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

FROM THE WEBMD ARCHIVES

Chantix, a quit-smoking drug, is being banned for pilots and controllers of air traffic. Chantix may also be cause for medical examiners not to allow interstate truckers or bus drivers to drive.

According to Les Dorr, spokesperson for the Federal Aviation Administration (FAA), Chantix is no longer allowed for pilots or controllers to use. The Federal Motor Carrier Safety Administration, the U.S. Department of Transportation branch that regulates trucking and busing, has informed medical advisors that Chantix could cause interstate bus or truck driver’s medical ineligibility for duty.

Since late last year, the FDA has been reviewing Chantix users’ reports of adverse events.

Janet Woodcock MD, director at the FDA’s Center for Drug Evaluation and Research tells WebMD that “In November we had put on [Chantix] the label a precaution about using heavy machinery.”

Woodcock says that not every drug is right for everyone. Woodcock says that sedation and other risks might be an additional risk for someone who is in a specialized job. If they are required to use a drug, such as a tranquilizer, they should either halt their occupation or avoid flying while on the drug.

Are you a pilot, trucker or bus driver? You should be aware of any drug labels if you are a driver. Woodcock says that many, many medications could impair your driving abilities. “Patients should be careful when taking medication with these precautions,” Woodcock says.

Chantix is manufactured by Pfizer, a drug company. A spokesperson from Pfizer was not available at the time of publication.

Pfizer added a link to “new safety information” to Chantix’s May 2008 website. It includes information about mood changes, suicidal thoughts and behaviors, as well as cautions about heavy machinery or driving. This information is already on Chantix labels.

Chantix Decisions

According to Dorr, Chantix was approved by the FAA for pilots and air traffic controllers in July 2007.

Dorr tells WebMD that this was before reports of possible psychological symptoms started to come in to the FDA in November.

Dorr reports that the FAA received information from the Institute for Safe Medication Practices earlier in the week about a new ISMP listing of Chantix users who have reported problems.

The FDA received reports of problems such as seizures, vision problems, accidents and heart rhythm problems. However, Chantix was not found to be the cause. According to Dorr, the FAA banned Chantix from pilots and air traffic controllers on the basis of that study.

According to Dorr, the FAA has information on about 150 pilots and 30 controllers who have used Chantix in the past. Dorr also notes that the FAA advised pilots and controllers to stop using Chantix and wait 72 hours before flying again.

Is this a permanent decision? Dorr says, “It’s difficult to say.” “We are always open to new data. To make it acceptable again, we would need to have really good data to prove the opposite. This is unlikely to happen.

Chantix has not been banned by the FMCSA for bus and truck drivers. The FMCSA stated in a statement sent to WebMD that it leaves the decision of medical professionals and doctors to determine whether drivers are fit for duty. This includes the potential impact of medication use.

FMCSA regulations don’t single out medications. FMCSA says that Chantix may cause adverse effects on a driver’s ability and safety to operate a commercial motor vehicle.

FDA weighs in

Chantix was approved by the FDA in May 2006.

The FDA announced in November 2007 that it was looking into reports of people taking Chantix exhibiting suicidal thoughts, aggressive or erratic behavior, and drowsiness. The FDA advised patients at the time to be cautious when operating machinery or driving until they understood how Chantix might affect them. It was also stated that the FDA didn’t know if Chantix could be responsible.

FDA officials reported that they had received close to 500 reports of suicide attempts and suicidal thoughts from Chantix users. These reports do not prove that Chantix is to blame for suicidal thoughts, behaviors or suicides. People taking Chantix were warned by the FDA that they may have difficulty driving heavy machinery or operating it.

The ISMP’s latest study has not been published in any peer-reviewed journal.

Renee Brehio is the ISMP public relations manager. She tells WebMD that she chose to publish it in her newsletter and make it available online, because it can take so much time to get into a peer reviewed publication. “ISMP felt strongly that this was an important enough safety issue that it didn’t make sense for there to be a delay between publishing the findings and publication.

Woodcock notes that the ISMP report does not analyze raw FDA data regarding adverse events reported. These reports have been investigated by the FDA. Woodcock says, “We’ve also been looking at what further studies could possibly be done to assess them.”

The FDA is asking doctors and patients to report any adverse effects from Chantix or any other drug to the FDA’s MedWatch program.

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Updated 01/24/22