The European Medicines Agency has confirmed a risk of severe bradycardia or heart block when certain hepatitis C medicines are used in patients who are also taking amiodarone.
The warning concerns Harvoni (sofosbuvir with ledipasvir) or a combination of Sovaldi (sofosbuvir), both from USA-based Gilead Sciences (Nasdaq: GILD), and Daklinza (daclatasvir), from Bristol-Myers Squibb (NYSE: BMY).
The EMA recommends that amiodarone should only be used in patients taking these hepatitis C medicines if other antiarrhythmics cannot be given. If concomitant use with amiodarone cannot be avoided, patients should be closely monitored. Because amiodarone persists for a long time in the body, monitoring is also needed if patients start such hepatitis C treatments within a few months of stopping amiodarone.
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