FDA warns on using amiodarone in patients given Harvoni or Sovaldi in combination with another direct acting antiviral

25 March 2015

The US Food and Drug Administration is warning that 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.

The agency is adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. It is recommending that health care professionals should not prescribe either of Gilead Sciences’ (Nasdaq: GILD) new blockbuster drugs Harvoni or Sovaldi combined with another direct acting antiviral, such as Bristol-Myers Squibb’s (NYSE: BMY) investigational drug daclatasvir or Johnson & Johnson’s (NYSE: JNJ) Olysio (simeprevir), with amiodarone. Patients should not stop taking any of their medicines without first talking to their health care professionals.

Result of post-marketing adverse events reports review

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