FDA Calls for Chantix, Zyban to Feature Boxed Warning

Additional warnings follow reports of behavioral changes, depression, thoughts of suicide
By Eric Metcalf
HealthDay Reporter

WEDNESDAY, July 1 (HealthDay News) -- Prescribing information for the smoking cessation drugs varenicline (Chantix) and buproprion (Zyban) must feature a boxed warning that discusses potentially serious mental health changes linked to the drugs, according to an announcement July 1 from the U.S. Food and Drug Administration.

Analysis of reports submitted to the FDA's adverse event reporting system revealed cases of unusual behavior change, new or worsening depression, and thoughts of suicide or dying among individuals taking Chantix or Zyban. In many cases, the symptoms started soon after initiating the medication and stopped when the medication was halted.

Buproprion -- marketed as Wellbutrin, an antidepressant, or available in generic form -- will contain similar warnings. The FDA recommends that clinicians prescribing Chantix or Zyban should monitor patients for unusual mood or behavior changes after they begin the medications, and patients should contact their health care provider if they notice these changes.

"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," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research in Silver Spring, Md., in a prepared statement.

FDA News Release

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