FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban

FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban
Wed, 01 Jul 2009 11:17:00 -0500

The U.S. Food and Drug Administration today announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (buproprion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

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