Autoimmune/Cholestatic/Biliary Diseases

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FDA: Patients receiving incorrect Ocaliva dosage, reports of liver injury

September 21, 2017

The FDA released a report today that Ocaliva has been incorrectly prescribed to some patients with moderate to severe liver impairment and may be tied to cases of liver injury and death.

“These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them,” the FDA stated in their report. “Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label. We are working with the drug manufacturer, Intercept Pharmaceuticals, to address these safety concerns.”

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