US Pharm. 2008;33(3):84.
Reacting to emerging evidence of a link between the smoking cessation drug Chantix (varenicline) and serious neuropsychiatric symptoms, the FDA issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings. As a result, FDA has requested that Chantix's manufacturer, Pfizer, more prominently highlight this safety information in the drug's prescribing information. The agency is also working with Pfizer to finalize a patient Medication Guide.
Last fall, the agency said that it was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
"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," saidÜBob Rappaport, MD, director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products.
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