Aviation, Trucking Regulators Warned About Dangers of Pfizer Drug

Smoking cessation drug Pfizer comes with more than a few side effects

Pfizer’s new smoking cessation drug, Chantix, has hit a few bumps in the road since it received FDA approval in May 2006. The drug’s sales have been stumbling since this the FDA announced new label warnings were necessary due to increasing evidence that drug triggers changes in behavior and suicidal tendencies in some patients. Now, other potentially dangerous side effects are coming to light, but you wouldn’t know it from their adorable television commercials.

On Wednesday, a study was released by the not-for-profit organization, the Institute on Safe Medication Practices. It blasted the drug for adverse reactions such as “serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, abnormal muscle spasms/movements, visual disturbances, diabetes, sudden losses of consciousness, psychosis, aggression and suicide.” The drug accounted for 988 reports of serious injuries in the 4th quarter of 2007, more than any other drug in that period. In fact, 35 other drugs made up all the remaining 100 reports for the quarter. The Institute recommended that the drug be banned in all settings “where a lapse in alertness or motor control could lead to massive, serious injury.”

Hours after the ISMP’s study was released, the Federal Aviation Administration announced they would ban the drug for all pilots and air traffic controllers. Yesterday, the agency that oversees the trucking and busing industries, the FMCSA, requested that medical examiners “not qualify anyone currently using this medication for commercial motor vehicle licenses.”

The FDA has yet to announce any new action. Agency spokesperson, Susan Cruzan, said they would continue to focus on the drug’s link with neuropsychiatric side effects. “The agency has chosen to focus its current safety reviews on issues relevant to psychiatric adverse events but will continue to review other ADEs [adverse drug events] over time,” she told the press.

On Wednesday, drug-maker, Pfizer, minimized the information released in the ISMP’s report, saying most of the events reported were “infrequent” or “rare.” The company said the serious side effects are already listed on the drug’s warning labels, and over 5.5 million Americans have used the drug. Granted, just because 20 million Americans used Vioxx, didn’t make it safe.
Prescriptions of Chantix were last month by over 23% on last year. And sales estimates on the drug have been cut by more than 20% this year, 42% next year and at least 50% the following year.

To learn more about prescription injuries, click here.