM=Sensitive]
Date:
Friday, 6 October 2017 3:25:28 PM
Attachments:
17AU000677_Nexgard.pdf
Hi S 47F
Thank you for sending this report through, it was not reported directly to us. Very sad
outcome for the dog and the pet owner.
We have created a PV works case for this report and assessed it - see attached. If you do
manage to obtain the dog's medical history and are able to share it with us, it would be
helpful to include it in the PV works case.
Kind regards
S 47F
----- Original Message -----
From: AERP
Date: Thu, 5 Oct 2017 05:45:23 +0000
To: S 47F
Subject: [APVMA-securemail] Adverse Experience Report on Nexgard - S-
17-52692-V [DLM=Sensitive]
Sensitive
Good afternoon S 47F
The APVMA have received the following report for Nexgard Chewables for Dogs
10.1-25kg, in which 1 dog showed adverse signs. This was reported to us by the
dog’s owner from S 47F
.
Please would you kindly check your systems for a match.
We would appreciate classification and comment by Friday, 10 November 2017.
We propose a classification of Possible.
With thanks,
S 47F
Administration Officer
Australian Pesticides and Veterinary Medicines Authority (APVMA)
246 Beardy Street, Armidale, NSW, 2350
Report Generated Thu Oct 05 16:12:46 EST 2017
Adverse Experience Report S-17-52692-V
General Details
Report
S-17-52692-V
Type
Veterinary
Category
Standard
Number
Date
Category
Standard
Scheme
Voluntary
16/08/2017
Received
Report
2017
Priority
Low
Status
Initial
Year
Web
Country
Australia
Reference
Comments 4078
Registrant Details
Registrant
Registrant
Web ref 4078
Reference
Received
Products
Product 1
Product
Expiry
Chemical VET * SMALL ANIMALS -
67940
30/06/2018
Number
Date
Class
EXTERNAL
Product
NEXGARD CHEWABLES FOR DOGS 10.1-25 KG
Name
Registrant MERIAL AUSTRALIA PTY LTD
Active(s)
AFOXOLANER
Comments
Animals
Animal 1
Species
Canine
Breed
Sex
Male
Production
Physiological Not applicable
Health
Companion
Type
Status
(male)
Status
Min Age
Max Age
Avg Age
1years
Min
Avg
Max Weight
24kg
Weight
Weight
No
No
1
No Affected 1
1
Treated
Destroyed
Incident
After giving this to my dog within 4 hours my dog had seizured several
times. My dog was taken to the vet where he continued to seizure, was
Events
monitored overnight and I was told that the seizured had caused some
Following
brain damage which would cost $5,000-$10,000 to have him seen by a
Treatment
brain specialist with no guarantee that there would be a chance of him
returning to his normal self.
Event
Euthanased
Outcome
Professional
If Vet reports are needed I can get these.
Report
Pathology
Results
The product is highly recoomended by vets and pet stores and no one
mentioned the side effects that this product can cause. The Box that you
APVMA
purchase has no information regarding side effects and what it can cause
Comments
and neither does its pamplet that comes in the box, However if you go to
the NexGard website it lists a very long list of side effects which if i had
read I would not have given to my dog.
Safety/Efficacy
Citations
Presenting
Signs
Safety/Efficacy
Citations
Date of
Presenting
03/08/2017
Signs
Presenting
Signs
Treatment
Administered
Route of
Initial
Owner
By
Exposure
Treatment Date
Final
Treatment
Exposure/Onset
Treatment
4hours
Time
Interval
Date
Treatment
Dose
Frequency of
Administration
Duration of
Adverse
continuing seizures
Experience
Pest/Purpose
Control of Fleas
Used
According to
Yes
Label
Stored
According to
Yes
Label
Date of
Outcome
Adverse Experience Report S-17-52692-V
Sensitive
IMPORTANT:
This email message and any attached files may be subject to restrictions on
use and disclosure under the
Agricultural and Veterinary Chemicals Code Act
1994 and may so contain information that is confidential, and/or subject to
legal professional privilege.
If you are not the intended recipient, you must not use, copy, disseminate,
forward, retain or reproduce this email. If you received this email in error,
please immediately notify the sender by return email or contact the APVMA
on +61-2-6210 4701 (9 am-5 pm AEST/AEDT) and please delete all copies of
this email and any attachments.
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000677
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Regulatory authority
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
4-Oct-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r: Regulatory authority
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 1
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Canine (unknown)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
24
1 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67940
NEXGARD CHEWABLES FOR DOGS 10.1-25 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 68 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
Unknown
3-Aug-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 5-Oct-2017 at 21:04
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000677
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
3-Aug-2017
D u ra tio n o f re a c tio n :
1 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
Adverse Events
As reported by the officer of the regulatory authority, a 1 yr old, 24 kg, male dog received 1
dosage form PO of NEXGARD CHEWABLES FOR DOGS 10.1 -25 kg (68mg Afoxolaner, unknown batch and
expiry) for flea and tick control administered by the owner on the 3rd of August 2017. 'Within 4
hours the dog had seizured several times'. Vet attention was sought where he continued to
seizure. The dog was monitored overnight and the owner was informed ‘the seizures had caused some
brain damage’. The owner declined neurology referral. The dog was euthanized on an unknown date
estimated 4th August 2017. This is the extent of information available., (Outcome : Euthanasia)
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
1
0
0
0
0
0
D a te w h e n :
4-Aug-2017*
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Unknown
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e : Unknown
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
P o ssib le
R e a so n fo r c la ssific a tio n :
See continuation page
Although seizures have very rarely been reported temporal to use of isoxazoline class products,
brain damage is not typical of an adverse reaction related to NEXGARD at recommended dosages. In
the absence of further information, other causes remain plausible. Based on seizures, case
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
* approximate
Version : 5-Oct-2017 at 21:04
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000677
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
assessed B.
Version : 5-Oct-2017 at 21:04
From:
S 47F
To:
AERP
Subject:
Human exposure - Nexgard 17AU000458
Date:
Wednesday, 16 August 2017 10:29:17 AM
Attachments:
image001.jpg
17AU000458_Nexgard_human exposure.pdf
Hi S 47F
Please find attached a non-serious human exposure report following administration of Nexgard Chewables for
Dogs.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000677
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Regulatory authority
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
4-Oct-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r: Regulatory authority
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 1
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Canine (unknown)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
24
1 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67940
NEXGARD CHEWABLES FOR DOGS 10.1-25 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 68 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
Unknown
3-Aug-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 5-Oct-2017 at 21:04
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000677
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
3-Aug-2017
D u ra tio n o f re a c tio n :
1 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
Adverse Events
As reported by the officer of the regulatory authority, a 1 yr old, 24 kg, male dog received 1
dosage form PO of NEXGARD CHEWABLES FOR DOGS 10.1 -25 kg (68mg Afoxolaner, unknown batch and
expiry) for flea and tick control administered by the owner on the 3rd of August 2017. 'Within 4
hours the dog had seizured several times'. Vet attention was sought where he continued to
seizure. The dog was monitored overnight and the owner was informed ‘the seizures had caused some
brain damage’. The owner declined neurology referral. The dog was euthanized on an unknown date
estimated 4th August 2017. This is the extent of information available., (Outcome : Euthanasia)
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
1
0
0
0
0
0
D a te w h e n :
4-Aug-2017*
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Unknown
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e : Unknown
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
P o ssib le
R e a so n fo r c la ssific a tio n :
See continuation page
Although seizures have very rarely been reported temporal to use of isoxazoline class products,
brain damage is not typical of an adverse reaction related to NEXGARD at recommended dosages. In
the absence of further information, other causes remain plausible. Based on seizures, case
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
* approximate
Version : 5-Oct-2017 at 21:04
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000677
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
assessed B.
Version : 5-Oct-2017 at 21:04
From:
S 47F
To:
AERP
Subject:
Nexgard
Date:
Sunday, 13 August 2017 2:46:23 PM
I wish to report a dog flea and tic product called Nexgard.
After we gave our Golden Retriever one Nexgard early March this year
She became very unwell with back leg lameness horrendous seizures
Vision loss hearing loss followed by panting for hours then when she could finally stand with help she was
walking into furniture not knowing where she was or even knowing us her family.
It was the most terrifying experience of our families life.
Having since done a lot of my own research there are hundreds of people that are experiencing exactly the same
thing having used Nexgard.
Our beautiful dog has twice been admitted to emergency animal hospitals. The costs to date have been just over
$6,000 and since my husband and I are retired and on a pension it has cut very deeply into any money we had
put by.
How can this product be allowed to be passed to allow it on a retail market place allow vets who deny
knowledge of these side effects in case they get sued. When hundreds are effected you must have knowledge of
this by now. It needs to be withdrawn from sale.
Nexgard the active ingredient is Afoxolaner a carcinogen that is put into a dogs body by way of a chewy tasty
treat. That is how it is advertised to kill fleas and tics. Once in the dogs blood stream circulating the body if a
flea or tic bites into the dog it is exposed to the carcinogenic and attacks their nervous system and dies in hours.
This carcinogenic is killing dogs. When I appealed for help I was contacted by a scientist studying these
chemicals and she explained to me how this kills some dogs.
If you Google Does Nexgard Kill Dogs by Kimberly Anne you will see lots of things she has written from both
a scientific view that vets just don't understand or know how to deal with it. She has also written in a non
scientific way for everyone to understand.
I ask you to please look and read how these carcinogenic chemicals are causing distressing seizures illness and
symptoms all identical which is all the proof you need to remove this product from sale immediately. Our dog
now has cancer. It is too late to save our family pet but not too late to save hundreds more from Puppies to full
grown dogs.
Kindest regards
S 47F
From:
S 47F
To:
AERP
Subject:
Nexgard - 17AU000472
Date:
Friday, 25 August 2017 3:04:41 PM
Attachments:
image001.jpg
17AU000472.pdf
Hi S 47F
Please find attached a serious suspected AE report following administration of Nexgard Chewables for Dogs.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000472
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Owner
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
14-Aug-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Retriever (Golden)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
32
11.6 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
See continuation page
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67939
NEXGARD CHEWABLES FOR DOGS 25.1-50 KG; Dosage Form: Tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 136 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: BAA117616
E xp iry d a te :
S to ra g e d e ta ils:
30-Apr-2018
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
18-Feb-2017*
23-Apr-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
stilboestrol Unk. Unk. PO-Oral per Unknown, 7 Month(s) 3 Week
(s), (14-Dec-2016 - 3-Aug-
2017)
* approximate
Version : 25-Aug-2017 at 00:13
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000472
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
18-Mar-2017
D u ra tio n o f re a c tio n :
Ongoing
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the owner, Surfe; a 32 kg 11 y 8 months old, female neutered Golden retriever,
received one dosage form NEXGARD CHEWABLES FOR DOGS 25.1 – 50 kg, 136 mg Afoxolaner (batch
BAA117616 and expiry 4/2018) administered orally by the owner for flea and tick control 18 Feb
2017 and 23 April 2017. Dog had seizures on 18 March 2017, 29 March, 12 April, 23 April, and 2
July.The dog was taken to an emergency clinic following the first seizure (18 March). On follow
up veterinary examination 20 March 2017 at regular vet alprazolam 1 mg bid was prescribed. 24
March, she exhibited pacing behaviour and hind limb weakness with tremors especially in LH leg.
