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.
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.
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.
Meanwhile, the FDA asks doctors and patients to report adverse events from Chantix — or any other drug — to the FDA’s MedWatch program.
This is shows how powerfull drug companies like Pfizer continue to turn a profit even at the sacrifice of others. 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.