FDA reviewing Pfizer anti-smoking drug

See below article for some more review on Champix/Chantix)

Personally, The drug has worked for me and I did not really suffer any ill effects (apart from the dreams which I still miss a lot !) I know others were not so lucky. Like any drug however, one should be aware of the potential risks. I for one decided that the risks on continuing to smoke far outweighed the ones from taking it. But this is me speaking only.


FDA reviewing Pfizer anti-smoking drug

Tue May 27, 2008

SILVER SPRING, Maryland (Reuters) - The Food and Drug Administration is taking a closer look at Pfizer Inc's anti-smoking drug Chantix after reports of hundreds of patients experiencing serious problems, an agency official told Reuters on Tuesday.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the agency is reviewing all the reported cases. "We're are looking at them, but it takes awhile," she said in an interview.

The drug, which aims to help smokers quit their habit in part by mimicking some of nicotine's effects, has already been linked to psychiatric side effects such as depression and suicide.

But U.S. researchers at the nonprofit Institute for Safe Medication Practices and Wake Forest University last week found hundreds of reported cases of accidents, heart trouble, vision loss and other problems with Chantix since its 2006 approval.

FDA's Woodcock said the agency does not yet know whether the drug directly caused the complications cited in the researchers' report. Agency scientists are in the process of sorting through the cases, she added.

It was not clear how long it would take the agency to take any action. Woodcock said agency staffers would need time to do their work.

"We are not able to put the amount of resources against this we would need to do it in a very prompt matter," she said.

Pfizer officials have defended Chantix, a key drug for the drugmaker that has touted its potential to generate new revenue, but prescriptions for the drug have been declining, according to some ****ysts.

A representative for Pfizer could not be immediately reached for comment.

Shares of Pfizer were down more than 1 percent, or 27 cents, at $19.26 in early afternoon trading on the New York Stock Exchange.

(Additional reporting by Lisa Richwine; editing by John Wallace and Gerald E. McCormick)

3 Replies

  • newsblogs.chicagotribune.co...

    Please note that I am not in the business of scaremongering. I have been on Champix (which I still think was a key factor in my quit) and have been trying to gather information ever since I decided to take the drug. As it is so new, the information is still very sketchy.

    Personally I always felt there were risks, as with any drug. For me the benefits of quitting outweighed those of continuing to smoke. I also believe that some of those side effects are more likely to be due to the smoking cessation and its psychological effects rather than the drug itself. Again - this is my personal view, I am not a medical practitioner...

  • difficult one - however i took zyban last time nd it made my face tingle for a week!! i had no side effect with champix - other than giving up smoking ;) but then again i didnt take it for long, my friend didnt do so well on it and had to stop. Years ago i had contraception rods in my arm, absolutely bloody wonderful had to come out after 5 years when i found they had been taken off the market as so many (U.S) lawsuits! so i hd to find something else ( some still call me mrs bobitt)

    Every one is different, we have to take our own risks, and only we know our own bodies.

    did that make sense - prob not, hey ho


  • I took champix Jan/Feb this year and had one heck of a job getting my doctor to precribe it, intitially I had to buy the drug via one of the online drugstores.

    For me it was and always will be a wonderdrug, but I do wonder if there are quitters that buy this drug in desperation without theirs doctors backup who are probably not suitable due to other medication/health reasons. I have even seen champix advertised on ebay in the past - albeit it does get removed pretty quickly due a per ebay rules.

    Thanks for posting anyway - makes people aware that there are many side effects to be considered.

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