Reduced range of movement in both hind legs was also noted. Lovan (fluoxetine) 1.5 tablets sid
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
alprazolam 1mg bid, Lovan (fluoxetine) 1.5 tabs bid, phenobarbitone 100mg bid
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
1
0
0
0
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s):
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
Although seizures have very rarely been reported temporal to product use, the chronology to onset
is inconsistent and can not fully support causality. The other signs are not expected. The first
seizure episode occured almost a month after product administration. Additionally, other causes
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 25-Aug-2017 at 00:13
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000472
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
7. R EACT ION D AT A (continued)
Adverse Events
was prescribed for anxiety. 28 April 2017 the dog was reported to have continuing petit mal type
episodes with clonic spasms. LH trembling was attributed to OA with partial ACL tear. The owner
was also concernd about the dog's polydipsia. It was recommended to stop Nexgard. She was re-
examined 4 July 2017. A seizure had occurred 2 days prior and she was restless. Muscle wastage
was noted in the hindquarters (attributed to arthritis). Phenobarbitone 100mg bid was initiated
for seizure control. She was diagnosed with cancer late July and is on medication to control her
seizures (phenobarbitone) and pain relief (amantadine 20 mg bid, tramadol 100mg bid). The dog has
been on stilboestrol one tablet a week starting 14 Dec 2016. This is the extent of the
information available., (Outcome : Ongoing)
Medical History
on stiboestrol for an unknown condition
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
have not been ruled out, and concurrent medications are a confounding factor. The case is
assessed O1.
Version : 25-Aug-2017 at 00:13
From:
S 47F
To:
AERP
Subject:
17AU000624 Nexgard LOE
Date:
Wednesday, 27 September 2017 11:40:19 AM
Attachments:
image007.jpg
image008.jpg
image009.jpg
image010.jpg
image011.jpg
image012.jpg
17AU000624 nexgard LOE.pdf
Dear S 47F
Please find attached details of a suspected lack of efficacy experience report following
administration of Nexgard Chewables for Dogs 4.1 – 10 kg (APVMA No. 67941).
Please do not hesitate to contact us if anything further is required.
Kind regards,
S 47F
Senior Regulatory Associate
S 47F
Merial is now part of Boehringer Ingelheim
Follow Merial:
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VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000624
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Attending Veterinarian
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
18-Sep-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Terrier (Jack Russell)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
6
10 Month(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67941
NEXGARD CHEWABLES FOR DOGS 4.1-10 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 28.3 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
1-Jan-2017*
1-Sep-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
* approximate
Version : 26-Sep-2017 at 21:35
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000624
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
19-Sep-2017
D u ra tio n o f re a c tio n :
Unknown
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the attending veterinarian, Jewel; a 6 kg, 10 month old, female neutered, Jack
Russell Terrier received NEXGARD CHEWABLES FOR DOGS 4.1-10KG (28.3mg Afoxolaner, unknown batch
and expiry) orally on the 1st of Sept 2017 for tick and flea control by the owner. On the night
of the 18th, the owner found a tick on the right lateral neck (under the collar) and removed it.
No other symptoms were noted at the time. The following morning, it was presented to the vet
clinic with mild ataxia, mildly increased respiratory effort, mildly reduced gag reflex. It was
also reported to be off food since last night along with having vomited overnight. Diagnosed with
Tick Paralysis (grade 1B) and was treated with 0.5 ml Niramine (Chlorphenamine maleate) IM, 8ml
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
0.5 ml Niramine (Chlorphenamine maleate) IM, 8ml Tick Anti Serum (diluted with 8 ml saline given
over 1 hr) along with 0.6ml Cerenia (maropitant citrate, slow IV) and IV fluids were run
throughout hospitalisation
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
0
1
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
See continuation page
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): given monthly for an unknown time,
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product is labelled to kill >95% of paralysis ticks within 48 hours and to minimise the risk
of tick paralysis. However the label states that treatment with the product alone will not
entirely remove the risk of tick paralysis. Daily searching for and removal of ticks is
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 26-Sep-2017 at 21:35
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000624
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
7. R EACT ION D AT A (continued)
Adverse Events
Tick Anti Serum (diluted with 8 ml saline given over 1 hr) along with 0.6ml Cerenia (maropitant
citrate, slow IV) and IV fluids were run throughout hospitalisation. The owner then elected to
take the dog home and the current condition of the dog is unknown. It should be noted that the
dog was given NEXGARD every month for an unknown time without any adverse events. This is the
extent of the information available., (Outcome : Unknown)
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S) (continued)
Previous exposure to the suspect product 1 - continued:
estimated 1st jan 2017
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
recommended. There is no clear evidence that the product hasn't performed according to its label
claim for control of ticks. Assessed O1
Version : 26-Sep-2017 at 21:35
From:
S 47F
To:
AERP
Subject:
Nexgard Spectra - 17AU000444
Date:
Friday, 11 August 2017 12:06:39 PM
Attachments:
image001.jpg
17AU000444_Nexgard Spectra.pdf
Hi S 47F
Please find attached a serious suspected AE report following administration of Nexgard Spectra Chewables for Dogs.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and regulations,
all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission that our product caused or
contributed to the AE. Confounding factors such as concurrently administered drugs, environmental factors, and medical
history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Boehringer Ingelheim Animal Health
Level 1, 78 Waterloo Road, North Ryde NSW 2113, Australia
S 47F
Email_Signature_600px_FINAL
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000444
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Attending Veterinarian
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
6-Aug-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Maltese
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
5.2
6 Year(s) *
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasiticide
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA S; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 18.75 MG / MILBEMYCIN OXIME 3.75
Unknown
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Parasiticide
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
1-Jun-2017*
1-Aug-2017*
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
* approximate
Version : 10-Aug-2017 at 17:31
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000444
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
1-Aug-2017*
D u ra tio n o f re a c tio n :
0 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the vet, a 5 year 8 month old, Maltese, weighing 5.2kg, received one dosage form
of NEXGARD SPECTRA CHEWABLES FOR SMALL DOGS (AFOXOLANER 18.75 MG / MILBEMYCIN OXIME 3.75 MG,
unknown batch and expiry), administered orally by the owner as a parasiticide on an unknown date,
estimated 1st of August 2017. Approximately 3.5 hours later, the dog had a seizure and had about
4 – 6 seizures within the next 3 hours. Veterinary attention was sought and it was treated with
Valium (diazepam) and is reported to have recovered. Blood tests conducted during the visit were
unremarkable. The dog has received NEXGARD on two prior occasions, estimated to be on 1st of June
and 1st July. It should be noted that dog experienced a seizure 12 months ago following
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
Valium (diazepam)
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
1
0
D a te w h e n :
1-Aug-2017*
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
See continuation page
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Three doses total,estimated to be on 1st
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
P o ssib le
R e a so n fo r c la ssific a tio n :
See continuation page
The chronology supports a possible product association and seizures have very rarely been
reported temporal to use of isoxazoline class products. It should be noted that the dog has a
pre-existing history of seizures and in the absence of further information, other causes remain
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
* approximate
Version : 10-Aug-2017 at 17:31
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000444
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
MG CHEWABLE TABLETS
7. R EACT ION D AT A (continued)
Adverse Events
administration of a Bravecto (Fluralaner) chew. This is the extent of the information available.,
(Outcome : Recovered)
Medical History
Seizure
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S) (continued)
Previous exposure to the suspect product 1 - continued:
of June, July and Aug 2017
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
plausible. The case is assessed B
Version : 10-Aug-2017 at 17:31
From:
S 47F
To:
AERP
Subject:
17AU000663Nexgard AE
Date:
Friday, 13 October 2017 3:23:42 PM
Attachments:
image001.jpg
image002.jpg
image003.jpg
image004.jpg
image005.jpg
image006.jpg
17AU000663 Nexgard ae.pdf
Dear S 47F
Please find attached details of a suspected lack of efficacy experience report following
administration of Nexgard Chewables for Dogs 10.1 - 25 kg (APVMA No. 67940).
The Merial reference number for this case is 17AU000663.
Please do not hesitate to contact us if anything further is required.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal
requirements and regulations, all adverse events (AE) are recorded. Collection of an AE report
does not constitute an admission that our product caused or contributed to the AE. Confounding
factors such as concurrently administered drugs, environmental factors, and medical history of
the animal must be considered when evaluating AE reports.
Kind regards,
S 47F
Senior Regulatory Associate
S 47F
Merial is now part of Boehringer Ingelheim
Follow Merial:
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VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000663
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Owner
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
2-Oct-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 1
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Border Collie mixed w. Canine (unknown)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
19.5
3 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67940
NEXGARD CHEWABLES FOR DOGS 10.1-25 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 68 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
29-Sep-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 12-Oct-2017 at 23:57
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000663
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
29-Sep-2017
D u ra tio n o f re a c tio n :
12 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the owner, Gus; a 3 yr old, 19.5 Kg, male, neutered, Border Collie cross was given
PO one dosage form of NEXGARD CHEWABLES FOR DOGS 10.1-25 kg (68 mg Afoxolaner, batch and expiry
unknown) for flea and tick control on the 29th SEPT 2017 by the owner. Approx 12 hours later, the
dog was lethargic, vomiting water, twitching in his sleep, not able to keep his head up. Since
the 30th, it had not eaten.Vet attention was sought on the 1st of Oct which noted the lethargy,
inappetance and vomiting. Physical examination was normal except that the animal was found to be
quite gassy. Cerenia Inj (Maropitant citrate)10mg/ml was administered and the dog was sent home.
Second vet was consulted on 2 OCT 2017 who found no abnormailites on examination. Blood tests
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
Cerenia Inj (Maropitant citrate)10mg/ml was administered, rimadyl, with IV fluids, methadone,
O2,
enrofloxacin and amoxicillin, CPR (atropine and adrenaline)
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
1
0
0
0
0
D a te w h e n :
11-Oct-2017
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s):
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
U n lik e ly
R e a so n fo r c la ssific a tio n :
See continuation page
The chronology of the onset of the adverse events is consistent with the pharmacological profile
of the product and vomiting, lethargy and inappetence are known side effects of this product;
however the remaining signs are unexpected. The diagnosis of marked pyothorax is suspected as the
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 12-Oct-2017 at 23:57
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000663
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
7. R EACT ION D AT A (continued)
Adverse Events
revealed mild anaemia, increased white blood cell count due to neutrophilia, elevated ALT, ALP,
GGT and bilirubin. Revisit 3 OCT 2017 and found to now be jaundiced mildly. Treated 3 OCT 2017
with denosyl 225mg bid and cerenia again. 6 OCT 2017 revisit as dog still inappetant and
jaundiced, has lost weight. Still anaemic, neutrophils now normal, ALT, ALP, GGT and bilirubin
still elevated. Lipase also elevated. Treated with rimadyl 25mg bid. It should be noted that the
vet suspicion is low. 9 OCT 2017 the owner reports the dog is back to normal.11 OCT 2017
Presented to an emergency center with laboured breathing in lateral recumbency. Also lethargic
and minimally responsive. Rapid breathing. Clinical exam revealed marked pleural effusion
(pyothorax diagnosed on aspiration), hypotension, poor perfusion, severe metabolic acidosis.
