FDA Warns of Heart Attack Risk for Chantix Users

Everyone knows that smoking is bad for you. Among other things, it can contribute to heart disease. And now it turns out that the smoking-cessation drug Chantix may cause problems for consumers who have cardiovascular disease.

The U.S. Food and Drug Administration (FDA) says it has determined that Chantix (varenicline) may be associated with a small, increased risk of heart attacks and other "cardiovascular adverse events" in patients who have cardiovascular disease.

New warnings will be added to the drug's labeling and medication guides.

The FDA said it reviewed a randomized clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo.

The good news is that Chantix was effective in helping patients quit smoking and remain abstinent from smoking for as long as one year.

But while 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.

Benefits vs. risk

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.

Additional information

The FDA offers these tips to 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.