More than 1,500 additional cases of liver injury have been discovered that are associated with the newest class of hepatitis C drugs. In October, the FDA first identified 24 cases involving safety issues related to the 9 new antiviral drugs for hepatitis C, including Harvoni (ledipasvir-sofosbuvir), Olysio (simeprevir) and Sovaldi (sofosbuvir). While these drugs appeared to lower the hep C virus to undetectable levels in the majority of patients, some of them experienced reactivation of hepatitis B that had serious health consequences, including liver transplant and death. An investigation by the Institute for Safe Medicine Practices of FDA adverse events data identified 524 reported cases of liver failure associated with the drugs, and another 1,058 reports of liver injury. In a further 761 cases, the adverse event was failure of the antiviral drug against the virus. Posted January 25, 2017. Via ISMP.
Source: Harvoni Archives – MedShadow