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FDA adds Boxed Warning to highlight correct dosing of obeticholic acid for patients with PBC

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eMediNexus    02 February 2018

In a safety communication, the US Food and Drug Administration (FDA) has warned that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC) increasing the risk of serious liver injury. The FDA has added a new Boxed Warning to highlight current recommendations for screening, dosing, monitoring, and managing these patients in the prescribing information of the drug label.

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