The Food and Drug Administration advised on Sept. 21 that incorrect excessive dosing of the liver disease medicine obeticholic acid (Ocaliva) creates an increased risk of serious liver injury and death. The agency recommends closer monitoring of dosages and following the current label’s recommendations.
Obeticholic acid is used to treat primary biliary cholangitis. Patients taking the drug should first be tested for their baseline liver function so that the effects of the drug can be monitored. The level of liver impairment determines the recommended dosage: Those with moderate to severe impairment should start by taking 5 mg weekly (with a possible increase to 10 mg weekly) instead of the standard 5 mg daily. Those who start at the standard dose and progress to moderate or severe liver impairment can have their dosage reduced or can discontinue the drug altogether.
The FDA has identified cases of serious liver injury and death associated with obeticholic acid use since the agency approved the drug in May 2016, including at least seven cases in which patients with moderate to severe liver impairment were taking the excessive 5-mg daily dose (for their condition) and died.