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.