Chantix Nixed for Pilots; Caution for Truckers, Bus Drivers
Government Officials Eye Safety of Quit-Smoking Drug Chantix
Chantix Decisions continued...
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.