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Chantix Too Dangerous for Truckers and Bus Drivers, Federal Agency Says

May 28, 2008 | Parker Waichman LLP A federal agency has said truckers and bus drivers should steer clear of the smoking cessation drug Chantix.  The move comes after a recent study indicated that Chantix put users at a higher risk for traffic accidents.  It is just the latest problem linked to the Pfizer drug, which has also been linked to psychological side effects, including suicidal thoughts and behavior.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.  

But last week, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA.  The report specifically cited  224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes.  There were also reports of a dozen traffic accidents linked to Chantix.  The Institute’s report has already gotten the attention of the Federal Aviation Administration, which has banned its use by pilots and air traffic controllers.

Now, the Federal Motor Carrier Safety Administration (FMCSA), a division of the Department of Transportation, is warning bus and truck drivers to stay off Chantix.  In a statement, the FDCSA told CBS 11 in Texas 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."

Since its approval, Chantix has been the subject of a number of safety concerns.  Chief among them is its apparent link to suicidal thoughts and behavior.  Last year, in a Nov. 20 Early Communication, the FDA said that a preliminary assessment of Chantix suicide reports revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.  In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.

None of this is good news for Pfizer.  Chantix was Pfizer’s most promising drug, with some analysts estimating its sales could reach $2.28 billion by 2012.  But Chantix’s problems could soon have many rethinking those forecasts.  Some analysts have already said forecasts for Chantix sales could be downgraded by as much as 30 percent.

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