Liver Injury in Patients With Cholestatic Liver Disease Treated With Obeticholic Acid

Obeticholic acid (OCA) was approved for the treatment of primary biliary cholangitis (PBC) based on studies in patients with an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) or elevated total bilirubin less than 2 times ULN.1 Postmarket reports of serious liver injury in patients receiving OCA prompted a boxed warning by the Food and Drug Administration (FDA). Drug-induced liver injury (DILI) in patients with PBC can put them at risk for acute on chronic liver failure (ACLF) and increased mortality.2 We describe in this report worsening of liver disease or ACLF after starting OCA among a cohort of patients with PBC and primary sclerosing cholangitis (PSC).