The liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. Intercept gave healthcare providers prescribing information for Ocaliva and flagged reports of liver failure and deaths. Two weeks later, the FDA released a black box warning. A black box warning is the strictest warning by the FDA that appears on a prescription drug's label, calling attention to serious or life-threatening risks of a drug.
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