FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

FDA Warns of Hepatitis B Reactivation Risk in Patients Treated for Hepatitis C

Oct. 11, 2016

The FDA issued a warning about the risk of hepatitis B virus (HBV) becoming active again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for the hepatitis C virus.

A boxed warning on the HBV reactivation risk must be added to the drug labels of these DAAs.

The FDA identified 24 cases of HBV reinfection in patients treated with DAAs from Nov. 22, 2013, to July 18, 2016.

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