The FDA has notified the public that the smoking cessation aid Chantix (varenicline; Pfizer) may be associated with a small, increased risk of certain cardiovascular events in patients with cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix product labeling.
The FDA reviewed a randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of Chantix for smoking cessation in 700 patients 35–75 years old with stable, documented cardiovascular disease (other than, or in addition to, hypertension) that had been diagnosed at least two months prior to the screening visit. In this trial, Chantix 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 were reported more frequently in patients treated with Chantix than in patients treated with placebo and included 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
Patients should contact their healthcare provider if they experience new or worsening symptoms of cardiovascular disease while taking Chantix.
For more information visit www.fda.gov/Drugs/DrugSafety/ucm259161.htm.