July 1, 2009

FDA to require warnings for Chantix, Zyban

The U.S. Food and Drug Administration announced Wednesday it will require a boxed warning for the smoking cessation drugs Chantix and Zyban.

The FDA said the boxed warning -- the strongest warning the agency can require -- will appear on the package insert. It will highlight the risk of serious mental health events, including changes in behavior, depressed mood, hostility and suicidal thoughts when taking the drugs.

The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking, said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. 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.

Similar information on mental health events will be required for buproprion, marketed as the antidepressant Wellbutrin and for generic versions of buproprion. Those drugs already carry a boxed warning for suicidal behavior in treating psychiatric disorders.

Woodcock said healthcare professionals who prescribe Chantix (varenicline) and Zyban (buproprion) should monitor their patients for unusual changes in mood or behavior after starting the drugs. She added patients should immediately contact their healthcare professional if they experience such changes.

Chantix is manufactured by Pfizer Inc. Zyban is manufactured by GlaxoSmithKline.