Warning about varenicline in patients with CVD

A warning will be added to smoking cessation aid varenicline (Chantix) to indicate that the drug may be associated with a small increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease, the FDA announced last week.

The warning is based on FDA review of a placebo-controlled trial of varenicline in 700 smokers with cardiovascular disease. Quit rates were higher in patients taking the active drug but certain cardiovascular events, including angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease, were reported more frequently in patients treated with varenicline. However, the study was not designed to have statistical power to detect differences between the arms on the safety endpoints, according to an FDA press release.

The FDA recommends that clinicians weigh the known benefits of the drug against potential risks when deciding whether to use it in smokers with cardiovascular disease, given that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. Patients should be counseled to seek medical attention if they experience new or worsening symptoms of cardiovascular disease while taking the drug.