FAA bans anti-smoking drug Chantix for pilots, air controllers

May 27, 2008

The FAA has banned anti-smoking drug Chantix for pilots and air controllers over safety concerns.

The Federal Aviation Administration has banned pilots and air traffic controllers from using the anti-smoking drug Chantix (varenicline, Pfizer) after a study found that it had apparently contributed to auto accidents and other problems that pose risks to both users and others. The aviation agency had approved the drug last summer, before federal safety regulators began investigating reports of serious psychiatric problems, including suicidal behavior, sharp shifts in mood, and vivid nighttime episodes that some patients call "Chantix dreams," associated with use of the product. A new warning came from a report by the Institute for Safe Medication Practices, based on an analysis of "adverse events" reported to the Food & Drug Administration.

In a separate, but related development, Consumers Union reiterated the call for a three-year moratorium on advertising for newly approved drugs, following the release of ISMP's study on the safety of Chantix. The ISMP report can be found at www.ismp.org/docs/vareniclineStudy.asp.

"In light of these preliminary findings, we urge the FDA to undertake a full review of the risks posed by Chantix," aid Steven Findlay, a healthcare analyst at Consumers Union. "While that is underway, the FDA should ask Pfizer to immediately halt all advertising and promotion of Chantix to both doctors and consumers. Meanwhile, in response to the FAA's announcement, GlaxoSmithKline Consumer Healthcare announced that it is offering free nicotine replacement therapy in the form of nicotine lozenges to all licensed pilots now through June 30.

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