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FDA warns about risks of incorrect dosing with obeticholic acid

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FDA warned Thursday that obeticholic acid (Ocaliva—Intercept Pharmaceuticals) is being incorrectly dosed in some patients with moderate-to-severe decreases in liver function, and that is leading to a higher risk of serious liver injury and death.

FDA warned Thursday that obeticholic acid (Ocaliva—Intercept Pharmaceuticals) is being incorrectly dosed in some patients with moderate-to-severe decreases in liver function, and that is leading to a higher risk of serious liver injury and death. Obeticholic acid is used to treat a rare, chronic liver disease known as primary biliary cholangitis. According to FDA, some individuals are receiving excessive dosing of the drug, particularly a higher frequency of dosing than is recommended on the drug label for them. The drug may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The current drug label includes the recommended dosing and monitoring for patients taking obeticholic acid. FDA said it is working with Intercept Pharmaceuticals to deal with these safety concerns. FDA called on health care professionals to determine the patient's baseline liver function prior to starting treatment with obeticholic acid; monitor patients frequently for disease progression; monitor frequently for liver injury; and education patients on the symptoms of potential liver injury. In addition, patients with moderate-to-severe liver impairment (Child-Pugh B and C) should be started on the approved dosing schedule of 5 mg once weekly, rather than the 5 mg daily dosing used for other PBC patients, and if needed, can be increased up to a maximum approved dose of 10 mg twice weekly. FDA's Drug Safety Communication on obeticholic acid is available here.

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https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm576861.htm

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