While treating (with IV fluids, methadone, O2, enrofloxacin and amoxicillin), the dog went into
cardiac and respiratory arrest. CPR performed (including atropine and adrenaline). Owner elected
to cease CPR and the animal died. This is the extent of the information available., (Outcome :
Death (All Causes))
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
primarily causal agent for the signs seen. Assessed N.
Version : 12-Oct-2017 at 23:57
From:
S 47F
To:
AERP
Subject:
Re: [APVMA-securemail] Online report for Nexgard [DLM=Sensitive]
Date:
Sunday, 25 February 2018 6:09:51 PM
Attachments:
image001.jpg
18AU000226_Nexgard.pdf
Hi S 47F
Thanks for reporting this to us. We didn't have a match for this case in our system. Report
with company assessment attached.
Kind regards
S 47F
----- Original Message -----
From: AERP
Date: Tue, 20 Feb 2018 04:15:41 +0000
To: S 47F
Subject: [APVMA-securemail] Online report for Nexgard [DLM=Sensitive]
Sensitive
Good afternoon S 47F
The APVMA has received the following report for Nexgard.
Please would you kindly review your systems for a match? We would
appreciate classification and comment by Friday 23rd March, 2018.
With thanks,
S 47F
S 47F
Team Member Adverse Experience Reporting Program (AERP)
Australian Pesticides and Veterinary Medicines Authority (APVMA)
PO Box 6182 Kingston ACT 2604
Report Generated Tue Feb 20 15:15:08 AEDT 2018
Adverse Experience Report S-17-53059-V
General Details
Report
S-17-53059-V
Type
Veterinary
Category Standard
Number
Date
Category
Standard
Scheme
Voluntary
16/11/2017
Received
Report
2017
Priority
Low
Status
Initial
Year
Web
Country
Australia
Reference
Comments 4174
Registrant Details
Registrant
Registrant
Web ref 4174
Reference
Received
Products
Product 1
Product
Expiry
Chemical VET * SMALL ANIMALS
67939
30/06/2018
Number
Date
Class
- EXTERNAL
Product
NEXGARD CHEWABLES FOR DOGS 25.1-50 KG
Name
Registrant MERIAL AUSTRALIA PTY LTD
Active(s)
AFOXOLANER
Comments
Animals
Animal 1
Species
Canine
Breed
Schnauzer
Sex
Male
Not
Production
Physiological
Health
Companion
applicable
Type
Status
Status
(male)
Min Age
Max Age
Avg Age
5years
Min
Avg
Max Weight
42kg
Weight
Weight
No
No
1
No Affected 1
Treated
Destroyed
Incident
1 chewable tablet given according to instructions to 42kg dog.
Russian Black Terrier. This has medicine never been used in this
dog before. Dog has been previously healthy with no signs of
neurological conditions. Two days later, dog now bites at air at
non-existant flies - seems to be known as "fly biting syndrome".
Events
This has never happened before. Searching for information on
Following
"fly biting" seems to indicate many other dog owners who have
Treatment
similarly given their dog Nexgard and this condition appearing on
first dose. It does not resolve for many. Australian web site says
"Use with caution in dogs with a history of epilepsy or any other
seizure disorder. " This information is not on the leaflet inside the
package or on the packaging. This dog has no prior history of
epilepsy or seizures. Very distressing for dog.
Event
Ongoing
Outcome
Professional
Report
Pathology
Results
APVMA
Comments
Safety/Efficacy
Citations
Presenting
Signs
Safety/Efficacy
Citations
Date of
Presenting
14/11/2017
Signs
Presenting
Signs
Treatment
Administered
Route of
Initial
Owner
By
Exposure
Treatment Date
Final
Treatment
Exposure/Onset
Treatment
48 hours
Time
Interval
Date
Treatment
Dose
Frequency of
Administration
Duration of
Adverse
ongoing
Experience
Pest/Purpose
flea control
Used
According to
Yes
Label
Stored
According to
Yes
Label
Date of
Outcome
Adverse Experience Report S-17-53059-V
Sensitive
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VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
18AU000226
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Regulatory authority
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
21-Feb-2018
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r: Regulatory authority
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Terrier Breeds (500 Series)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
42
5 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasite control
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67939
NEXGARD CHEWABLES FOR DOGS 25.1-50 KG; Dosage Form: Tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 136 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: Unknown
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Parasite control
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
12-Nov-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 25-Feb-2018 at 02:00
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
18AU000226
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
14-Nov-2017
D u ra tio n o f re a c tio n :
Unknown
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
Adverse Events
As reported by the regulatory authority, a 42kg 5 year old male Black Russian Terrier was given
PO one dosage form of NEXGARD CHEWABLES FOR DOGS 25.1-50kg (Afoxolaner 136 mg, batch and expiry
unknown) for parasite control by the owner on the 12 NOV 2017. Within 2 days the dog started "fly
biting". It is unknown if any veterinary attention has been sought and the condition was ongoing
at the time of the report to the regulatory authority (16 NOV 2017). This is the extent of the
information available., (Outcome : Unknown)
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
0
1
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s):
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
The chronology of the onset of the adverse event is consistent with the pharmacological profile
of the product; however the signs seen are not expected following labelled use of the product.
Assessed O1.
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 25-Feb-2018 at 02:00
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
18AU000226
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
Version : 25-Feb-2018 at 02:00
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000698
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Veterinary Nurse/Technician
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
10-Oct-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r: Veterinary Nurse/Technician
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Terrier (Jack Russell)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
5.2
8 Month(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasiticide
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA S; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 18.75 MG / MILBEMYCIN OXIME 3.75
Unknown
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Parasiticide
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
RVT / Assistant
1-Apr-2017*
8-Sep-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Treatment / vaccination program not
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
* approximate
Version : 18-Oct-2017 at 05:07
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000698
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
10-Oct-2017
D u ra tio n o f re a c tio n :
Ongoing
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the Vet Nurse, Scruffy; an 8 month old, 5.2 Kg, female, desexed Jack Russell
Terrier was given PO one dosage form of NEXGARD SPECTRA CHEWABLES FOR DOGS 3.6-7.5 kg (18.75 mg
Afoxolaner 3.75 mg Milbemycin, batch and expiry unknown) for internal and external parasites on
the 8th of SEPT 2017 by a vet nurse. On 10 OCT 2017, the dog presented to the clinic with signs
of tick paralysis. Note that the dog was overdue (2 days) for its monthly dose of NEXGARD
SPECTRA. A half engorged tick was found behing the right ear near the collar. Tick paralysis
score 2B; able to stand unaided but cannot walk with elevated respiratory and heart rate. Treated
with anamav (atropine/acp) 0.3ml, 0.5ml histamil (chlorpheniramine) and 8ml tick anti-serum. 11
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
anamav (atropine/acp) 0.3ml, 0.5ml histamil (chlorpheniramine) and 8ml tick anti serum, fluids,
cerenia (maropitant), enrotril (enrofloxacin), Zantac
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
1
0
0
0
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): since April 2017
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product is labelled to kill >95% of paralysis ticks within 48 hours and to minimise the risk
of tick paralysis. However the label also states that treatment with the product alone will not
entirely remove the risk of tick paralysis. Daily searching for and removal of ticks is
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 18-Oct-2017 at 05:07
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000698
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
MG CHEWABLE TABLETS
Use according to label - continued
respected
7. R EACT ION D AT A (continued)
Adverse Events
OCT 2017 the dog had improved but had some vomiting. Given anamav 0.25ml to sedate. 12 OCT 2017
Still some vomiting. Given subcutaneous fluids 40ml. 13 OCT 2017 Placed on IV fluids as still
vomiting. Gave cerenia (maropitant), enrotril (enrofloxacin) and anamav. 14 OCT 2017 another tick
found (dead). Given Zantac syrup x 20. The current status of the dog is unknown. This is the
extent of the information available., (Outcome : Remains under treatment)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
recommended. The dog was also overdue it's monthly treatment and there is no clear evidence that
the product hasn't performed according to its label claim for control of ticks. Assessed O1.
Version : 18-Oct-2017 at 05:07
From:
S 47F
To:
AERP
Subject:
Nexgard Spectra - 17AU000698 and 17AU000710
Date:
Wednesday, 18 October 2017 8:25:30 PM
Attachments:
image001.jpg
17AU000698_Nexgard Spectra.pdf
17AU000710_Nexgard Spectra.pdf
Hi S 47F
Please find attached two suspected lack of efficacy report following Nexgard Spectra administration.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000710
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Attending Veterinarian
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Austria Office
Australian Pesticides and Veterinary
Austria
Medicines Authority
PO Box E240
Kingston ACT 2604
D a t e c o m p la in t re c e iv e d b y s e n d e r:
12-Oct-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Staffordshire Terrier
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
22
Unknown
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA L; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 75 MG / MILBEMYCIN OXIME 15 MG
Unknown
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
14-Sep-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 18-Oct-2017 at 04:58
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000710
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
1-Oct-2017
D u ra tio n o f re a c tio n :
10 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the attending veterinarian, a 22kg female desexed Staffordshire Terrier was given
PO one dosage form of NEXGARD SPECTRA CHEWABLES FOR DOGS 15.1-30 kg (75 mg Afoxolaner 15 mg
Milbemycin, batch and expiry unknown) for internal and external parasites on the 14 SEP 2017 by
the owner. 1 OCT 2017 the dog was ataxic, had elevated respiratory effort and a paralysis tick
found on her body (not identified microscopically). Was treated with tick antiserum,
dexamethasone and histamil (chlorpheniramine). Discharged 2 OCT 2017. 11 OCT 2017 the dog had
elevated respiratory effort again. Was examined by a vet, no treatment instituted and recovered.
This is the extent of the information available., (Outcome : Recovered)
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
tick antiserum, dexamethasone and histamil (chlorpheniramine)
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
1
0
D a te w h e n :
11-Oct-2017
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Unknown
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e : Unknown
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product does not have a claim to prevent tick paralysis. The label claim is for the control
of Ixodes holocyclus for 4 weeks after application. The label also states that use of the product
does not guarantee prevention of tick paralysis because ticks are not killed immediately after
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 18-Oct-2017 at 04:58
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000710
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
CHEWABLE TABLETS
7. R EACT ION D AT A (continued)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
attachment. Daily searching of dogs is necessary to minimise the risk of tick paralysis and in
this case the owner was not conducting daily searches. The case is assessed O1.
