July 01, 2009

Chantix, Zyban, Wellbutrin To Get Black Box Warning On Behavior Changes, Suicidality

This should come as no surprise to anyone, but today the FDA announced that it would require a new black box warning on certain smoking-cessation drugs, namely Chantix and Zyban, and would extend the warning to Wellbutrin (Zyban's name as an anti-depressant) and generic versions of Wellbutrin known as buproprion. The warning will notify patients and doctors of the risk of serious changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

"[FDA safety chief] Woodcock said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. She added that patients should immediately contact their health care professional if they experience such changes.

"The FDA’s request for the additional warnings is based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

"The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped."

Chantix has been in the news for much of the last two years for causing severe behavior changes and even suicides in some people taking the drug (my Chantix back catalog is here), all of which served to dramatically reduce sales of the drug despite a huge advertising campaign by its maker, Pfizer. Since it's an anti-depressant and already carries a black box warning on suicidality like all anti-depressant must, Wellbutrin's warning is likely a small change to extant warnings.

Posted by Philip Dawdy at July 1, 2009 10:21 AM
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Comments

I guess this new Black Box warning for the antidepressant Wellbutrin will now include suicidality for adults also instead of just for those 24 and under.

Posted by: Rosie at July 1, 2009 02:49 PM

People purchase drugs blindly without taking into consideration their side effects. Especially drugs for anxiety and diet pills should be taken only with the advice of a doctor.

Posted by: Vivian at July 6, 2009 09:59 PM

It's odd that no news articles I've read on this subject has mentioned the huge disparity between the two drugs. Zyban has been on the market for, what, ten years? fifteen years? And, according to USA Today, there have been 17 reported suicide attempts and 14 suicides (these numbers also include bupropion prescriptions, presumably for depression and not for smoking cessation). Chantix has been on the market for three, and has 98 reported suicides and at least 188 reported suicide attempts (this number varies from source to source -- some stories have reported as high as 400). Most news sources have noted the differing numbers, but the significant difference in the time period in which these reports have taken place seems to be overlooked. Not that such side effects are OK in any quantity, but it just seems to me that equating the two downplays how demonstrably dangerous Chantix has proven in a very short time.

Posted by: DR at July 7, 2009 06:57 AM

I agree with the above DR, assuming that is for doctor. Chantix is far more dangerous and can be studied as a cause of mental illness. The actions of the drugs are far different. It almost seems as if the FDA is showing partiality to Pfizer and continuing to try and down play the stronger signals the real numbers show. I had used them all but only chantix nearly cost me my life. Pfizer is still not answering questions either so what sort of support do those injured have?

Posted by: Virginia at July 29, 2009 01:28 PM
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