FAA bans anti-smoking drug Chantix for pilots, air controllers
The action comes after a medical safety group's report warns of side effects such as loss of consciousness and seizures.
washington -- The Federal Aviation Administration today banned pilots and air traffic controllers from using a popular new anti-smoking drug after a medical safety group warned that the medication had apparently contributed to auto accidents and other mishaps that posed risks to both users and others.
The drug, called Chantix, had been hailed as an innovative treatment to help smokers quit. But a report from a medical safety group -- also issued today --linked the medication to a variety of unusual and serious side effects, including loss of consciousness and seizures, and prompted the FAA to act, said spokesman Les Dorr.
The agency had approved the drug last summer, before drug safety regulators began investigating reports of serious psychiatric problems, including suicidal behavior, sharp shifts in mood and vivid nighttime episodes some patients call "Chantix dreams."
The warning was contained in a report by the Institute for Safe Medication Practices based on an analysis of "adverse events" reports submitted to the Food and Drug Administration.
"We have immediate safety concerns about the use of [Chantix] among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury," the study said.
It remained unclear whether other federal safety agencies would follow the FAA's example.
The study also cited a range of other serious reported side-effects, including vision problems, heart rhythm disturbances, seizures and skin reactions. The nonprofit group that conducted the study advises hospitals and doctors on the prevention of medication errors, and is based near Philadelphia.
"These data provide a strong signal that the risks of [Chantix] treatment have been underestimated, and show that a wide spectrum of serious injuries are being reported in large numbers," the report said.
Prescription drugs are usually tested on a few thousand people before approval, but serious problems many not emerge until many more patients have used the medication for a sustained period.
Responding to the study, FDA spokeswoman Susan Cruzan said: "We agree that these findings are a signal that requires further investigation and confirmation, and the FDA has been conducting a review of the adverse events associated with Chantix."
