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.
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.
Is that decision permanent? "It's hard to say," says Dorr. "We're always open to new data. ... We would have to have some really good data that showed something to the contrary in order to make it acceptable again, and that's probably not going to happen."
The FMCSA hasn't banned Chantix for truckers or bus drivers. In a statement emailed to WebMD, the FMCSA says it defers to doctors and health care professionals to determine drivers' medical fitness for duty, including the possible impact of medication use.
FMCSA regulations don't single out medications. But the FMCSA states that "it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver's ability to safely operate a commercial motor vehicle."
FDA Weighs In
The FDA approved Chantix in May 2006.
In November 2007, the FDA announced that it was investigating reports of suicidal thinking, aggressive and erratic behavior, and drowsiness in people taking Chantix. At the time, the FDA advised patients to use caution when driving or operating machinery until they knew how Chantix may affect them. The FDA also stressed that it didn't yet know if Chantix was responsible for those problems.
In February 2008, FDA officials noted that they have received nearly 500 reports of suicidal thoughts, behaviors, and completed suicides in people taking Chantix. Those reports don't prove that Chantix was to blame for suicidal thinking, behaviors, or suicides. The FDA warned people taking Chantix that they might have trouble driving or operating heavy machinery.
The ISMP's new study hasn't been published in a peer-reviewed journal.
"We actually chose to go ahead and publish it in our newsletter and offer it online because it can take so long to get into a peer-reviewed publication," Renee Brehio, ISMP public relations manager, tells WebMD. "ISMP really felt strongly that this was a crucial enough safety issue that we didn't want there to be that lag time between the findings and getting it published."
The ISMP report doesn't analyze the FDA's raw data on reported adverse events, notes Woodcock. The FDA has been investigating those reports. "We've also been considering what further studies could be done to evaluate them," says Woodcock.
Meanwhile, the FDA asks doctors and patients to report adverse events from Chantix -- or any other drug -- to the FDA's MedWatch program.