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
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,
"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.