Chantix and cardiovascular events

The FDA has issued an alert regarding varenicline (Chantix) regarding a small increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. The warning regarding the smoking cessation drug was the result of review of a randomized, double-blind, placebo-controlled trial of 700 smokers with cardiovascular disease who were treated with varenicline or placebo. The overall rate of adverse effects was low but cardiovascular events, including heart attack, were reported more frequently in the treatment group. The warning will result in a change in labeling for the drug and the FDA is also requiring Pfizer, the drug manufacturer, to conduct an analysis of other trials to further assess the risk. Varenicline already carries a box warning regarding neuropsychiatric symptoms including suicidality.