Harvoni ledipasvir regulatory update

FDA issued a drug safety alert warning of symptomatic bradycardia when the antiarrhythmic amiodarone is taken together with HCV drugs Harvoni ledipasvir/sofosbuvir and Sovaldi sofosbuvir from Gilead. The agency also updated the labels of the HCV drugs with the warning and recommended against prescribing either Harvoni or Sovaldi combined with another direct-acting antiviral with amiodarone.

FDA’s review of postmarketing adverse event reports found that patients can develop serious and life-threatening symptomatic bradycardia with the combinations. The reports included 1 death due to cardiac arrest and 3 patients who required placement of a pacemaker to regulate their heart rhythms. When alternative treatment options are unavailable, 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. ...