[03-24-2015] The U.S. Food and Drug Administration (FDA) is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct acting antiviral for the treatment of hepatitis C infection. We are adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. We are recommending that health care professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone.Patients should not stop taking any of their medicines without first talking to their health care professionals.
About Prizm Share
<p>
FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when
antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir
(Harvoni) or Sovaldi in combination with another Direct Acting Antiviral drug
Safety Announcement
[03-24-2015] The U.S. Food and Drug Administration (FDA) is warning that serious slowing of
the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either
the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in
combination with another direct acting antiviral for the treatment of hepatitis C infection. We
are adding information about serious slowing of the heart rate, known as symptomatic
bradycardia, to the Harvoni and Sovaldi labels. We are recommending that health care
professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting
antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone.
Patients should not stop taking any of their medicines without first talking to their health care
professionals.
Harvoni and Sovaldi are used to treat chronic hepatitis C, a viral infection that can last a lifetime
and lead to serious liver problems, including cirrhosis or liver cancer. These drugs reduce the
amount of hepatitis C virus in the body by preventing the virus from multiplying within the
body.
Our review of submitted postmarketing adverse event reports found that patients can develop a
serious and life-threatening symptomatic bradycardia when either Harvoni or Sovaldi combined
with another direct-acting antiviral is taken together with amiodarone. The reports included the
death of one patient due to cardiac arrest and three patients requiring placement of a pacemaker
to regulate their heart rhythms. The other patients recovered after discontinuing either the
hepatitis C drugs or amiodarone, or both (see Data Summary). The cause of these events could
not be de