Version : 18-Oct-2017 at 04:58
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000704
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Veterinary Nurse/Technician
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
11-Oct-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r: Veterinary Nurse/Technician
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 1
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Canine (unknown)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
Unknown
Unknown
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67940
NEXGARD CHEWABLES FOR DOGS 10.1-25 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 68 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: Unknown
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
Unknown
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Unknown
Unknown
1-Oct-2017*
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
* approximate
Version : 19-Oct-2017 at 17:21
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000704
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
5-Oct-2017*
D u ra tio n o f re a c tio n :
0 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
Adverse Events
As reported by the vet nurse, a dog of unknown signalment received an unknown dose of NEXGARD
CHEWABLES FOR DOGS (product unsubstantiated, batch and expiry unknown) administered on an unknown
date estimated 1st OCT 2017. ‘A short time’ later the dog died of suspected heart failure. There
is another similar case reporter by the same person, 17AU000705. This is the extent of
information available., (Outcome : Death (All Causes))
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
1
0
0
0
0
D a te w h e n :
5-Oct-2017*
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Unknown
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e : Unknown
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
U n c la ssifie d
R e a so n fo r c la ssific a tio n :
The reported signs are not expected and the case information provided is insufficient to assess
causality. Assessed O.
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
* approximate
Version : 19-Oct-2017 at 17:21
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000704
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
Version : 19-Oct-2017 at 17:21
From:
S 47F
To:
AERP
Subject:
Suspected AE reports - Nexgard S 22
Date:
Friday, 20 October 2017 8:49:53 AM
Attachments:
image001.jpg
17AU000704_Nexgard.pdf
17AU000705_Nexgard.pdf
S 22
Hi S 47F
Please find attached three serious suspected adverse event reports
· 17AU000704 – Nexgard Chewables for Dogs
· 17AU000705 - Nexgard Chewables for Dogs
· S 22
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000705
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Veterinary Nurse/Technician
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
11-Oct-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r: Veterinary Nurse/Technician
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 1
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Canine (unknown)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
Unknown
Unknown
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67940
NEXGARD CHEWABLES FOR DOGS 10.1-25 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 68 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: Unknown
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
Unknown
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Unknown
Unknown
1-Sep-2017*
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
* approximate
Version : 19-Oct-2017 at 17:37
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000705
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
15-Sep-2017*
D u ra tio n o f re a c tio n :
0 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
Adverse Events
As reported by the vet nurse, a dog of unknown signalment received an unknown dose of NEXGARD
CHEWABLES FOR DOGS (product unsubstantiated, batch and expiry unknown) administered on an unknown
date estimated 1st SEPT 2017. Approx 2 weeks later,the dog died of suspected heart failure. This
is the extent of information available., (Outcome : Death (All Causes))
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
1
0
0
0
0
D a te w h e n :
15-Sep-2017*
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Unknown
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e : Unknown
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
U n c la ssifie d
R e a so n fo r c la ssific a tio n :
Although there is a chronological link, heart failure and death are not expected following
labelled use of the product. There is insufficient information to assess causality - case
assessed O.
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
* approximate
Version : 19-Oct-2017 at 17:37
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000705
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
Version : 19-Oct-2017 at 17:37
From:
S 47F
To:
AERP
Subject:
17AU000579 Nexgard Spectra SAE
Date:
Monday, 18 September 2017 12:37:45 PM
Attachments:
image001.png
17AU000579 nexgard spectra sae.pdf
Dear S 47F
Please find attached report of a serious Suspected Lack of Efficacy Report following
administration of NEXGARD SPECTRA (APVMA No 81055).
The BI Internal reference number for this case is 17AU000579.
Please do not hesitate to contact us if any further information is required.
In accordance with global company policy, legal requirements and regulations, all adverse events
(AE) are recorded. Collection of an AE report does not constitute an admission that our product
caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE
reports.
Kind regards,
S 47F
Senior Regulatory Affairs Associate
Boehringer Ingelheim Animal Health
S 47F
cid:image001.png@01D3307A.509BD690
Making more health for patients, our people and our community.
This e-mail is confidential. If you are not the intended recipient you must not disclose or use the information contained in it. If you
have received this e-mail in error, please notify the sender immediately and then delete it. You should not copy, use, disclose or
distribute this e-mail without the author's permission. For general inquiries please call 1800 808 691.
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000579
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Owner
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
6-Sep-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 3
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 1
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Canine Other
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
21
19 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasiticide
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA XL; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 150 MG / MILBEMYCIN OXIME 30 MG
Unknown
B a tc h N o .: AA186116
E xp iry d a te :
S to ra g e d e ta ils:
31-Aug-2019
Unknown
T re a tme n t D e ta ils: Parasiticide
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
0.25 Dose per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
30-Jul-2017*
4-Sep-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Low dose, Off label use / Indication,
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
* approximate
Version : 14-Sep-2017 at 21:10
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000579
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
5-Sep-2017
D u ra tio n o f re a c tio n :
3 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the owner,Bundy; a 19 year old, 21 kg, male, neutered, Cattle dog received 1/4th
dosage form PO of NEXGARD SPECTRA 30.1 - 60kgs Afoxolaner 150MG / Milbemycin Oxime 30MG (batch
AA1861/16 Exp 08/2019) administered by the owner for internal and external parasites on the 4th
SEPT 2017. The next morning the dog became very lethargic and appeared unconscious. On the 6th
Sept the dog vomited and ‘urinated inside the house’. On the 7th Sept the dog had another vomit
and continued to be lethargic and not moving. It was reported on the 8th that the dog had a few
vomits overnight, had a 'big poo' and had passed away this morning. No veterinary examination was
conducted. It should be noted that the dog has had this product before and had a different
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
1
0
0
0
0
D a te w h e n :
8-Sep-2017
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Previous month
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e : Similar reaction
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The chronology of the onset of the vomiting and lethargy are consistent with the pharmacological
profile of the product; however inappropriate urination and death are not expected following
labelled use of the product. The product was used at an off label dosage and the patient had
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 14-Sep-2017 at 21:10
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000579
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
CHEWABLE TABLETS
Use according to label - continued
Treatment / vaccination program not respected
7. R EACT ION D AT A (continued)
Adverse Events
reaction (17AU000582). It should be noted that veterinary consultation on the 24 AUG identified
preexisting conditions: chronic arthritis, abdominal mass (enlarged liver identified at a
previous undisclosed time via ultrasound), bilateral cateracts and deafness. Additionally 2 other
dogs in the household were treated at the same time with no reaction. This is the extent of the
information available., (Outcome : Death (All Causes))
Medical History
chronic arthritis, abdominal mass (enlarged liver identified at a previous undisclosed time via
ultrasound), bilateral cateracts and deafness
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
multiple pre-existing conditions as a confounding factor. Assessed O1.
Version : 14-Sep-2017 at 21:10
From:
S 47F
To:
AERP
Subject:
Nexgard Spectra - 17AU000750
Date:
Monday, 30 October 2017 10:12:21 AM
Attachments:
image001.jpg
17AU000750_Nexgard Spectra.pdf
Hi S 47F
A suspected lack of efficacy report for Nexgard Spectra attached – 17AU000750.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000750
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Owner
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
22-Oct-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
West Highland White
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
3.6
3 Month(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasiticide
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA XS; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 9.38 MG / MILBEMYCIN OXIME 1.88
Unknown
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Parasiticide
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
21-Oct-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Low dose
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 26-Oct-2017 at 23:54
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000750
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
21-Oct-2017
D u ra tio n o f re a c tio n :
Ongoing
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the owner, Atticus, a 3 month old, 3.6kg, male, intact, West Highland Terrier
received one dosage form of NEXGARD SPECTRA XS (AFOXOLANER 9.38 MG / MILBEMYCIN OXIME 1.88 MG,
Batch and Expiry unknown), administered orally by the local vet for paralysis tick control on 21
October 2017 morning. The dog was presented to the vet on suspicion of tick paralysis due to its
loss of voice but no tick was found at the time. Four hours later the dog vomited saliva. The
owner then found a tick that evening, removed it and took the dog to an emergency vet. Diagnosis
of stage 2B tick paralysis (mild) as there was some loss of gag and menace and mild ataxia. There
was also some anxiety with oral handling. Treatment of 0.03 ml acepromazine i/v, 0.06ml i/v
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
Treatment of 0.03 ml acepromazine i/v, 0.06ml i/v methamphetamine, Tick Anti Serum i/v 5mls and
0.25ml i/v Metomide (Metoclopramide).
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
0
1
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s):
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
U n lik e ly
R e a so n fo r c la ssific a tio n :
See continuation page
The dog was infested with a tick and showing signs of tick paralysis prior to product
administration. The product is labelled to kill >95% of paralysis ticks within 48 hours and to
minimise the risk of tick paralysis. There is no evidence that the product hasn't performed
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 26-Oct-2017 at 23:54
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000750
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
MG CHEWABLE TABLETS
7. R EACT ION D AT A (continued)
Adverse Events
methamphetamine, Tick Anti Serum i/v 5mls and 0.25ml i/v Metomide (Metoclopramide). The dog was
kept overnight for observation and at the time of reporting was still not able to move. This is
the extent of the information available., (Outcome : Ongoing)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
according to its label claim for control of ticks. Based on clinical judgement, case assessed N.
Version : 26-Oct-2017 at 23:54
From:
S 47F
To:
AERP
Subject:
RE: Nexgard - 17AU000767
Date:
Monday, 30 October 2017 3:19:50 PM
Attachments:
image001.jpg
17AU000767_Nexgard.pdf
Hi S 47F
A suspected lack of efficacy report for Nexgard Chewables attached – 17AU000767.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000750
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Owner
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
22-Oct-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
West Highland White
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
3.6
3 Month(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasiticide
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA XS; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 9.38 MG / MILBEMYCIN OXIME 1.88
Unknown
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Parasiticide
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
21-Oct-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Low dose
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 26-Oct-2017 at 23:54
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000750
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
21-Oct-2017
D u ra tio n o f re a c tio n :
Ongoing
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the owner, Atticus, a 3 month old, 3.6kg, male, intact, West Highland Terrier
received one dosage form of NEXGARD SPECTRA XS (AFOXOLANER 9.38 MG / MILBEMYCIN OXIME 1.88 MG,
Batch and Expiry unknown), administered orally by the local vet for paralysis tick control on 21
October 2017 morning. The dog was presented to the vet on suspicion of tick paralysis due to its
loss of voice but no tick was found at the time. Four hours later the dog vomited saliva. The
owner then found a tick that evening, removed it and took the dog to an emergency vet. Diagnosis
of stage 2B tick paralysis (mild) as there was some loss of gag and menace and mild ataxia. There
was also some anxiety with oral handling. Treatment of 0.03 ml acepromazine i/v, 0.06ml i/v
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
Treatment of 0.03 ml acepromazine i/v, 0.06ml i/v methamphetamine, Tick Anti Serum i/v 5mls and
0.25ml i/v Metomide (Metoclopramide).
