The FDA cautions that varenicline may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease.
By Kate H. Gamble, Senior Editor
The FDA announced on June 15 that the smoking cessation aid Chantix (varenicline) 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 Chantix physician labeling. In addition, the patient Medication Guide will also be revised to inform patients about the possible risk.
FDA reviewed a randomized clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo. In the trial, Chantix was shown to be effective in helping patients quit smoking and remain abstinent from smoking for as long as a year. However, although cardiovascular adverse events were infrequent overall, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo.
Healthcare professionals should be aware that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population, according to the FDA. The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease.
FDA is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a meta-analysis of randomized, placebo-controlled trials.
Additional Information for Healthcare Professionals
Additional Information for Patients
For more information about the clinical trial, click here.