According to an article published by Bloomberg news service, a recent review of voluntary adverse event reports associated with Pfizer’s stop-smoking drug Chantix reveals more than 3,000 reports of serious side effects in the U.S. alone. Among problems cited by the nonprofit Institute for Safe Medication Practices, which conducted the study, are suicide, heart trouble and aggression.
As a result of its study, the ISMP is recommending the FDA strengthen warnings on the drug, which has been prescribed to more than 3 million people since it was approved in May 2006. Also as a result of the report, the Federal Aviation Administration banned use of Chantix by pilots and air traffic controllers.
The Bloomberg story cites FDA spokesperson Susan Cruzan as saying the ISMP study will prompt the FDA to conduct immediate further research to confirm numbers. Because the FDA’s adverse event reporting system is voluntary, she is cited as saying, there are no controls in place to determine if the reported side effects are the result of Chantix use, or if they are coming from another drug that reporters may be using.