MONDAY, Feb. 4 (HealthDay News) -- The U.S. Food and Drug Administration has issued a Public Health Advisory to inform the public about a potential risk of serious neuropsychiatric symptoms associated with the smoking cessation drug Chantix (varenicline).
The advisory follows postmarketing adverse event reports linking Chantix to changes in behavior, agitation, depressed mood, and suicidal ideation and behavior. After reviewing the data, the FDA has requested that Pfizer, the maker of Chantix, include more prominent warnings of these neuropsychiatric symptoms on the drug's labeling.
Chantix, which acts on nicotine receptors in the brain, was approved by the FDA in May 2006 as a smoking cessation aid. The FDA encourages patients to discuss these new safety concerns with their doctors, and recommends that health care professionals closely monitor their patients who are taking Chantix for behavior and mood changes.
"Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product," said Bob Rappaport, M.D., director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products. "While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks."
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