Wednesday, July 1, 2009

FDA: Boxed warning for Chantix and Zyban

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

The FDA press release has this comment from Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research: “The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking... Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit.”

Wellbutrin (another branded name of bupropion) and generic versions of bupropion will also require this warning. Chantix is marketed by Pfizer and Zyban is marketed by GlaxoSmithKline (GSK). Before we know it, every drug out there will have a black box warning and people might simply start to ignore them. Will we soon need another form of a boxed warning?

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