June 16, 2011
People taking Chantix should be aware of cardiovascular side effects, including heart attacks, associated with the drug.
After reviewing results of a Chantix clinical trial, U.S. Food and Drug Administration (FDA) has determined the drug may be associated with a small, increased risk of certain cardiovascular side effects in patients who have cardiovascular disease.
Chantix (varenicline) is a prescription medication prescribed for people trying to stop smoking cigarettes.
“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,” the FDA said.
Chantix heart side effects reported included chest pains, nonfatal heart attack, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease.
The Warnings and Precautions section of the drug labeling and the patient Medication Guide will now warn of these heart risks.
- 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.
Healthcare professionals should know:
- 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.
Chantix already carries a warning for risks of suicide.
The FDA will now require the manufacturer of Chantix, Pfizer Inc., to investigate these heart side effects by conducting a large, combined analysis of randomized, placebo-controlled trials.
“As stated by the FDA, patients should contact their healthcare professional if they experience new or worsening symptoms of cardiovascular disease,” manufacturer Pfizer Inc. said in a statement.