The U.S. Food and Drug Administration (FDA) has ordered a boxed warning and dosing table be added to the liver disease drug Ocaliva (obeticholic acid) following reports that the medication is being incorrectly dosed daily instead of weekly to patients.
Medscape reports that Ocaliva is prescribed to patients with moderate to severe primary billary cholangitis (PBC) and that the incorrect dosing results in an significantly increased risk of serious liver injury.
In a safety communication, the FDA addressed the issue saying that the dosing errors have resulted in cases of liver decompensation, liver failure, and death. In order to correct the issue, the FDA is clarifying current recommendations for screening, dosing, monitoring, and managing PBC in patients with moderate to severe liver disease taking Ocaliva.
In addition to the boxed warning and dosing table, the FDA said that it will also require Ocaliva carry a medication guide for patients that informs them about the past dosing issues and the risk of such errors.
Beyond packaging and label changes, the FDA advises clinicians to take the following actions when treating a patient with Ocaliva:
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