FDA Drug Safety Communication: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease
The U.S. Food and Drug Administration (FDA) notified the public 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 prescribing labeling. The patient Medication Guide will also be revised to inform patients about this possible risk.
The FDA reviewed a randomized clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo. In this trial, Chantix was effective in helping patients quit smoking and remain abstinent from smoking for as long as 1 year. Cardiovascular adverse events were infrequent overall; however, 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. The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease.
Patients taking Chantix should contact their healthcare professional if they experience new or worsening symptoms of cardiovascular disease.
The FDA is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a large analysis. The FDA will update the public when additional information is available.
Additional Information for Patients
- Smoking is a major risk factor for cardiovascular disease, and Chantix can help you quit smoking.
- If you have cardiovascular disease, taking Chantix may increase your risk of certain cardiovascular adverse events.
- Contact your healthcare professional if you experience new or worsening symptoms of cardiovascular disease while taking Chantix, for example:
- Shortness of breath or trouble breathing
- New or worsening chest pain
- New or worse pain in legs when walking
- Read the Medication Guide you get along with your Chantix prescription. It explains the risks associated with the use of Chantix.
- Talk to your healthcare professional if you have questions or concerns about Chantix.
- Report side effects from the use of Chantix to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.
Additional Information for Healthcare Professionals
- Smoking is an independent and major risk factor for cardiovascular disease, and Chantix is effective in helping patients quit smoking.
- Be aware that a small, increased risk of certain cardiovascular adverse events was reported in a study of patients with cardiovascular disease receiving Chantix. The events 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.
- Weigh the known benefits of Chantix 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 Chantix.
- Encourage patients to read the Medication Guide they receive along with their Chantix prescription.
- Report adverse events involving Chantix to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.
Source: Food and Drug Administration