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Chantix Nixed for Pilots; Caution for Truckers, Bus Drivers

Government Officials Eye Safety of Quit-Smoking Drug Chantix
By
WebMD Health News
Reviewed by Louise Chang, MD

May 23, 2008 -- The quit-smoking drug Chantix is being grounded for pilots and air traffic controllers, and Chantix use may be reason for medical examiners to disqualify interstate truckers and bus drivers.

The Federal Aviation Administration (FAA) ruled on Wednesday that "Chantix was no longer acceptable for use by pilots and controllers," FAA spokesperson Les Dorr tells WebMD. And the Federal Motor Carrier Safety Administration -- the branch of the U.S. Department of Transportation that oversees trucking and busing -- has told medical advisors that Chantix use could put the brakes on an interstate truck or bus driver's medical fitness for duty.

The FDA has been analyzing reported adverse events -- including suicidal thoughts and suicidal behavior -- in Chantix users since late last year.

"In November, we had put on the [Chantix] label a precaution about use when operating heavy machinery," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, tells WebMD. 

"Every drug is not right for every person," says Woodcock. "If they're in a specialized occupation where sedation or other problems might pose an extra risk, then if they need to go on a drug like this, they need to take a brief pause from that occupation or not do it while they're, say, flying an airplane."

Not a pilot, trucker, or bus driver? If you drive at all, you should still take note of drug labels. "Many, many medications can impair your driving ability," says Woodcock. "People should be very careful when they're taking any medication that has these labeled precautions."

A spokesperson for Pfizer, the drug company that makes Chantix, wasn't available for comment in time for publication.

However, Pfizer updated the Chantix web site with a "new safety information" link, dated May 2008, about reported mood changes, suicidal thoughts or behaviors, and cautions about driving or using heavy machinery. That information is already on the Chantix label.

Chantix Decisions

In July 2007, the FAA decided that Chantix was acceptable for use by pilots and air traffic controllers, with some exceptions, according to Dorr.

"That was before the first reports started coming to the FDA in November of potential psychological symptoms," Dorr tells WebMD.

Dorr says that earlier this week, the FAA heard from the nonprofit Institute for Safe Medication Practices (ISMP) about a new ISMP list of reported problems in Chantix users.

That study lists problems -- including accidents, vision problems, heart rhythm problems, and seizures -- reported to the FDA but not proven to be caused by Chantix. The FAA decided to ban Chantix for pilots and air traffic controllers based on that study, says Dorr.

The FAA knows of about 150 pilots and 30 air traffic controllers taking Chantix or have taken the drug in the past, notes Dorr, adding that the FAA told pilots and air traffic controllers to stop taking Chantix and to wait 72 hours before going back to work or flying.

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