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Popular Stop-Smoking Drugs to Carry Mental Health Risk Warnings

Posted Jul 08 2009 10:55am

By Todd Neale, Staff Writer, MedPage Today

By Todd Neale, Staff Writer, MedPage Today

The FDA said it will immediately require boxed warnings about the risk of serious neuropsychiatric symptoms on the packaging of two popular smoking cessation drugs, — varenicline (Chantix) and bupropion (Zyban, Wellbutrin, and generics).

Reports of behavioral changes, depressed mood, agitation, hostility, and suicidal thoughts and behavior associated with use of the drugs have been submitted to the FDA’s adverse event reporting system.

Throughout the marketing history of the drugs, there have been 98 suicides and 188 attempted suicides in varenicline users and 14 suicides and 17 attempted suicides in bupropion users, the agency reported.

The FDA is not recommending discontinuation of the medications, which have been shown effective for quitting smoking, according to Curtis Rosebraugh, MD, director of the agency’s Office of Drug Evaluation II.

But the FDA is recommending that clinicians monitor their patients for neuropsychiatric symptoms after initiating treatment.

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