FDA will remove warning language on drugs for smoking cessation

The Food and Drug Administration (FDA) last week announced it will remove warning language about serious mental health side effects from the labels for the smoking cessation drugs varenicline (Chantix) and bupropion (Zyban), after concluding from results of a major trial that the medications' benefits outweigh their risks.

The FDA will remove a boxed warning from the Chantix label and will eliminate language on serious mental health side effects in patients quitting smoking from the boxed warning on the Zyban label. The labeling language had been added in 2009.

In the comprehensive Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES), risk of serious side effects from the two drugs on mood, behavior or thinking was found to be lower than previously believed, and generally was most prominent in patients already being treated for psychiatric illness. “The results of the trial confirm that the benefits of stopping smoking outweigh the risks of these medicines,” last week's FDA safety announcement stated.

The randomized, placebo-controlled EAGLES study examined the risk of clinically significant neuropsychiatric adverse events in individuals using varenicline, bupropion or nicotine replacement therapy. A statement from Pfizer, maker of Chantix, says that additional labeling revisions for its product will include information on its greater efficacy compared with bupropion or the nicotine patch.

The FDA announcement does advise patients to stop taking Chantiz or Zyban and to contact their healthcare provider if they experience any side effects in mood, behavior or thinking.