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FDA Drug Safety Podcast for Healthcare Professionals: Chantix (varenicline) may increase the risk of certain cardiovascular adverse events in patients with cardiovascular disease

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. On June 16, 2011, the Food and Drug Administration issued a Drug Safety Communication notifying 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 physician labeling. The patient Medication Guide will also be revised to inform patients about this possible risk.

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 one 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.

FDA is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a large, meta-analysis of randomized, placebo-controlled trials. FDA will update the public when additional information is available.

At this time, FDA recommends that Healthcare Professionals:

  1. Know that smoking is an independent and major risk factor for cardiovascular disease, and Chantix is effective in helping patients quit smoking.
  2. 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.
  3. Weigh the known benefits of Chantix against the potential risks of its use in smokers with cardiovascular disease.
  4. Counsel patients to seek medical attention if they experience new or worsening symptoms of cardiovascular disease while taking Chantix.
  5. Encourage patients to read the Medication Guide they receive along with their Chantix prescription.
  6. Report adverse events involving Chantix to the FDA MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Please read the Drug Safety Communication for the complete data summary and background information detailing this communication. A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.


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