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
0
1
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s):
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
U n lik e ly
R e a so n fo r c la ssific a tio n :
See continuation page
The dog was infested with a tick and showing signs of tick paralysis prior to product
administration. The product is labelled to kill >95% of paralysis ticks within 48 hours and to
minimise the risk of tick paralysis. There is no evidence that the product hasn't performed
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 26-Oct-2017 at 23:54
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000750
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
MG CHEWABLE TABLETS
7. R EACT ION D AT A (continued)
Adverse Events
methamphetamine, Tick Anti Serum i/v 5mls and 0.25ml i/v Metomide (Metoclopramide). The dog was
kept overnight for observation and at the time of reporting was still not able to move. This is
the extent of the information available., (Outcome : Ongoing)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
according to its label claim for control of ticks. Based on clinical judgement, case assessed N.
Version : 26-Oct-2017 at 23:54
From:
S 47F
To:
AERP
Subject:
17AU000452 Nexgard AE
Date:
Wednesday, 27 September 2017 9:36:23 AM
Attachments:
image001.jpg
image002.jpg
image003.jpg
image004.jpg
image005.jpg
image006.jpg
17AU000452 nexgard ae.pdf
Dear S 47F
Please find attached details of a suspected adverse experience report following administration of
Nexgard Chewables for Dogs 2 - 4 kg (APVMA No. 67942).
Please do not hesitate to contact us if anything further is required.
Kind regards,
S 47F
Senior Regulatory Associate
S 47F
Merial is now part of Boehringer Ingelheim
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VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000452
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Owner
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
9-Aug-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Shih Tzu mixed w. Poodle (Toy)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
3.5
10 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Unknown
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67942
NEXGARD CHEWABLES FOR DOGS 2-4 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 11.3 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: BA12616
E xp iry d a te :
S to ra g e d e ta ils:
31-Mar-2018
Unknown
T re a tme n t D e ta ils: Unknown
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
17-Jul-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 26-Sep-2017 at 19:30
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000452
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
22-Jul-2017
D u ra tio n o f re a c tio n :
Ongoing
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the owner, Jessie, a female, neutered, 10 year old, Shih Tzu x Toy Poodle,
weighing 3.5kg, received one dosage form of NEXGARD CHEWABLES FOR DOGS 2-4 KG (AFOXOLANER 11.3 MG
CHEWABLE TABLETS), batch BA1026/16 and expiry March 2018, administered orally by the owner for
flea and tick control on the 17 July 2017. Five days later (22nd July 2017) the dog had its
first seizure followed by another three seizures (3-5 days apart) lasting between 3-7 minutes
decreasing in time, for a few minutes after each seizure the dog was not moving freely, then for
the next 30 mins to 1 hour the dog seemed ‘upset’, the dog was examined by a vet (bloods
unremarkable) but no treatment was administered. The dog is well but not 100%. This is the
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
valium, alfaxan, isoflurane and IVFT. Started on phenomav 7.5mg bid, diazepam, levetiracetam,
phenobarbitone
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
0
1
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s):
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
P o ssib le
R e a so n fo r c la ssific a tio n :
See continuation page
Seizures have very rarely been reported temporal to use of isoxazoline class products, and the
chronology to onset is consistent with the pharmacological profile of the product however other
causes remain plausible. Case assessed B - possible. UPDATED 19 SEP17 SF: Assessment remains
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 26-Sep-2017 at 19:30
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000452
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
7. R EACT ION D AT A (continued)
Adverse Events
extent of the information available. UPDATE 19 SEP 17 SF: 18 AUG 17 Dog had 3 seizures and was
taken to the local vet in status epilepticus. Was treated with valium, alfaxan, isoflurane and
IVFT. Started on phenomav 7.5mg bid. 14 SEP 17 Seizuring again (clusters). Missed phenomav dose
this morning. Taken to local vet and treated with Valium. Recovered and sent home. Went to
emergency centre overnight in status epilepticus. Treated with diazepam, levetiracetam,
phenobarbitone. Found to be slightly hypernatraemic but otherwise tests were unremarkable. The
outcome is unknown. This is the extent of the information available., (Outcome : Ongoing)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
unchanged.
Version : 26-Sep-2017 at 19:30
From:
S 47F
To:
AERP
Subject:
17AU000S 22
609 S 22
Nexgard spectra AE
Date:
Friday, 22 September 2017 4:37:23 PM
Attachments:
image001.png
S 22
17AU000609 nexgard spectra ae.pdf
Dear S 47F
Please find attached reports of serious Suspected Adverse Experience Reports following
administration of:
S 22
3. Nexgard Spectra for dogs 3.6 - 7.5 kg (APVMA No. 81010)
The BI Internal reference numbers for these cases are:
S 22
3. 17AU000609
Please do not hesitate to contact us if any further information is required.
In accordance with global company policy, legal requirements and regulations, all adverse events
(AE) are recorded. Collection of an AE report does not constitute an admission that our product
caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE
reports.
Kind regards,
S 47F
Senior Regulatory Affairs Associate
Boehringer Ingelheim Animal Health
S 47F
Making more health for patients, our people and our community.
This e-mail is confidential. If you are not the intended recipient you must not disclose or use the information contained in it. If you
have received this e-mail in error, please notify the sender immediately and then delete it. You should not copy, use, disclose or
distribute this e-mail without the author's permission. For general inquiries please call 1800 808 691.
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000609
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Attending Veterinarian
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
18-Sep-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Maltese
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
6.9
2 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasiticide
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA S; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 18.75 MG / MILBEMYCIN OXIME 3.75
Unknown
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Parasiticide
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
6-Sep-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 22-Sep-2017 at 02:11
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000609
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
18-Sep-2017
D u ra tio n o f re a c tio n :
2 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
Adverse Events
As reported by the attending vet, Chewie; a 6.9 kg, 2 yr old, male, neutered, Maltese received
one dosage form PO of NEXGARD SPECTRA 3.6-7.5kgs (Afoxolaner 18.75MG / Milbemycin Oxime 3.75MG ,
batch and expiry unknown) administered by the vet for internal and external parasites on 6th Sept
2017. On the 18th Sept 2017, the dog was presented to the clinic as it was showing signs of tick
paralysis. The vet located a tick and and treated with butorphanol, tick anti serum, ACP, IV
fluids clavulox and oxygen. Recovered by 20 SEP 17 and went home. This is the extent of the
information available., (Outcome : Recovered)
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
butorphanol, tick anti serum, ACP, IV fluids clavulox and oxygen
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
1
0
D a te w h e n :
20-Sep-2017
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s):
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product is labelled to kill >95% of paralysis ticks within 48 hours and to minimise the risk
of tick paralysis. However the label also states that treatment with the product alone will not
entirely remove the risk of tick paralysis. Daily searching for and removal of ticks is
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 22-Sep-2017 at 02:11
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000609
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
MG CHEWABLE TABLETS
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
recommended. There is no clear evidence that the product hasn't performed according to its label
claim for control of ticks. Assessed O1.
Version : 22-Sep-2017 at 02:11
From:
S 47F
To:
AERP
Subject:
Nexgard Spectra - 17AU000793
Date:
Saturday, 11 November 2017 7:32:56 AM
Attachments:
image001.jpg
17AU000793_Nexgard Spectra.pdf
Hi S 47F
A suspected lack of efficacy report for Nexgard Spectra attached – 17AU000793.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000793
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Attending Veterinarian
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
6-Nov-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Mixed Terrier Breeds (500 Series)
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
8.8
5 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasite control
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA M; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 37.50 MG / MILBEMYCIN OXIME 7.50
Unknown
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Parasite control
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
Unknown
21-Oct-2017*
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
* approximate
Version : 10-Nov -2017 at 15:28
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000793
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
2-Nov-2017
D u ra tio n o f re a c tio n :
Ongoing
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the attending vet, Sid; a 5 year old, 8.8 Kg, male, desexed, wire haired terrier x
was given PO one dosage form of NEXGARD SPECTRA CHEWABLES FOR DOGS 7.6-15 kg (37.5 mg Afoxolaner
and 7.5 Milbemycin oxime, batch and expiry unknown) for flea and tick control on approx. the 21
OCT 2017 by the Owner. On the 2nd NOV, the dog vomited once, on 3rd, was lethargic and vomited.
He got worse on 5th NOV with increased vomiting. Presented to the clinic on the 6th of NOV with
vomiting/gagging, very mild increase in respiratory effort, weak on standing but not ataxic.
Physical examination found that the ears were swollen and gunky (right worse). On tick search,
vet found and removed an engorged adult paralysis tick from the end of the nose and was diagnosed
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
sedated with 0.2 ml Acepromazine maleate injection and 0.2 ml Methone (methadone)injection. IV
catheter was placed and fluids started, Tick Anti Serum (TAS) administered (20 ml of TAS in
50:50
dilution given over an hour) followed by 3 ml of Metomide (metoclopramide) injection in 1L
saline at maintenance were administered.
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
1
0
0
0
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Unknown
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e : Unknown
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product is labelled to kill >95% of paralysis ticks within 48 hours and to minimise the risk
of tick paralysis. The label indicates that treatment with the product alone will not entirely
remove the risk of tick paralysis as ticks are not killed immediately and daily searching for and
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 10-Nov -2017 at 15:28
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000793
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
MG CHEWABLE TABLETS
7. R EACT ION D AT A (continued)
Adverse Events
with grade 1A tick paralysis. Dog was sedated with 0.2 ml Acepromazine maleate injection and 0.2
ml Methone (methadone) injection, then clipped but no other ticks were found. IV catheter was
placed and fluids started, Tick Anti Serum (TAS) administered (20 ml of TAS in 50:50 dilution
given over an hour) followed by 3 ml of Metomide (metoclopramide) injection in 1L saline at
maintenance were administered. Dog was hospitalised with no other clinical signs observed and is
reported to have continued to improve. This is the extent of the information available.,
(Outcome : Ongoing)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
removal of ticks is recommended. There is no clear evidence that the product hasn't performed
according to its label claim for control of ticks. Assessed O1 - inconclusive.
