EMA Committee Urges Warning About Hep B Reactivation In Patients Taking DAAs
The European Medicines Agency’s pharmacovigilance committee wants manufacturers of the direct-acting antivirals for hepatitis C to include a warning about the possibility of hepatitis B reactivation in patients who carry both viruses.
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FDA imposes boxed warning on labels for hepatitis C drugs in response to reports of hepatitis B reactivation, including fatal cases.
The European Medicines Agency has begun a review of the direct-acting antivirals (DAAs) for hepatitis C in light of a number of recent cases showing that hepatitis B virus has been reactivated in some HCV patients treated with the newer products1.
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