FDA warns three Hepatitis C drugs may worsen liver function in some rare cases
pharmafile | August 29, 2019 | News story | Medical Communications, Research and Development | AbbVie, FDA, Gilead, HCV, MSD, hepatitis C, public health
The FDA has warned that three Hepatitis C (HCV) drugs made by AbbVie, Gilead and MSD are worsening liver function and causing liver failure in some patients.
The US regulator said it has identified 63 cases in which HCV drugs Mavyret, Zepatier, and Vosevi were worsening liver function in patients with symptoms of moderate-to-severe liver impairment and other serious liver problems.
While the FDA said the drugs are safe and effective, and that they should continue to be prescribed as indicated, the agency warned that in some rare cases the drugs posed serious health risks.
The agency noted that the drugs are indicated for patients without liver impairment or with mild liver impairment and that the drugs should be not used for patients with moderate-to-severe liver impairment.
Louis Goss
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