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Chantix Appears In Fda’s Safety Signal List

June 20, 2009

Safety signals that range from heart attacks and psychiatric events to skin reactions for 19 drugs or classes of drugs appear on a list the FDA derived from the adverse event reporting system for the final quarter of 2008. One prominent product that appears on the “Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System” list is Pfizer’s stop-smoking product Chantix (varenicline tartrate), due to safety signals concerning angioedema, serious skin reactions, visual impairment and accidental injury. The FDA says it is continuing to evaluate these issues to determine the need for any regulatory action.