FDA In Brief: FDA warns patients and health care professionals about rare instances of serious liver injury or failure with certain hepatitis C treatments in some patients with advanced liver disease

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-warns-patients-and-health-care-professionals-about-rare-instances-serious-liver-injury?utm_campaign=082819_FIB_FDA%20warns%20about%20rare%20cases%20of%20serious%20liver%20injury%20or%20failure-Hep%20C&utm_medium=email&utm_source=Eloqua

FDA In Brief: FDA warns patients and health care professionals about rare instances of serious liver injury or failure with certain hepatitis C treatments in some patients with advanced liver disease

The U.S. Food and Drug Administration has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C (HCV) in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. These medicines are not indicated for use in patients with moderate to severe liver impairment, but are safe and effective in patients with no or mild liver impairment. Through reports submitted to the FDA as well as other sources, the agency identified 63 cases of worsening liver function, called decompensation, some leading to liver failure or death, in patients using Mavyret, Zepatier and Vosevi. In many of the reported cases, liver failure occurred in patients who had signs and symptoms of moderate-to-severe liver disease or other serious liver problems and should not have been treated with these medicines. In some cases, patients were reported as having no cirrhosis, or liver scarring, or cirrhosis with mild liver impairment (compensated cirrhosis) but had indications of ...

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