Medical certification of truckers using Chantix not likely

| Wednesday, August 27, 2008

Truckers taking Chantix to help them quit smoking won’t be sailing through the medical certification process.

Growing concern on the part of the Food and Drug Administration prompted the Federal Motor Carrier Safety Administration to caution physicians against certifying the medical fitness of any trucker taking the prescription medication.

“FMCSA’s rules defer to the physicians and health care professionals to determine driver medical fitness for duty, which includes when a medication has actual and potential side effects that could impact safe driving,” John Hill, FMCSA administrator, said in a written statement.

“While we do not name any medications, such as Chantix, in FMCSA regulations, it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the drive’s ability to safely operate a commercial motor vehicle.”

The FDA issued a public health advisory early this year on varenicline, the scientific name of the drug commercially sold as Chantix.

“Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide,” the FDA reported in the advisory.

“While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others symptoms developed following withdrawal of Chantix therapy.”

According to the Institute for Safe Medication Practices, in the fourth quarter of 2007 varenicline accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug. By comparison, the FDA received a median average of five reports of serious injury for 769 different drugs in the fourth quarter.

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