The FDA is informing the public about the results of a meta-analysis that compared patients who received Chantix (varenicline; Pfizer) to patients who received placebo. Study results showed that a higher occurrence of major adverse cardiovascular events (combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke) was observed in patients using Chantix vs. placebo. The increased risk was found to not be statistically significant.
The FDA first alerted the public about a possible increased risk of cardiovascular events with Chantix in June 2011. The meta-analysis findings are similar to those in the smoking cessation clinical trial of patients with stable cardiovascular disease from June 2011. The Warnings and Precautions section of the Chantix prescribing information has been updated to include the results of the meta-analysis.
Chantix is a smoking cessation aid that works by blocking the effects of nicotine (from smoking) on the brain.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331626.htm.