The Federal Motor Carrier Safety Administration today issued a warning advising medical examiners "to not qualify anyone currently using this medication (Chantix) for commercial motor vehicle licenses."
The anti-smoking drug Chantix (varenicline), made by Pfizer Inc., came under fire earlier this year when the U.S. Food and Drug Administration upped an early communication to a warning due to the increased number of adverse side effects being reported. In February the FDA required Pfizer to include a warning about the possible neuropsychiatric symptoms.
The FMCSA based their decision on...
a study released by the non-profit organization Institute for Safe Medication Practices and Wake Forest University earlier this week that warned of possible links to seizures, heart irregularities, diabetes, dizziness and more than 100 accidents.
The FMCSA which oversees the interstate trucking and bus industry joined The Federal Aviation Administration who announced its decision to ban the drug for all pilots and air traffic controllers.
The FDA has chosen not to take any new action regarding Chantix based on the report but stated that it was concentrating on possible links between Chantix and the previously acknowledged neuropsychiatric side effects.
Susan Cruzan of the FDA said, "The agency has chosen to focus its current safety reviews on issues relevant to psychiatric adverse events but will continue to review other ADEs over time."
Pfizer stated that all adverse event reported in the study are "not inconsistent" with possible side effects already listed on the drugs warning label and that the number of reported events are not unusual considering that over 5.5 million Americans have taken the drug in an effort to quit smoking.
[Source: Wall Street Journal]
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