FDA has safety concern over smoking-cessation drug

NEWS IN BRIEF — Posted Feb. 25, 2008

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The Food and Drug Administration issued a public health advisory about safety concerns associated with Chantix, or varenicline, a prescription medication used to help patients stop smoking.

The advisory warned of behavior changes among those taking the drug that may include agitation, depressed mood, suicidal ideation and actual suicidal behavior.

The warning follows an earlier communication issued last November about the same adverse events.

The FDA has asked that the manufacturer, Pfizer, elevate the prominence of this safety information in the warnings and precautions section of the prescribing information. The FDA is also working with Pfizer to finalize a medication guide for patients.

Chantix was approved in May 2006. The medication acts on sites in the brain affected by nicotine and may help those trying to quit by providing some nicotine effects to ease withdrawal symptoms and block the effects of nicotine from cigarettes if patients resume smoking.

Note: This item originally appeared at

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