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Chantix under FDA Scanner for Skin Reactions and Accidents

June 08, 2009

Pfizer’s highly ambitious anti- smoking drug Chantix is in trouble once again. Chantix, which was previously linked to an increased risk of suicide and suicidal behavior, was listed on a report released Thursday by the FDA of medications they are currently investigating for potential signals of new serious risks. Chantix has been listed in 19 drugs or classes of medications identified by the FDA that showed potential signs of safety issues in the Adverse Event Reporting System (AERS) between October 2008 and December 2008.

Side effects of Chantix are being examined for a possible increased risk of angiodema, serious skin reactions, visual impairment and accidental injury. The FDA indicates that they are evaluating these issues to determine whether there is any need for regulatory action, such as stronger warnings.

Chantix, which is manufactured by Pfizer, was approved by the FDA in May 2006 and quickly showed signs of becoming a potential blockbuster medication. Early last year, sales slowed substantially after Chantix side effects were linked to a high number of suicides, suicide attempts and other reports of unusual aggressive behavior.