Version : 10-Nov -2017 at 15:28
From:
S 47F
To:
AERP
Subject:
Nexgard - 17AU000866
Date:
Friday, 24 November 2017 1:52:36 PM
Attachments:
image001.jpg
17AU000866_Nexgard.pdf
Hi S 47F
Please find attached a suspected lack of efficacy report for Nexgard Chewables for Dogs.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000866
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Owner
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
20-Nov-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Mixed Fox Terrier
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
6
2 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67941
NEXGARD CHEWABLES FOR DOGS 4.1-10 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 28.3 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: BA115115
E xp iry d a te :
S to ra g e d e ta ils:
31-Oct-2017
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
1-Jul-2017
30-Oct-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 23-Nov -2017 at 18:39
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000866
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
19-Nov-2017
D u ra tio n o f re a c tio n :
2 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the owner, Buddy; a 6 kg, 2 yr old, male, neutered, Fox Terrier cross, received
one dosage form of NEXGARD CHEWABLES FOR DOGS 4.1-10kg (AFOXOLANER 28.3 MG CHEWABLE TABLETS,
batch BA1151/15, Expiry 10/2017) administered orally by the owner for flea and tick control on 30
OCT 2017. The dog has received Nexgard monthly since 1 July 2017. On 19th November 2017, the dog
was presented to the vet with marked ataxia and a tick was removed. The dog was observed to be
unable to move with slight respiratory distress. Acepromazine, Niramine (chlorpheniramine
maleate), Dexadreson (dexamethasone disodium phosphate), 10 ml of Tick Anti serum and Clavulox
injection (Amoxycillin) were administered and Advantix (imidacloprid / permethrin) was applied.
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
19 Nov-Acepromazine, Niramine (chlorpheniramine maleate), Dexadreson (dexamethasone disodium
phosphate), 10 ml of Tick Anti serum, Clavulox injection (Amoxycillin) and Advantix
(imidacloprid/permethrin). 20 NOV - Clavulox (Amoxycillin) injection BID and 21 NOV - Clavulox
(Amoxycillin) 0.5cc S/C
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
1
0
D a te w h e n :
21-Nov-2017
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): since 1st July 2017
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product is labelled to kill >95% of paralysis ticks within 48 hours and to minimise the risk
of tick paralysis. However the label also states that treatment with the product alone will not
entirely remove the risk of tick paralysis. Daily searching for and removal of ticks is
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 23-Nov -2017 at 18:39
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000866
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
7. R EACT ION D AT A (continued)
Adverse Events
The dog was hospitalised overnight, next day had improved and was able to walk, Clavulox
injection (Amoxycillin) was given BID. On 21st the dog was bright and alert, Clavulox
(Amoxycillin) 0.5cc S/C was administered and dog discharged that afternoon. This is the extent
of the information available., (Outcome : Recovered)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
recommended. There is no clear evidence that the product hasn't performed according to its label
claim for control of ticks. Assessed O1
Version : 23-Nov -2017 at 18:39
From:
S 47F
To:
AERP
Subject:
17AU000837 Nexgard LOE
Date:
Tuesday, 21 November 2017 11:19:53 AM
Attachments:
image001.png
17AU000837 Nexgard spectra LOE.pdf
Dear S 47F
Please find attached details of a suspected lack of efficacy experience report following
administration of Nexgard Spectra Chewables for Dogs 30.1 – 60 kg (APVMA No. 81055 ).
The Merial reference number for this case is 17AU000837.
Please do not hesitate to contact us if anything further is required.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal
requirements and regulations, all adverse events (AE) are recorded. Collection of an AE report
does not constitute an admission that our product caused or contributed to the AE. Confounding
factors such as concurrently administered drugs, environmental factors, and medical history of
the animal must be considered when evaluating AE reports.
Kind regards,
S 47F
S 47F
Senior Regulatory Affairs Associate
Boehringer Ingelheim Animal Health
S 47F
cid:image001.png@01D362B6.D972DDB0
Making more health for patients, our people and our community.
This e-mail is confidential. If you are not the intended recipient you must not disclose or use the information contained in it. If you
have received this e-mail in error, please notify the sender immediately and then delete it. You should not copy, use, disclose or
distribute this e-mail without the author's permission. For general enquiries please call 1800 808 691.
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000837
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Attending Veterinarian
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
14-Nov-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Retriever Labrador
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
36.2
7.9 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasiticide
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA XL; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 150 MG / MILBEMYCIN OXIME 30 MG
Unknown
B a tc h N o .: AB159616
E xp iry d a te :
S to ra g e d e ta ils:
31-Aug-2019
Unknown
T re a tme n t D e ta ils: Parasiticide
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
5-Sep-2017
5-Nov-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 20-Nov -2017 at 18:50
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000837
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
12-Nov-2017*
D u ra tio n o f re a c tio n :
3 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the Vet, Daisy; 7 year 9 Month old, 37.1 Kg, female, desexed, Labarodor was given
PO one dosage form of NEXGARD CHEWABLES SPECTRA FOR DOGS 30.1-60 kg (150 mg Afoxolaner 30mg
Milbemycin, batch AB1596/16 and expiry 08/2019) for internal and external parasites on the 05th
of NOV 2017 by the owner. On the 13th of NOV, the dog was presented to the clinic as it had
developed a dry cough the previous night, on 13th was breathing heavily, gaggy and was unsteady
on hind legs. Physical examination found the dog was ambulatory with slight hind limb ataxia,
paresis (as had difficulty hopping into cage), was polypnoeic, panting, chest noisy from upper
respiratory turbulence but no fluid rales, blink and gag reflexes weak and an engorged tick was
See continuation page
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
13 NOV - Niramine (chlorpheniramine maleate 10mg/ml ) x 1.8 ml SC, Methadone 10mg/ml x 1.5ml
plus
Acepromazine 2% x .25 ml. Tick Anti Serum 36ml (warmed in 250ml 0.9% NaCL over 2.5 hours). Hair
clipped, Frontline spray (fipronil) applied to the head, tail and feet. Viscotears (polyacrylic
acid) was applied to the eyes. Fluid therapy of 0.9 % NaCl was started (running at 90ml/h, then
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
1
0
D a te w h e n :
15-Nov-2017
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): started on the 05th of SEP 2017
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product is labelled to kill >95% of paralysis ticks within 48 hours and to minimise the risk
of tick paralysis. However the label also states that treatment with the product alone will not
entirely remove the risk of tick paralysis. Daily searching for and removal of ticks is
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
* approximate
Version : 20-Nov -2017 at 18:50
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000837
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
CHEWABLE TABLETS
7. R EACT ION D AT A (continued)
Adverse Events
found on the right shoulder (over shoulder blade). Tick Toxicosis 2B grade was diagnosed.
Niramine (chlorpheniramine maleate 10mg/ml ) x 1.8 ml SC, Methadone 10mg/ml x 1.5ml plus
Acepromazine 2% x .25 ml were administered on admission. Tick Anti Serum 36ml (warmed in 250ml
0.9% NaCL over 2.5 hours). Hair clipped, Frontline spray (fipronil) applied to the head, tail and
feet, tick search was negative. Viscotears (polyacrylic acid) was applied to the eyes. Fluid
therapy of 0.9 % NaCl was started (running at 90ml/h, then reduced the rate to 65 ml/h
overnight). In the morning the next day, dog urinated in cage, QAR, breathing sedate and regular,
vitals WNL. The dog walked outside (slowly but good well balanced gait) but Gag was still not the
best. IVF continued and by evening the dog continued to gradually improve, breathing normal
(light pant), urinated on walk outside, gag reflex was quite good but the dog was not keen on
food or water. On 15th NOV – dog was BAR, walking normally, gag good, respiration ok, chest
clear, urinated on morning walk, ate food without difficulty and so was discharged. This is the
extent of the information available., (Outcome : Recovered)
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
reduced the rate to 65 ml/h overnight). 14th - fluid therapy continued.
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
recommended. There is no clear evidence that the product hasn't performed according to its label
claim for control of ticks. Assessed O1
Version : 20-Nov -2017 at 18:50
From:
S 47F
To:
AERP
Subject:
17AU000835 Nexgard AE
Date:
Tuesday, 21 November 2017 11:19:59 AM
Attachments:
image001.png
17AU000835 Nexgard AE.pdf
Dear S 47F
Please find attached details of a suspected lack of efficacy experience report following
administration of Nexgard Chewables for Dogs 4.1 - 10 kg (APVMA No. 67941).
The Merial reference number for this case is 17AU000835.
Please do not hesitate to contact us if anything further is required.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal
requirements and regulations, all adverse events (AE) are recorded. Collection of an AE report
does not constitute an admission that our product caused or contributed to the AE. Confounding
factors such as concurrently administered drugs, environmental factors, and medical history of
the animal must be considered when evaluating AE reports.
Kind regards,
S 47F
S 47F
Senior Regulatory Affairs Associate
Boehringer Ingelheim Animal Health
S 47F
cid:image001.png@01D362BA.277BF2F0
Making more health for patients, our people and our community.
This e-mail is confidential. If you are not the intended recipient you must not disclose or use the information contained in it. If you
have received this e-mail in error, please notify the sender immediately and then delete it. You should not copy, use, disclose or
distribute this e-mail without the author's permission. For general enquiries please call 1800 808 691.
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000837
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Attending Veterinarian
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
14-Nov-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Retriever Labrador
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
36.2
7.9 Year(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasiticide
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: unknown
NEXGARD SPECTRA XL; Dosage Form: Chewing tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 150 MG / MILBEMYCIN OXIME 30 MG
Unknown
B a tc h N o .: AB159616
E xp iry d a te :
S to ra g e d e ta ils:
31-Aug-2019
Unknown
T re a tme n t D e ta ils: Parasiticide
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
5-Sep-2017
5-Nov-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Version : 20-Nov -2017 at 18:50
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000837
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
12-Nov-2017*
D u ra tio n o f re a c tio n :
3 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the Vet, Daisy; 7 year 9 Month old, 37.1 Kg, female, desexed, Labarodor was given
PO one dosage form of NEXGARD CHEWABLES SPECTRA FOR DOGS 30.1-60 kg (150 mg Afoxolaner 30mg
Milbemycin, batch AB1596/16 and expiry 08/2019) for internal and external parasites on the 05th
of NOV 2017 by the owner. On the 13th of NOV, the dog was presented to the clinic as it had
developed a dry cough the previous night, on 13th was breathing heavily, gaggy and was unsteady
on hind legs. Physical examination found the dog was ambulatory with slight hind limb ataxia,
paresis (as had difficulty hopping into cage), was polypnoeic, panting, chest noisy from upper
respiratory turbulence but no fluid rales, blink and gag reflexes weak and an engorged tick was
See continuation page
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
13 NOV - Niramine (chlorpheniramine maleate 10mg/ml ) x 1.8 ml SC, Methadone 10mg/ml x 1.5ml
plus
Acepromazine 2% x .25 ml. Tick Anti Serum 36ml (warmed in 250ml 0.9% NaCL over 2.5 hours). Hair
clipped, Frontline spray (fipronil) applied to the head, tail and feet. Viscotears (polyacrylic
acid) was applied to the eyes. Fluid therapy of 0.9 % NaCl was started (running at 90ml/h, then
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
1
0
D a te w h e n :
15-Nov-2017
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): started on the 05th of SEP 2017
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product is labelled to kill >95% of paralysis ticks within 48 hours and to minimise the risk
of tick paralysis. However the label also states that treatment with the product alone will not
entirely remove the risk of tick paralysis. Daily searching for and removal of ticks is
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
* approximate
Version : 20-Nov -2017 at 18:50
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000837
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Active substance(s) (INN) - continued
CHEWABLE TABLETS
7. R EACT ION D AT A (continued)
Adverse Events
found on the right shoulder (over shoulder blade). Tick Toxicosis 2B grade was diagnosed.
