The Baltimore Sun reported last week that the FAA has banned pilots and air traffic controllers from using the quit-smoking drug Chantix following a study that found it had apparently contributed to auto accidents and other mishaps that posed risks to both users and others.
Chantix began as a success story, billed as a relatively risk free drug that helps you quit smoking in a far more civilized way than just quitting cold turkey. The “easier to quit smoking” part of the hype was as advertised: 44% of people taking Chantix were able to quit smoking in comparison to 17.7% percent of those taking placebos. Chantix is believed to block nicotine from stimulating the certain brain receptors, so nicotine would not give users the dopamine boost they receive when they smoke. Chantix also stimulates the release of low but consistent levels of dopamine to help decrease nicotine urge.
Correctly expecting the drug would be a real money maker ($883 million in 2007 alone), Pfizer had requested and received an accelerated review by the FDA and Chantix was approved in May of 2006. But it takes a while to see if serious side effect will emerge. Pfizer knows this as well as anyone from its experiences with Zoloft, a drug that was on the market for many years before reports of suicidal behavior (and lawyers filing lawsuits) forced Pfizer to put a warning on the drug.
Why doesn’t Pfizer just play it safe and put a suicide warning on the drug? As a lawyer who spent a number of years representing pharmaceutical companies, I certainly have a theory: warnings on the product label would have discouraged general practitioners from prescribing Chantix, which would have hurts sales. But in hindsight, not including a warning is going to cost Pfizer more in defending lawsuits and settling Chantix cases.