The FDA is notifying the public that the smoking cessation drug varenicline (Chantix, Pfizer) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
This safety information will be added to the Warnings and Precautions section of the varenicline physician labeling. The patient Medication Guide also will be revised, according to the agency, to inform patients about this possible risk.
The FDA reportedly reviewed a randomized clinical trial of 700 smokers with cardiovascular disease who were treated with varenicline or placebo. In this trial, varenicline was effective in helping patients quit smoking and remain abstinent from smoking for as long as one year. Cardiovascular adverse events were infrequent overall, however, certain events, including heart attack, were reported more frequently in patients treated with varenicline than in patients treated with placebo.