SILVER SPRING, MD — The US Food and Drug Administration (FDA) has approved a label change for the hepatitis C (HCV) antiviral simeprevir (Olysio, Janssen Therapeutics) to warn prescribers and patients of an increased risk of serious symptomatic bradycardia when the drug is combined with amiodarone and the antiviral sofosbuvir (Sovaldi, Gilead Sciences).

The label change also warns of an increased risk of liver decompensation and liver failure when simeprevir is used with amiodarone and sofosbuvir.

In March, the FDA updated labeling information for sofosbuvir and the HCV antiviral combination of ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) to reflect an increased risk of cardiac eventsafter the manufacturer reported nine cases of treatment-related adverse events, including bradycardia, pacemaker intervention, and even death, in patients taking amiodarone and other antiviral agents, including simeprevir.

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