Chantix Nixed for Pilots; Caution for Truckers, Bus Drivers
Government Officials Eye Safety of Quit-Smoking Drug Chantix
WebMD News Archive
Chantix Decisions continued...
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
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
FDA Weighs In
The FDA approved Chantix 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
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,"
Meanwhile, the FDA asks doctors and patients to report adverse events from
Chantix -- or any other drug -- to the FDA's MedWatch program.