ISMP's Research Prompts FAA To Ban Anti-Smoking Drug Chantix

The world’s leading pharmaceutical company, Pfizer Inc.’s smoking-cessation drug Chantix induces many serious side effects, including suicides, heart trouble and aggression, a study by a health watchdog group unveiled on Wednesday.

Responding quickly to the research, U.S. aviation regulators on Wednesday, prohibited use of the drug by private and commercial pilots, citing potential side effects that could pose a threat to the safe operation of aircraft.

The Federal Aviation Administration said it would no longer permit pilots or air traffic controllers to use the stop-smoking pill Chantix. "It's prudent to deem the drug no longer acceptable for use," said FAA spokesman Les Dorr.

The Food and Drug Administration issued a warning in February, saying Chantix may induce many behavioral changes in a person. The most common of these side effects are suicidal thoughts, aggressive and violent behavior, vivid nightmares and erratic mood swings, the agency said at the time.

The U.S. health agency issued the warning after analyzing the cases of depression, suicidal thoughts and other unusual behavior in patients using the drug. They found the stronger evidence of an association between erratic behavior and serious mood symptoms and Chantix.

FDA has received 491 reports of suicidal behavior associated with Chantix, Dr. Celia Winchell, a team leader in the FDA's Division of Anesthesia, Analgesia and Rheumatology Products, said at the time. Of the total reported cases, 420 are from the United States and of the total 39 completed suicide cases, 34 are alone in the United States, he added.

After analyzing the side effects reported to the FDA, the ISMP stated in its report that health regulators should tighten warnings on the Chantix pill that generated well over $883 million in sales last year.

"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," said the nonprofit group in the study.

According to an FAA spokeswoman, Laura Brown, the agency had approved the use of Chantix for airline pilots and flight controllers last year, but, after the new research, it now considers the drug no longer safe. She said the agency has identified 150 pilots and 30 air traffic controllers that have taken or may currently be taking Chantix. The pilots and air traffic controllers known to be using it are notified by the agency by letter, urging them to stop taking the drug immediately and to not work for 72 hours after ceasing the medication.

Chantix is a nicotine-free, oral tablet which is to be taken twice a day for 12 weeks to help adults quit smoking. This works by cutting the pleasure of smoking and reducing withdrawal symptoms by the help of an active ingredient Varenicline.

Chantix was approved in May 2006 and has since been prescribed more than 4.0 million times in the U.S. alone. The drug has been a success story for Pfizer having generated sales of $280 million in the fourth quarter of 2007 compared to older drugs which face stiff competition from cheaper generics. Last year, an estimated 6.5 million people have used the drug.