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Rare occurrence of serious liver injury

USA. The US FDA has announced that it has received cases of worsening liver function or liver failure in patients taking hepatitis C medicines (Mavyret®, Zepatier® and Vosevi®).

Health-care professionals should continue to prescribe the medicines as indicated in the prescribing information for patients without liver impairment or with mild liver impairment. Also, they should assess severity of liver disease at baseline and closely monitor for signs and symptoms of worsening liver function such as an increase in liver enzymes, jaundice, ascites, encephalopathy and variceal hemorrhage. The medicines should be discontinued in patients who develop signs and symptoms of liver decompensation.

Reference: Safety Alerts for Human Medical Products, US FDA, 28 August 2019