FDA Issues Suicide Warnings on Chantix, Zyban

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.

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FDA Issues Suicide Warnings on Chantix, Zyban

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.

Leave a Reply

Please read our comment policy and guidelines before you submit a comment. Your email address will not be published. Thank you for visiting Join Together.

Required fields are marked *


*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>