The FDA is warning that certain Hepatitis C medications can cause further damage to the livers of people with advanced cases of liver disease.
The new guidance specifically applies to patients with long-term, moderate to severe cases of liver disease.
The drugs Mavyret, Zepatier and Vosevi are approved to treat liver disease. However, new results show that using the drugs to treat advanced cases could, in some instances, lead to more damage or liver failure.
The FDA recommends that healthcare providers considering these treatments restrict them to patients with less serious cases of liver disease. Alternative treatments should be used for more severe cases.
To date, 63 cases have been identified in which the drugs caused increased liver damage or organ failure. Patients taking these medications should be monitored closely for signs of increasing damage.
The agency reports that in most cases, increased signs of liver damage ceased or reversed after patients stopped taking the drugs.
