NGC Update Service: October 10, 2016 | U.S. Food and Drug Administration (FDA) Advisories

Safety Alerts for Human Medical Products > Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating

U.S. Food and Drug Administration (FDA) Advisories

October 4, 2016: Direct-Acting Antivirals for Hepatitis C: The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks.

NGC Update Service: October 10, 2016