Twitchy pilots, drowsy truckers, and crazed musicians — all trying to kick the habit

by Anne Law, May 28th, 2008, 7:00 am

Last week the Federal Aviation Administration (FAA) and the Federal Motor Carrier Safety Administration (FMCSA) decided that pilots, air traffic controllers, and truck drivers shouldn’t be allowed to work while taking smoking cessation drug Chantix due to a recent report that linked the drug to an increase in accidents (such as falls and traffic incidents) and a wide variety of maladies including dizziness, confusion, muscle spasms, diabetes, and heart problems.

The news comes as an added blow to Pfizer, which is counting on new drug releases like Chantix to save its bottom line in future years. The drug already carries warnings for several side effects, and sales have been negatively affected by publicity surrounding the drug’s psychiatric risks, especially after a much-publicized musician’s death and other reports of bizarre behavior that have been connected to Chantix.

The recent study, released by the Institute for Safe Medication Practices, is based on FDA adverse events reports and has prompted calls for increased (black box) warnings for the medication. Pfizer argues that the nearly 1,000 events reported during the fourth quarter of 2007 (out of some 5.5 million total prescriptions written) outlined in the study are still “infrequent” as the existing label implies.

This number ratio is higher, however, than all of the other drugs examined by the institute for that period, and most that come close already have black box warnings. The FDA is looking into Chantix’ psychiatric side-effects, as well as reports of drowsiness, but says that it likely won’t have the manpower to put behind an additional investigation.

Despite the FDA’s sluggishness, it seems inevitable that the agency will soon add black box warnings for many of the Chantix symptoms outlined in the study, as the drug is increasingly in the public spotlight. While this drug has reportedly helped millions drop a potentially life-threatening habit, the question remains whether the benefits outweigh the possibility of equally lethal side-effects. Certainly, actions taken by the FAA and FMCSA to ban the drug are understandable and will likely prompt scrutiny of the drug by other employers and patients.

Pfizer, on the other hand, has no plans to stop promoting the drug, which works to block the effects of nicotine on the brain, and is launching the drug in additional markets.