The Federal Aviation Administration on Wednesday removed the smoking cessation drug Chantix from the list of medications considered safe for pilots and air-traffic controllers after a new study linked the medication to mental confusion and other problems that could put passengers at risk.
FAA spokesman Les Dorr said the agency took that step after reviewing the study, which raises concerns about Chantix use by people operating vehicles.
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The study links the drug to loss of consciousness, lapses in alertness, dizziness and muscle spasms. Dorr said the FAA has not heard of crashes linked to Chantix. The FAA will send letters about the change to the Aircraft Owners and Pilots Association, pilots’ unions and people “we know are taking” the drug.
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The study was posted online by the non-profit Institute for Safe Medication Practices. Co-author Curt Furberg, a Wake Forest University medical epidemiologist, said he and his coauthors felt “this was too important” to submit first to a medical journal, which could take six months or more to publish.
Since Chantix’s approval in May 2006, Furberg said, 5 million people have taken the drug worldwide, 3.5 million in the USA.
As new problems have been reported, the drug’s label has been updated several times. In February, the Food and Drug Administration issued an alert about label revisions warning of depressed mood, suicidal thoughts and suicide linked to the drug. On Friday, the FDA approved a new medication guide to be distributed by pharmacists.
“We agree that these findings are a signal that requires further investigation and confirmation,” FDA spokeswoman Susan Cruzan said.
Furberg and his co-authors reviewed hundreds of adverse event reports forwarded to the FDA by Chantix maker Pfizer. In the last quarter of 2007, Chantix accounted for 988 reports of serious injuries, more than any other drug; only 35 drugs accounted for at least 100 reports of serious injury.
“This is not any new data,” said Martina Flammer, Pfizer’s senior medical director for Chantix. It’s not clear whether problems in Chantix users are due to the drug, nicotine withdrawal or neither, Flammer said. As with any drug, she said, Pfizer will continue to monitor and study Chantix for “many, many years.”
Meanwhile, Furberg said, if you’re taking Chantix, “I would say there’s a risk. Talk to your doctor and consider stopping the medication. Taper it …It takes a little while for the body to adjust to not taking the drug.”