Drug Safety and Availability > FDA Drug Safety Communication: Chantix (varenicline) drug label now contains updated efficacy and safety information

The following announcement is related to planned labeling changes that were described in the recent FDA Drug Safety Communication on Chantix (varenicline) on 6/16/2011.

The U.S. Food and Drug Administration (FDA) has approved an updated drug label for the smoking cessation aid Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from giving up smoking—those with cardiovascular disease and those with chronic obstructive pulmonary disease (COPD). The updated label now also includes alternative directions for patients to select a quit smoking date.

* Updated information on the use of Chantix in patients with stable cardiovascular disease
* Information on the use of Chantix in patients with COPD
* Alternative directions for patients to select a quit smoking date after they have already started taking Chantix

Information from the three clinical trials reviewed has been added to the Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies, and Patient Counseling Information sections of the Chantix physician label. The patient Medication Guide has also been updated to include information about cardiovascular adverse events and alternative directions to select a quit date.

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