Varenicline: FDA finds cardiovascular adverse events, notes label change

June 30, 2011

FDA has issued a warning that smoking-cessation aid varenicline (Chantix, Pfizer) may be associated with a small, increased risk of certain adverse events in patients who have cardiovascular disease.

Smoking-cessation aid varenicline (Chantix, Pfizer) may be associated with a small increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease, FDA warned patients and healthcare professionals in a recent safety announcement. As a result, the agency is notifying the public that safety information regarding varenicline will be added to the Warnings and Precautions section of the label and to the patient Medication Guide.

The safety alert follows FDA’s review of a study involving 700 smokers with cardiovascular disease who were treated with varenicline or placebo. The study was designed to assess the efficacy and safety of varenicline for smoking cessation. Overall, FDA found cardiovascular events to be infrequent; however, certain events, such as 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.

Although varenicline appears effective in helping patients quit smoking, according to the study, FDA recommends that healthcare professionals weigh the known benefits of varenicline against the potential risks of its use in smokers with cardiovascular disease; counsel patients to seek medical attention if they experience new or worsening symptoms of cardiovascular disease while taking the medication; encourage patients to read the Medication Guide they receive along with their prescription; and report any adverse events to the FDA MedWatch program (www.fda.gov/MedWatch/report.htm).