FDA Warns Against Combination of Hepatitis C Treatment and Antiarrhythmic Drug

On March 24, the U.S. Food and Drug Administration (FDA) issued a warning against taking the antiarrhythmic drug amiodarone in combination with hepatitis C drug treatments and another direct acting antiviral. In their announcement, the FDA stated that amiodarone “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” can cause symptomatic bradycardia. The warning will be added to the labels of Harvoni and Sovaldi, and the FDA will continue to investigate the cause of the heart-related events.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, EP Basic Science

Keywords: Amiodarone, Anti-Arrhythmia Agents, Antiviral Agents, Bradycardia, Hepacivirus, Hepatitis C, United States Food and Drug Administration

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