Those who have reported Adverse Effects to CHAMPIX

Rod Hamblin (Account suspended) made this Freedom of Information request to Therapeutic Goods Administration

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

Response to this request is long overdue. By law, under all circumstances, Therapeutic Goods Administration should have responded by now (details). You can complain by requesting an internal review.

Rod Hamblin (Account suspended)
Sent

Dear Therapeutic Goods Administration,

I made a request for 24 names & contact details of those who made an adverse reaction report to the ADR.

I still haven't received an answer to my request

Yours faithfully,

Rod Hamblin

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TGA FOI,

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    New FOI request from Rod Hamblin FOI 039 1516 SEC UNCLASSIFIED.html

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Dear Mr Hamblin

I attach the correspondence sent to you in September 2015 in relation to your invalid FOI request.

Please don't hesitate to contact me should you wish to discuss further.

Kind regards
Liz

Elizabeth Santolin
Freedom of Information Team
Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch

Phone: (02) 6232 8664
Email: [email address]

Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606
www.tga.gov.au

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Kristof Wing left an annotation ()

Hey Rod,

I appreciate what you are trying to do here are would like help you!

It looks like you're after information relating to adverse events related to varenicline.

The best you're going to do in this case is get the de-identified information about adverse events.
The people at the FOI office of the TGA are really great to work with and generally they will fulfil all reasonable requests.

It might be worthwhile to start broad and then narrow you request accordingly, if it is deemed to be too much work or you find it too expensive.

I would recommend that you start by asking for summary data relating to all adverse events for varenicline (if available), when it was prescribed under the indication of smoking cessation. This will give you a good idea of where the events lie.
Then, you could request further information about specific event categories (i.e. deaths and suicides), and see if case reports (de-identified) would be made available.

What specific purpose do you have for this request? Maybe I can be of more help then.

Feel free to email me privately, too.
Alternatively you can Direct Message me on Twitter.

Best wishes,
Kristof

--
Kristof Wing
Email: kristof.wing@gmail.com
Twitter: @Yunadal

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