FMCSA Warns About Anti-Smoking Drug Chantix

By Eric Miller, Staff Reporter

This story appears in the June 2 print edition of Transport Topics. Click here to subscribe today.

The Federal Motor Carrier Safety Administration has issued an advisory warning that the popular prescription smoking-cessation drug Chantix may adversely affect commercial drivers’ ability to operate their vehicles safely.

“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 driver’s ability to safely operate a commercial motor vehicle,” FMCSA said in a May 23 statement.

FMCSA said its rules defer to physicians and health-care professionals to determine drivers’ medical fitness for duty.

However, the agency cautioned that it issued the advisory because the drug has “actual and potential side effects that could impact safe driving.”

Neither FMCSA nor Pfizer Inc., the manufacturer of Chantix, commented beyond their written statements.

Dave Osiecki, vice president of safety, security and operations for American Trucking Associations, called the FMCSA advisory “not unprecedented but fairly unusual.”

“FMCSA rarely takes a definitive action where they put out advisories that are fairly definitive in terms of guidance to the medical examiners,” Osiecki said. “It’s a gray area and an area they leave up to the medical examiners.”

Osiecki said the advisory would be helpful to carriers because they can relay it to their in-house or contracted medical personnel and drivers.

Concerns about Chantix, the product name for the drug varenicline, first became public earlier this year when a Food and Drug Administration bulletin requested it carry a warning on its label because the drug reportedly was causing severe changes in mood and behavior.

In a subsequent advisory on May 16, FDA said after a review of the data, it had become increasingly convinced the drug had serious side effects.

Besides mood and behavioral changes, FDA said Chantix may cause worsening of a current psychiatric illness, even if a patient’s illness is currently under control, and may cause an old psychiatric illness to reoccur.

Other symptoms associated with the drug may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide, FDA said.

“While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert patients that they are possible,” the FDA bulletin said.

As a result, the Federal Aviation Administration on May 23 issued a ban on use of the drug by air controllers and pilots.

That prohibition followed a study of the drug by the medical drug-safety nonprofit group, the Institute for Safe Medication Practices, Huntingdon Valley, Pa.

“We have immediate safety concerns about the use of varenicline among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury,” the study concluded.

The study said that from May 2006 through December 2007, the FDA had received 227 domestic reports of suicidal acts, thoughts or behaviors, 397 cases of possible psychosis and 525 reports of hostility or aggression. These totals included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination. The categories were not mutually exclusive.

Chantix, which first hit the market in 2006, has been a best-seller for Pfizer. In 2007, Chantix revenues were $883 million, compared with $101 million in 2006, the company said in its financial statements.

Sales of the drug during the first three months of 2008 totaled $277 million, up 71% compared with the first quarter of 2007.

The drug acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking, FDA said.

The company has said in written documents that in controlled clinical trials of more than 5,000 patients treated with Chantix, changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior occurred at a rate comparable to placebo-treated patients.