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  • FDA Date: 05/16/2008

    Chantix (varenicline) FDA Drug Safety Communication

    Information for Healthcare Professionals: Varenicline (marketed as Chantix)

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is issuing this Alert to highlight important revisions to the Warnings and Precautions sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms that have occurred in patients taking the drug, including changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. FDA has also approved a revised Medication Guide with this safety information.

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

    View the full FDA Drug Safety Communication on FDA.gov