Alert Is Issued on Smoking Cessation Drug

Article excerpt

The Food and Drug Administration has issued an alert about postmarketing reports of suicidal thoughts, aggressive and erratic behavior, and drowsiness associated with varenicline, the smoking cessation drug marketed as Chantix.

A notice posted in late November on the FDA's MedWatch site advises health care professionals to monitor patients taking varenicline for behavior and mood changes.

The notice also recommends that people who are taking the drug should contact their physicians if they experience mood or behavior changes, and should be cautious when driving or operating machinery, "until they know how quitting smoking with Chantix may affect them."

Varenicline, a nicotine receptor agonist, was approved by the FDA in 2006, and is taken orally.

The notice points out that the review of the drug's safety is ongoing and that the agency is not advising health care providers to stop prescribing the drug.

The FDA is reviewing postmarketing reports of suicidal ideation and occasional suicidal behavior associated with varenicline, recently submitted by the drug's manufacturer, Pfizer Inc. …

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