The FDA issued a Drug Safety Communication related to obeticholic acid (Ocaliva, Intercept), warning that the drug has been dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), increasing the risk for serious liver injury. The communication is an update to the MedWatch safety alert related to these concerns that was issued Sept. 21, 2017.
The FDA is clarifying the recommendations for patients with PBC and moderate to severe liver disease who are