FDA approves changes to hep C drug label to include new warnings

FDA has approved changes to the hepatitis C antiviral simeprevir (Olysio, Janssen) label to include new warnings about serious symptomatic bradycardia-slowing of the heart rate-when co-administered with antiarrhythmic drug amiodarone and antiviral sofosbuvir (Sovaldi, Gilead).

Additionally, hepatic decompensation and hepatic failure warnings also have been added to the label when simprevir is combined with amiodarone and sofosbuvir.

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There are post-marketing reports of symptomatic bradycardia and cases requiring pacemaker intervention when amiodarone was given with sofosbuvir. Additionally, there are post-marketing reports of hepatic decompensation and hepatic failure, including fatal cases when simeprevir was given in combination with peginterferon alfa and ribavirin or in combination with sofosbuvir. It is not recommended for patients with moderate or severe hepatic impairment (Child-Pugh Class B or C) to take simeprevir.

“We’re committed to working closely with regulators to ensure that physicians and patients are provided with accurate information about potential risks associated with the use of our products,” according to Lisa Vaga, Janssen spokesperson.

In March, FDA warned that serious slowing of the heart rate can occur when amiodarone is taken together with either the hepatitis C drug ledipasvir/sofosbuvir (Harvoni) or with sofosbuvir taken in combination with another direct-acting antiviral for the treatment of hepatitis C infection. The post-marketing reports included the death of 1 patient due to cardiac arrest and 3 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.

The agency recommended healthcare professionals should not prescribe either Harvoni or Sovaldi combined with another direct acting antiviral, such as the investigational drug daclatasvir or simeprevir, with amiodarone, but stressed that patients should not stop taking any of their medicines without first talking to their healthcare professionals.

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