Weakening FDA’s Authority Over Tobacco Could Impact Use, Advocates Say
Weakening the Food and Drug Administration’s regulatory authority over tobacco could have an adverse impact on tobacco use, according to advocacy groups.
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.