Health
FDA concerned over anti-smoking drug
NEWS IN BRIEF — Posted Dec. 17, 2007
The Food and Drug Administration is calling for physicians to monitor patients who start taking varenicline (Chantix) for adverse behavior and mood changes, according to an FDA statement last month.
The agency acted following reports supplied by the drug's manufacturer, Pfizer Inc., of patients who developed suicidal thoughts and actions. Some also reportedly became erratic, aggressive or drowsy, and the FDA is warning patients who begin taking this medication to use caution when driving or operating machinery.
Varenicline is mainly prescribed for smoking cessation, and some of the reported symptoms also may be caused by nicotine withdrawal. The agency's Center for Drug Evaluation and Research is reviewing available data to determine the magnitude of the medication's role in the reported events.
The FDA requests that additional incidents associated with varenicline be reported to the MedWatch Adverse Event Reporting program.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/12/17/hlbf1217.htm.
