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FDA updates safety review on CV concerns with Chantix
Results of a large meta-analysis of clinical trials on the smoking cessation drug varenicline demonstrate a higher occurrence of major adverse CV events in patients using the drug as compared with placebo. These events were uncommon in both the varenicline and placebo groups, and the increased risk was not statistically significant, which means it is uncertain whether the excess risk for CV events with varenicline was due to the drug or chance, according to a FDA drug safety communication issued today.
The safety review is an update to a FDA notification of a possible increased risk for CV events with varenicline (Chantix, Pfizer) issued in June 2011. After the initial communication, the FDA required the manufacturer to conduct the meta-analysis to further evaluate the CV safety of the drug. The findings of the meta-analysis are similar to results from the smoking cessation clinical trial of patients with stable CVD that was described in a drug safety communication issued in June 2011, according to the release.
Pfizer has changed the Warnings and Precautions label of the drug to include the updated meta-analysis results.
The FDA has advised health care professionals to weigh the risks and benefits of varenicline.
Varenicline has been proven effective to help patients quit smoking and abstain from smoking for as long as 1 year.