Patients taking the stop-smoking drugs Chantix and Zyban/Wellbutrin should be closely monitored for symptoms of serious mental illness that could lead to the risk of suicide, according to a new directive from the U.S. Food and Drug Administration (FDA).
The New York Times reported July 2 that FDA officials stressed that patients should not be discouraged from taking the drugs. “Stopping smoking is a goal we should all be working towards,” said FDA official Curtis J. Rosebraugh. “We don't want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”
FDA announced plans to add a stronger warning to Chantix packaging, and drug maker Glaxo will add the warnings currently on Wellbutrin to Zyban — both formulations of the drug buproprion.
Sales of smoking-cessation drugs have declined in recent years. Chantix, made by Pfizer, controls about 90 percent of the smoking-cessation drug market, with $846 million in annual sales. Still, the drug has fallen short of sales expectations, in part because of prior safety concerns.