Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Serious Liver Injury Being Observed in Patients without Cirrhosis

Based on its review of postmarket clinical trial data, the U.S. Food and Drug Administration (FDA) identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver.

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