FAA Bans Pilot Use of Pfizer's Chantix

Pfizer (PFE - Cramer's Take - Stockpickr) Thursday will face its first regular trading session and likely a lot of criticism following a report that points to an eyebrow-raising volume of disturbing side effects related to smoking-cessation drug Chantix.

A report by the Institute for Safe Medication Practices (ISMP) says that the non-profit group launched an investigation because in the fourth quarter of 2007 there were 988 serious injuries associated with the drug that were reported to the Food and Drug Administration -- trumping any other marketed drug in that period.

The findings in the analysis -- which the organization said were immediately passed to the FDA -- prompted the Federal Aviation Administration to ban use of the drug by pilots and air traffic controllers.

"Varenicline is suspected in various adverse drug event reports of causing a wide spectrum of injuries, including serious accidents and falls, potentially lethal cardiac rhythm disturbances, severe skin reactions, acute myocardial infarction, seizures, diabetes, psychosis, aggression and suicide," according to the ISMP report.

Pfizer has issued a statement standing behind the integrity of the current safety label for the drug, which was approved in May 2006, but this isn't the first time the drug's risky side effects have come into question.

The FDA said in November that it was reviewing cases of erratic behavior and suicidal thoughts in patients taking the drug. The agency said at that time that it was also evaluating reports of drowsiness that affected patients' ability to drive or operate machinery while taking Chantix.