TIP OF THE WEEK

May 23, 2008

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Trucking Regulators Warn on Use of Chantix

Following the Federal Aviation Administration’s decision to ban use of the anti-smoking drug Chantix by pilots and air controllers on Wednesday, now the Federal Motor Carrier Safety Administration warns against the use of the medication.  The Federal Motor Carrier Safety Administration issued a warning yesterday on the anti-smoking drug Chantix, advising medical examiners "to not qualify anyone currently using this medication for commercial motor vehicle licenses."  The FMCSA oversees the interstate trucking and bus industry.  

The dramatic decisions follow a report by the Institute for Safe Medication Practices, a non-profit watchdog group based in Horsham, Pa., which warns against “use of Chantix among persons operating aircrafts, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury.”

The report linked Chantix to 988 serious events in the last quarter of 2007 alone.

The drug, made by Pfizer, was approved in 2006 for sale in the U.S. and the European Union.  Sales of the drug were $883 million last year and an estimated 6.5 million people have used it worldwide.

Since approval, Chantix has been under fire due to its serious side effects such as depression, suicidal thoughts, aggression, or possible psychosis.  Now, the new report also found the drug responsible for potentially lethal heart rhythm disturbances, heart attack, dizziness, seizures and diabetes in its users.  Of special concern for those operating airplanes and trucks, there were 173 serious injuries, some resulting from traffic accidents where drivers were dizzy, mentally confused or became unconscious.

Following the release of the report, Pfizer issued a statement defending the drug saying its label already contains safety warnings about driving or operating machinery.  “There are few things that provide greater health benefits than quitting smoking.  When considering the use of Chantix for their patients, health care providers should discuss the risks of smoking, the health benefits of quitting smoking, and the product’s efficacy and safety profile,” Francisco Gebauer, a Pfizer representative wrote in the statement, the New York Times reported.

Pfizer added new warnings to the drug’s label no further than February this year, when the FDA warned about the risk of mood and behavior changes.  The warning also said Chantix could impair patient’s ability to drive or use heavy equipment.  Pfizer said on Wednesday that the report's findings were not inconsistent with possible side effects already listed on Chantix's label.  That lists most of the events cited in the institute's report as "infrequent" or "rare."  The company also said that the reports aren't unusual, given that roughly 5.5 million Americans have taken Chantix.

The Department of Transportation, which oversees regulations for railroads and the shipping industry, has alerted its agencies about the study, asking the office directors to be aware of the report's warnings and recommendations and is considering issuing additional guidelines because of the new concerns raised by the study. 

The FDA did not announce any new action.

Patients using Chantix were warned to stop taking it and to immediately call their health care providers if they experience agitation, depression, behavior changes or suicidal thoughts.

For more information about Chantix visit the U.S. Food and Drug Administration's web site at:  http://www.fda.gov/  or visit Pfizer's site on Chantix at:  http://www.chantix.com/content/important_info_about_chantix.jsp.

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