FDA requires warnings for use of Sovaldi ( sofosbuvir) or Harvoni (sofosbuvir plus ledipasvir) with amiodarone- Gilead

The FDA has approved changes to the "Warning and Precautions," "Adverse Reactions" and "Drug Interactions" sections of Sovaldi's and Harvoni's labeling to alert prescribers and patients about serious risk of bradycardia when combining the drugs with amiodarone and other DAAs.( direct acting anti virals).The mechanism of the potential interaction between amiodarone and Harvoni, or Sovaldi in combination with another DAA (direct antiviral agent) is unknown.

The FDA said it is recommended that patients who need amiodarone and Sovaldi and amiodarone be monitored in an inpatient setting for the first 48 hours, followed by daily outpatient or self-monitoring of their heart rate for at least the first two weeks of treatment. It said that because amiodarone has a "long half-life," patients who have just gone off of amiodarone ahead of starting Harvoni or Sovaldi along with a DAA should also be monitored.