EMA confirms heart risk with use of some hepatitis C drugs and amiodarone

The European Medicines Agency on Friday confirmed a risk of severe bradycardia or heart block when Gilead Sciences' Harvoni (sofosbuvir/ledipasvir), or a combination of the company's Sovaldi (sofosbuvir) and Bristol-Myers Squibb's Daklinza (daclatasvir), are used in patients taking the antiarrhythmic amiodarone. The agency recommended that amiodarone should only be used in patients taking the hepatitis C therapies if other antiarrhythmics cannot be given.

Last month, the FDA issued a warning about the potential risk of serious bradycardia after Gilead had notified healthcare workers of nine cases of symptomatic bradycardia, as well as one death, among patients co-administered amiodarone with either Harvoni or Sovaldi.

The EMA stated that a review of severe bradycardia or heart block cases in patients prescribed amiodarone who started treatment with the hepatitis C drugs indicated "there was a likely relationship of these events to the medicines." Specifically, among the eight cases reviewed up to this month, one resulted in fatal cardiac arrest and two required pacemaker intervention, the agency said. Further, the onset of bradycardia in six of the cases occurred within 24 hours of initiating hepatitis C treatment, and within two to 12 days in the other two instances.

The EMA said it is not possible to estimate the incidence of these events as it is unknown how many patients were taking amiodarone concomitantly with the hepatitis C drugs. The possible mechanism is also not currently understood, but the regulator said that investigation of additional cases with Sovaldi and other hepatitis C drugs is ongoing. In the meantime, product information for Harvoni, Sovaldi and Daklinza "will be updated appropriately," the agency said.

For related analysis, see ViewPoints: Analysts downplay the impact of safety signal for Gilead’s HCV drugs.

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