Niramine (chlorpheniramine maleate 10mg/ml ) x 1.8 ml SC, Methadone 10mg/ml x 1.5ml plus
Acepromazine 2% x .25 ml were administered on admission. Tick Anti Serum 36ml (warmed in 250ml
0.9% NaCL over 2.5 hours). Hair clipped, Frontline spray (fipronil) applied to the head, tail and
feet, tick search was negative. Viscotears (polyacrylic acid) was applied to the eyes. Fluid
therapy of 0.9 % NaCl was started (running at 90ml/h, then reduced the rate to 65 ml/h
overnight). In the morning the next day, dog urinated in cage, QAR, breathing sedate and regular,
vitals WNL. The dog walked outside (slowly but good well balanced gait) but Gag was still not the
best. IVF continued and by evening the dog continued to gradually improve, breathing normal
(light pant), urinated on walk outside, gag reflex was quite good but the dog was not keen on
food or water. On 15th NOV – dog was BAR, walking normally, gag good, respiration ok, chest
clear, urinated on morning walk, ate food without difficulty and so was discharged. This is the
extent of the information available., (Outcome : Recovered)
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
reduced the rate to 65 ml/h overnight). 14th - fluid therapy continued.
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
recommended. There is no clear evidence that the product hasn't performed according to its label
claim for control of ticks. Assessed O1
Version : 20-Nov -2017 at 18:50
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000792
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Other
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
5-Nov-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r: Other
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 1
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Great Dane
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
26
15 Week(s) *
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
See continuation page
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67939
NEXGARD CHEWABLES FOR DOGS 25.1-50 KG; Dosage Form: Tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 136 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: UNKNOWN
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Other
29-Oct-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Exelpet Vet Series Spot on Unk. UNKNOWN Topical / 1 dosage form per 1 animal,
Flea Treatment (fipronil) Cutaneous Flea and Tick Treatment, (26-
Oct-2017)
Unknown flea shampoo Unk. Unk. Topical / per Unknown, 0 Day(s), (29-
treatment Cutaneous Oct-2017)
* approximate
Version : 13-Nov -2017 at 01:02
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000792
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
1-Nov-2017
D u ra tio n o f re a c tio n :
2 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
Adverse Events
As reported by the breeder, Lava; approx. 15 week old, 26 Kg, male, intact Great Dane was given
PO one dosage form of NEXGARD CHEWABLES FOR DOGS 25.1-50 kg (136 mg Afoxolaner, batch and expiry
unknown) for flea and tick control on the 29th of OCT 2017 by the breeder. The dog was fine
untill the 1st of NOV 2017, when the dog experienced inappetance and was lethargic. Vet attention
was sought and the dog was soon after euthanised. The breeder had used Exelpet Vet Series Spot on
Flea Treatment (fipronil) on the 26th of OCT and an unknown flea shampoo treatment on the 29th of
OCT. This is the extent of the information available., (Outcome : Euthanasia)
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
Unknown treatment.
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
1
0
0
0
0
0
D a te w h e n :
3-Nov-2017*
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s):
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
Although inappetance and lethargy have been very rarely reported temporal to use of isoxazoline
class products, the time to onset is longer than expected. Additionally these signs are generally
self-limiting and of short duration, not progressing to systemic illness warranting euthanasia.
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
* approximate
Version : 13-Nov -2017 at 01:02
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000792
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
No other etiologic agent has been identified and the data available is insufficient to draw any
causality conclusion. Assessed O1.
Version : 13-Nov -2017 at 01:02
From:
S 47F
To:
AERP
Subject:
Suspected Adverse Event Reports
Date:
Monday, 13 November 2017 5:29:14 PM
Attachments:
image001.jpg
17AU000792_Nexgard.pdf
17AU000824_Nexgard.pdf
S 22
Dear S 47F
Please find attached the following adverse event reports:
· 17AU000792 – Nexgard Chewables for Dogs
· S 22
· 17AU000824 – Nexgard Chewables for Dogs
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and regulations,
all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission that our product caused or
contributed to the AE. Confounding factors such as concurrently administered drugs, environmental factors, and medical
history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Boehringer Ingelheim Animal Health
Level 1, 78 Waterloo Road, North Ryde NSW 2113, Australia
S 47F
Email_Signature_600px_FINAL
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000824
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Attending Veterinarian
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
9-Nov-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Border Collie
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
3.8
8 Week(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Parasite control
6. PR OD U CT D AT A # 1
See continuation page
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67941
NEXGARD CHEWABLES FOR DOGS 4.1-10 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 28.3 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: Unknown
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Parasite control
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
7-Nov-2017
0 Day(s)
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Overdose
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
Milbemax Dog Tablet (0.5- Unk. Unk. PO-Oral 1 Tablets per 1 animal,
5kg) (milbemycin oxime) Parasite control, 0 Day(s),
(7-Nov-2017)
Version : 13-Nov -2017 at 01:22
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000824
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
8-Nov-2017
D u ra tio n o f re a c tio n :
Unknown
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the veterinarian, Rocket, a 2 month old male desexed 3.8kg Border collie received
one dosage form of NEXGARD CHEWABLES FOR DOGS 4.1-10KG (AFOXOLANER 28.3 MG CHEWABLE TABLETS,
unknown batch and expiry) administered by the veterinarian for internal and external parasite
control on 7 NOV 2017. Please note that this was an off label use of the product as the dog was
slightly overdosed for his weight. He also received a Milbemax tablet (dog 0.5-5kg) (milbemycin
oxime) for internal parasites at the same time. 8 NOV 2017 he was noted to be lethargic from 2pm,
increased drinking. 10pm he had a siezure lasting one minute. Was treated with Keppra
(levetiracetam), antibiotics, oxygen, lactulose and IV fluids. Bloods revealed a very mild
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
Keppra (levetiracetam), antibiotics, oxygen, lactulose and IV fluids
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
0
1
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Unknown
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e : Unknown
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
P o ssib le
R e a so n fo r c la ssific a tio n :
See continuation page
The chronology of the onset of the AE is consistent with the pharmacological profile of the
product. Lethargy, emesis and seizure have very rarely been reported temporal to product use
however polydipsia, anaemia, leukocytosis and raised GGT are unexpected. Other factors may have
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 13-Nov -2017 at 01:22
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000824
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
7. R EACT ION D AT A (continued)
Adverse Events
leukocytosis (due to lympho- and monocytosis), mild anaemia, increased GGT. 11pm another seizure
with vomiting. 9 NOV 2017 was discharged on owners request. 10 NOV 2017 back to normal bar some
mild unsteadiness after running around. This is the extent of the information available,
(Outcome : Unknown)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
contributed to the AE or its severity including incorrect use of product for weight, and
concurrent product administration. Assessed B.
Version : 13-Nov -2017 at 01:22
From:
S 47F
To:
AERP
Subject:
17AU000804 Nexgard LOE
Date:
Monday, 13 November 2017 11:00:26 AM
Attachments:
image007.png
17AU000804 Nexgard LOE.pdf
Dear S 47F
Please find attached details of a suspected lack of efficacy experience report following
administration of Nexgard Chewables for Dogs 25.1 - 50 kg (APVMA No. 67939).
The Merial reference number for this case is 17AU000804.
Please do not hesitate to contact us if anything further is required.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal
requirements and regulations, all adverse events (AE) are recorded. Collection of an AE report
does not constitute an admission that our product caused or contributed to the AE. Confounding
factors such as concurrently administered drugs, environmental factors, and medical history of
the animal must be considered when evaluating AE reports.
Kind regards,
S 47F
S 47F
Senior Regulatory Affairs Associate
Boehringer Ingelheim Animal Health
S 47F
Making more health for patients, our people and our community.
This e-mail is confidential. If you are not the intended recipient you must not disclose or use the information contained in it. If you
have received this e-mail in error, please notify the sender immediately and then delete it. You should not copy, use, disclose or
distribute this e-mail without the author's permission. For general enquiries please call 1800 808 691.
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000804
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Attending Veterinarian
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
7-Nov-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
Mixed Mastiff
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r: Unknown
W e ig h t (k ilo s):
A g e :
14.62
8 Month(s) *
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67939
NEXGARD CHEWABLES FOR DOGS 25.1-50 KG; Dosage Form: Tablet
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 136 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: ABA143116
E xp iry d a te :
S to ra g e d e ta ils:
31-Jul-2018
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
Unknown
19-Oct-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Overdose, Treatment / vaccination program
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
* approximate
Version : 12-Nov -2017 at 18:51
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000804
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
28-Oct-2017
D u ra tio n o f re a c tio n :
2 Day(s)
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the vet, Cindy; a 8 Month old (approx.), 14.62 Kg, female, mastiff cross was given
PO one dosage form of NEXGARD CHEWABLES FOR DOGS 25.1 -50kg (136mg Afoxolaner, batch
ABA1431/16and expiry 07/2018) for flea and tick control on the 19th of OCT 2017 by the owner. On
the 28th of OCT, the owner noticed the dog was quite wobbly, retched, regurgitated and found a
paralysis tick on the left side of her neck. Vet attention was sought and on physical
examination, dog was found to be eupnoeic (but stertorous breathing and retching prior to
presentation), mildly ataxic, with occasional knuckling and crossing over of front limbs,
swallowing reflexes appeared weak and a moderately sized engorged paralysis tick was removed from
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
Tick anti serum administered IV (15 ml diluted) and an ectoparasiticide bath
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
1
0
D a te w h e n :
30-Oct-2017
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): Unknown
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e : Unknown
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product is labelled to kill >95% of paralysis ticks within 48 hours and to minimise the risk
of tick paralysis. However the label also states that treatment with the product alone will not
entirely remove the risk of tick paralysis. Daily searching for and removal of ticks is
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 12-Nov -2017 at 18:51
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000804
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
6. PR OD U CT D AT A (continued)
Product data #1 continued
Use according to label - continued
not respected
7. R EACT ION D AT A (continued)
Adverse Events
the left side of the neck. The tick was alive but its movement was not vigorous. Diagnosed with
paralysis tick toxicity grade 1A. IV catheter placed, Tick anti serum administered IV (15 ml
diluted) and an ectoparasiticide bath was also given. The dog was hospitalised and as was still
retching/gagging the next day, was hospitalised for another day. It was discharged on the 30th as
all signs had resolved. It should be noted that the NEXGARD used was not recommended for the dogs
weight range. This is the extent of the information available., (Outcome : Recovered)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
recommended. There is no clear evidence that the product hasn't performed according to its label
claim for control of ticks. Assessed O1
Version : 12-Nov -2017 at 18:51
From:
S 47F
To:
AERP
Subject:
RE: Nexgard - 17AU000790
Date:
Friday, 10 November 2017 5:41:43 PM
Attachments:
image001.jpg
17AU000790_Nexgard.pdf
Hi S 47F
Please find attached a suspected adverse event report for Nexgard Chewables for Dogs.
