U.S. Trucking Industry Issues Chantix Warning
Friday, May 23, 2008
On May 22, 2008, the Federal Motor Carrier Safety Administration issued a warning 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. Chantix, manufactured by Pfizer, Inc., was attacked in a study by a non-profit group on May 21, 2008 for possible links to seizures, dizziness, heart irregularity, diabetes and more than 100 accidents.
The Department of Transportation alerted its agencies about the study, asking the office directors be aware of the report's warnings and recommendations.
The Federal Aviation Administration banned the drug for pilots and air traffic controllers on May 21, 2008, hours after seeing the study, which reported that Chantix was linked to 988 serious events in the last quarter of 2007 alone.
The FDA did not announce any new action. Its spokeswoman said that the FDA was concentrating on potential links between Chantix and neuropsychiatric side effects. The FDA and Pfizer updated warnings on Chantix's label this year to include depression and suicidal thinking.
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."
The Chantix study was conducted by The Institute for Safe Medication Practices, a non-profit watchdog group based in Horsham, Pa.
Pfizer said on May 21, 2008 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.
Posted in Dangerous Drugs • Chantix