FAA: Side effects of Pfizer’s Chantix too dangerous for pilots

posted on:
May 22, 2008

Vittorio Hernandez

Washington, D.C. (AHN) – The anti-smoking drug Chantix was removed by the Federal Aviation Administration from the list of medications deemed safe for pilots and air traffic controllers.

The FAA ban followed a public health advisory issued by the U.S. Food and Drug Administration that contained a five-point safety guide on the severe changes in mood and behavior persons taking Chantix may go through.

The FAA said the connection of Chantix to mental confusion and other problems may endanger the lives of air travelers. Chantix is also known by its generic name varenicline.

FAA based its order on a study posted online by the Institute for Safe Medication Practices (ISMP). Among the side effects of Chantix, manufactured by Pfizer, were loss of consciousness, lapses in alertness, nausea and muscle spasms.

Les Dorr, spokesman of the FAA, said the agency would send letters to the Aircraft Owners and Pilots Association to inform them of the new FAA policy.

Since Chantix came on the market in May 2006, more than 5 million people have used the drug to help them stop their smoking habit. Some 3.5 million users were in the U.S.

Curt Furberg, co-author of the ISMP report, said they posted their findings on their website to disseminate the information as early as possible since publishing it in a medical journal may take half a year before it sees print, and more lives could already be placed on stake.

The FDA advisory said Chantix takers may experience changes in mood and behavior, including having vivid, unusual or strange dreams.

Martina Flammer, senior medical director of Pfizer for Chantix, said the findings of the ISMP study were not new. She added that the study did not specify if the Chantix-related problems was caused by the drug, an after effect of nicotine withdrawal or neither. Flammer vowed Pfizer will continue to monitor the medicine for a long period.

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