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Medication Safety Alerts

Amiodarone and Hepatitis C Treatments FDA Drug Safety Communication

03/24/2015

On March 24, 2015, the United States Food and Drug

Administration (FDA) issued a Drug Safety Communication warning that serious slowing of the heart rate can happen when amiodarone is taken together with either Harvon or with Sovaldi taken in combination with another direct acting antiviral Olysio, for the treatment of hepatitis C infection. Amiodarone is an antiarrhythmic drug and is prescribed to treat an irregular heartbeat.

The FDA has provided the following information:

  • Discuss with your doctor any questions or concerns about your hepatitis C treatment if you are also taking amiodarone. Your doctor will determine the treatment plan that is most appropriate for you.
  • Do not stop taking any of your medicines without first talking to your doctor even if you have signs and symptoms that might suggest symptomatic bradycardia, a slow heart rate.
  • Seek medical attention right away if signs and symptoms of bradycardia are present, such as:
  • Near-fainting or fainting
  • Dizziness or lightheadedness
  • Malaise
  • Weakness
  • Excessive tiredness
  • Shortness of breath
  • Chest pains
  • Confusion or memory problems
  • Other medicines may affect how Harvoni or Sovaldi work. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort (Hypericum perforatum).
  • Read the patient information leaflet you get along with each prescription you receive for hepatitis C drugs and amiodarone as there may be new information.
  • Report any side effects from the combined use of your hepatitis C drugs with amiodarone to the FDA.

CVS/caremark Response: In response to this issue, CVS/caremark is faxing letters to prescribers whose patients are currently using amiodarone together with either Harvoni or with Sovaldi in combination with another direct acting antiviral for the treatment of hepatitis C infection.

For more information about this issue, please call the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888-463-6332) or visit www.fda.gov/Drugs.

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