FDA Warns of Symptomatic Bradycardia (slowing heart rate) While Taking Combination of Hepatitis C Drugs

The FDA released a new warning that symptomatic bradycardia (serious slowing of the heart rate) can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. Information about symptomatic bradycardia is being added to the Harvoni and Sovaldi drug labels. Health care professionals should refrain from prescribing this combination of drugs, but patients should speak to their health care professionals before stopping their medications.

Hepatitis C, is a viral infection that can last a lifetime. It can cause serious liver problems, including cirrhosis or liver cancer. Harvoni and Sovaldi, used to treat chronic hepatitis C, prevent the virus from multiplying within the body.

The post-marketing adverse event reports included the death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker to regulate their heart rhythms. Other patients recovered after discontinuing one of the above mentioned drugs.

Although health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral drug with amiodarone, in cases where alternative treatments are unavailable, the FDA recommends heart monitoring in an inpatient hospital setting for the first 48 hours, with subsequent monitoring in a doctor's office or self-monitoring of the heart rate every day through at least the first 2 weeks of treatment.

Patients using Harvoni or Sovaldi combined with an amiodarone based drug should seek medical attention right away if they experience signs or symptoms of symptomatic bradycardia such as:

  • Near-fainting or fainting
  • Dizziness or light-headedness
  • Malaise
  • Weakness
  • Excessive tiredness
  • Shortness of breath
  • Chest pains
  • Confusion or memory problems

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report