Merial is now part of Boehringer Ingelheim. In accordance with global company policy, legal requirements and
regulations, all adverse events (AE) are recorded. Collection of an AE report does not constitute an admission
that our product caused or contributed to the AE. Confounding factors such as concurrently administered drugs,
environmental factors, and medical history of the animal must be considered when evaluating AE reports.
Kind regards
S 47F
Regulatory Affairs Manager
Merial Australia Pty Ltd – Merial is now part of Boehringer Ingelheim
Level 1, 78 Waterloo Rd, North Ryde, NSW 2113, Australia
S 47F
www.boehringer-ingelheim.com.au
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 1 of 3
17AU000790
S a fe ty issu e s
in a n ima ls
in h u ma n s
R e p o rtin g c o u n try:
Australia
L a c k o f e xp e c te d e ffic a c y
P u rc h a se c o u n try:
Australia
W ith d ra w a l p e rio d issu e s
R e p o rt so u rc e :
E n v iro n me n ta l p ro b le ms
Owner
1. AD D R ESS OF COMPET EN T AU T H OR IT Y
2. N AME AN D AD D R ESS OF SEN D ER
Adverse Experience Reporting Program
Merial Australia Pty Ltd
Australian Pesticides and Veterinary
Building D, 12-24 Talavera Road
Medicines Authority
Macquarie Park
PO Box E240
New South Wales
Kingston ACT 2604
2113, Australia
D a t e c o m p la in t re c e iv e d b y s e n d e r:
2-Nov-2017
(d d -M o n -yyyy)
T yp e o f re p o rt
In itia l
Fo llo w -u p
(d a te , c a se n u mb e r)
P e rso n w h o re p o rte d th e re a c tio n : v e te rin a ria n
o w n e r
p h ysic ia n
p h a rma c ist
o th e r:
3. VET ER IN AR IAN / PH YSICIAN / PH AR MACIST
4. AN IMAL OW N ER / H U MAN PAT IEN T
N a me :
N a me :
A d d re ss:
A d d re ss:
Withheld
Withheld
T e le p h o n e N o .
T e le p h o n e N o .
5. AN IMAL D AT A
N o . o f a n im a ls t re a t e d : 1
N o . o f a n im a ls s h o w in g s ig n s : 1
N o . o f a n im a ls d ie d : 0
A n ima l c h a ra c te ristic s (a n ima l(s) sh o w in g sig n s):
S p e c ie s:
B re e d / p ro d u c tio n typ e :
Canine
German Shepherd Dog
S e x/ p h ysio lo g ic a l sta tu s:
fe ma le
ma le
p re g n a n t
n e u te re d
la c ta tin g
o th e r:
W e ig h t (k ilo s):
A g e :
20 *
18 Month(s)
S ta te o f h e a lth a t time o f tre a tme n t:
g o o d
fa ir
p o o r
c ritic a l
u n k n o w n
R e a so n (s) fo r tre a tme n t (p re v e n tio n a g a in st w h a t d ise a se (s) o r in itia l d ia g n o sis):
Flea and Tick Treatment
6. PR OD U CT D AT A # 1
T ra d e n a me (in c lu d e d o sa g e fo rm a n d stre n g th ):
M .A . n u mb e r: 67940
NEXGARD CHEWABLES FOR DOGS 10.1-25 KG
A c tiv e su b sta n c e (s) (IN N ):
A T C v e t c o d e :
AFOXOLANER 68 MG CHEWABLE TABLETS
QP53BX04
B a tc h N o .: Unknown
E xp iry d a te :
S to ra g e d e ta ils:
Unknown
Unknown
T re a tme n t D e ta ils: Flea and Tick Treatment
D o se / fre q u e n c y:
R o u te / site o f a d min istra tio n :
1 dosage form per 1 animal
PO-Oral
S ta rt d a te o f tre a tme n t:
S to p d a te o r d u ra tio n :
W h o a d min iste re d th e p ro d u c t:
Animal Owner
21-Oct-2016*
21-Oct-2017
v e te rin a ria n
o w n e r
o th e r
U se a c c o rd in g to la b e l:
ye s
u n k n o w n
n o
e xp la in :
Unknown
A c tio n ta k e n a fte r re a c tio n :
d ru g w ith d ra w n
d o se re d u c e d
o th e r
Had already been completed
D id re a c tio n a b a te a fte r sto p p in g d ru g ?
ye s
n o
n o t a p p lic a b le
D id re a c tio n re a p p e a r a fte r re in tro d u c tio n ?
ye s
n o
n o t a p p lic a b le
L ist a ll o th e r re le v a n t me d ic a tio n s g iv e n to a n ima l(s):
P ro d u c t n a me /
Co mp a n y
B a tc h N o .
R o u te a n d site o f
D o se , fre q u e n c y, in d ic a tio n , d u ra tio n o f
a d min
tre a tme n t (d a te s o f b e g in n in g a n d e n d )
* approximate
Version : 10-Nov -2017 at 01:31
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 2 of 3
17AU000790
7. R EACT ION D AT A
D a te o f o n se t o f u n e xp e c te d sig n s:
2-Nov-2017
D u ra tio n o f re a c tio n :
Ongoing
D e sc rib e th e se q u e n c e o r e v e n ts in c lu d in g a d min istra tio n o f p ro d u c t(s), a ll c lin ic a l sig n s, site o f re a c tio n , se v e rity,
p e rtin e n t la b te sts, n e c ro p sy re su lts, p o ssib le c o n trib u tin g fa c to rs (if n e c e ssa ry u se e xtra sh e e t):
See continuation page
Adverse Events
As reported by the owner; Maya, an 18 Month old, approx. 20Kg, female, desexed German Shepherd
was given PO one dosage form of NEXGARD CHEWABLES FOR DOGS 10.1-25 kg (68 mg Afoxolaner, batch
and expiry unknown) by the owner for flea and tick control intermittently over the past 12 months
with the most recent dose on the 21th of OCT 2017. On the 2nd of Nov, the dog started to show
signs of paralysis. Vet attention was sought and the dog was hospitalised and treated with
Frontline spray, tick anti serum, fluids and sedation and metoclopramide.No ticks were found but
possible tick attachment sites (3 tick craters - one on caudal L ear, and two on underside of
jaw) were found. Assessed by the vet as 3A tick paralysis (sternally recumbent with good
W e re th e u n e xp e c te d sig n s tre a te d ? If ye s, g iv e th e d e ta ils o f tre a tme n t in c lu d in g p ro d u c t(s) u se d :
Frontline spray, tick anti serum, fluids and sedation, metclopramide and hospitalisation
O u tc o me o f re a c tio n to d a te :
K ille d / e u th a n ise d
d ie d
u n d e r tre a tme n t
a liv e w ith se q u e la e
re c o v e re d
u n k n o w n
N o o f a n ima ls:
0
0
0
0
0
1
D a te w h e n :
8. AT T EN D IN G VET ER IN AR IAN 'S LEVEL OF SU SPICION T H AT D R U G CAU SED
p o ssib le
u n lik e ly
n o a tte n d in g v e t
U n k n o w n
9. PR EVIOU S EXPOSU R E AN D R EACT ION (S) T O PR OD U CT (S)
P re v io u s e xp o su re to th e su sp e c t p ro d u c t?
n o
ye s
D a te (s): on and off for the last 12 months
P re v io u s re a c tio n to th e su sp e c t p ro d u c t?
n o
ye s
D e sc rib e :
D e -c h a lle n g e in fo rma tio n : Unknown
10. D ET AILS OF SU SPECT ED AD VER SE R EACT ION (S) IN H U MAN S
P a tie n t d e ta ils S e x:
P re g n a n t
A g e / d a te o f b irth :
O c c u p a tio n (if re le v a n t):
Unknown
Unknown
Unknown
D a te o f e xp o su re :
D a te o f re a c tio n :
Unknown
Unknown
N a tu re a n d d u ra tio n o f e xp o su re , re a c tio n d e ta ils (in c lu d in g symp to ms) a n d o u tc o me :
Unknown
11. CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
A (p ro b a b le )
B (p o ssib le )
O (u n c la ssifie d )
O 1 (in c o n c lu siv e )
N (u n lik e ly)
In c o n c lu siv e
R e a so n fo r c la ssific a tio n :
See continuation page
The product is labelled to kill >95% of paralysis ticks within 48 hours and to minimise the risk
of tick paralysis. Treatment with the product alone will not entirely remove the risk of tick
paralysis, no new ticks were found, and the dog did not respond to appropriate tick paralysis
11. AU ST R ALIAN CAU SALIT Y ASSESSMEN T
Cla ssific a tio n :
P ro b a b le
P ro b a b le / O ff L a b e l
P o ssib le
P o ssib le / O ff L a b e l
U n lik e ly
R e a so n fo r c la ssific a tio n :
Unknown
Version : 10-Nov -2017 at 01:31
Attachments included
Reports to f ollow
VETERINARY PHARMACOVIGILANCE
R E P OR T FOR S U S P E CT E D AD V E R S E R E ACT ION S IN AN IMALS OR IN H U MAN S
AFT E R T H E U S E OF A V E T E R IN AR Y ME D ICIN E
SEN D ER R EPOR T ID EN T IFICAT ION -CASE R EF.N o: Page 3 of 3
17AU000790
12. OVER ALL CAU SALIT Y ASSESMEN T R ELAT ED T O ALL SU SPECT ED PR OD U CT S
FOR COMPET EN T AU T H OR IT Y U SE ON LY
N a me a n d title o f p e rso n re sp o n sib le fo r th e a c c u ra c y o f th e in fo rma tio n
S ig n a tu re
D a te
A tta c h me n ts in c lu d e d
R e p o rts to fo llo w
7. R EACT ION D AT A (continued)
Adverse Events
respiratory score) but stated that with no new found ticks that this could also be due to another
cause (toxin, snake bite or spinal disease etc). Treated for 4 days with no real change in status
(still recumbent) which is unusual for tick paralysis - vet recommended further work up for snake
envenomation, polyradiculoneuritis, botulism or other causes. Owner elected home nursing. This is
the extent of the information available., (Outcome : Ongoing)
11. CAU SALIT Y ASSESSMEN T (continued)
R e a so n fo r c la ssific a tio n :
treatment. There is no clear evidence that the product hasn't performed according to its label
claim for control of ticks and other causes remain plausible. Case assessed O1 - inconclusive.
Version : 10-Nov -2017 at 01:31
Document Outline
