Chantix Nixed for Pilots; Caution for Truckers, Bus Drivers
Government Officials Eye Safety of Quit-Smoking Drug Chantix
By
Miranda Hitti
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.
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.
SOURCES: Les Dorr, spokesperson, Federal Aviation Administration. Statement, Federal Motor Carrier
Safety Administration. Janet Woodcock, MD, director, Center for Drug Evaluation and Research. WebMD Health News: "FDA OKs New Quit-Smoking Drug." WebMD Health News: "Suicidal Thinking Reported With Chantix." WebMD Health News: "Suicide Warning for Antismoking Drug." Chantix.com: Renee Brehio, spokesperson, Institute for Safe Medication Practices.
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