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FDA Warns of Fatal Heart Reaction With Sovaldi and Harvoni

The Food and Drug Administration (FDA) is warning that fatal heart arrhythmias can occur when Sovaldi and Harvoni are used in combination with an antiarrhythmic medication.

About Sovaldi and Harvoni

Gilead Sciences makes both Sovaldi and Harvoni, which are used to treat hepatitis C. The antiarrhythmic drug is amiodarone and is indicated for treating ventricular fibrillation and hemodynamically unstable ventricular tachycardia.

Harvoni is a combination of ledipasvir and sofosbuvir and is indicated for the treatment of group 1 hepatitis C. Sovaldi, active ingredient sofosbuvir, is intended to be used in combination with another antiviral agent for the treatment of group 1 hepatitis C.

Bloomberg reports that both hepatitis C drugs were approved within the last two years and that the cost of treatment for each is over $1000 per day.

FDA Reports 1 Person Has Died and 3 Needed Pacemakers

The FDA is warning that when Harvoni and Sovaldi are taken in combination with amiodarone a potentially fatal slowing of heart rate, called symptomatic bradycardia, can occur, according to PharmaNewsToday.

The Wall Street Journal is reporting that the FDA has received a report of one person dying of cardiac arrest following administration of the hepatitis C drug along with amiodarone. The combination of Solvadi or Harvoni with amiodarone has also lead to several people requiring implantation of a pacemaker to treat the slower heart rate, according to Medline Plus.

Medscape reports that the FDA labels for Sovaldi and Harvoni will be changed to include warnings for symptomatic bradycardia when the drugs are administered with amiodarone.

It Is Recommended to Not Use Sovaldi and Harvoni with Amiodarone

The American Pharmacists Association reports the FDA is recommending that Harvoni or Sovaldi not be prescribed in combination with amiodarone. Most of the adverse events occurred within 24 hours of starting the hepatitis C treatment and that all the reported reactions occurred within 2 weeks, according to Forbes.

FiercePharma is reporting that Gilead is recommending that if the drugs have to be used in combination, then the person should be monitored for the first 48 hours in the hospital and should have a daily outpatient/self monitoring program for at least the first two weeks.

The Mayo Clinic reports that bradycardia is a heart rate lower than 60 beats per minute and can have the following symptoms:

  • Fainting
  • Near fainting
  • Weakness
  • Dizziness
  • Lightheadedness
  • Fatigue
  • Shortness of breath
  • Confusion and/or memory problems
  • Chest pain

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