FDA MedWatch - Chantix (varenicline): Label Change

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - Chantix (varenicline): Label Change

Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events

[UPDATED 07/22/2011] FDA has approved an updated drug label for 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.

Read the UPDATED MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259469.htm

 

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