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Thursday, July 02, 2009


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7-2-2009 smoking-cessation drugs varenicline, bupropion

Rockville, MD - The smoking-cessation drugs varenicline (Chantix, Pfizer) and bupropion (Zyban, GlaxoSmithKline) must carry a boxed warning in their labeling that use of the drugs has been associated with serious mental-health events, the US Food and Drug Administration (FDA) has announced. Reported symptoms include changes in behavior, hostility, agitation, depressed mood, suicidality, and attempted suicide.

Similar warnings will be required for bupropion marketed as the antidepressant Wellbutrin and for generic versions of bupropion. They already have black-box warnings for suicidal behavior in treating psychiatric disorders.

If patients report experiencing agitation, depressed mood, or changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior, the FDA recommends that clinicians advise patients to stop taking varenicline or bupropion immediately.

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