Back to RecallTracker
Health Canada Health products

Amiodarone - Slow Heart Rate in Patients Taking Amiodarone Together with Harvoni or Sovaldi and a Direct Acting Antiviral

Issued April 2, 2015
Issue
Gilead Sciences Canada, in consultation with Health Canada, would like to inform healthcare professionals, caregivers and patients of important safety information related to the development of serious symptomatic bradycardia (slow heart rate) in patients who are treated with amiodarone concomitantly with a) Harvoni™ or b) Sovaldi ® in combination with another Direct Acting Antiviral (DAA). DAA are drugs that directly target specific steps or encoded proteins vital to the replication of the virus within the Hepatitis C Virus (HCV) life cycle. Nine cases of symptomatic bradycardia have been reported during postmarketing use in patients receiving amiodarone with either Harvoni™, or Sovaldi ® in combination with another DAA.
Hazard description
Product safety