FDA Warns That Hep C Meds Can Reactivate Hep B

Law360, New York (October 4, 2016, 6:55 PM EDT) -- The U.S. Food and Drug Administration on Tuesday said it's requiring boxed warnings on hepatitis C medications called direct-acting antivirals, including Gilead Sciences Inc.'s Harvoni and Sovaldi and AbbVie Inc.'s Viekira Pak, warning that the medication can reactivate hepatitis B in patients who have previously had it.

Between Nov. 22, 2013, and July 18, 2016, there have been 24 cases reported to the FDA of hepatitis B reactivation in patients who were being treated with DAAs, leading to two deaths and one liver transplant, the agency said. The FDA said it doesn't know what's causing the negative reaction, and urged physicians to...

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