FDA issues warning on Ocaliva death threat

The US Food and Drug Administration (FDA) is warning that the liver disease drug Ocaliva (obeticholic acid) is being incorrectly dosed in some patients, causing an increased risk of serious liver injury and death.

Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose, the FDA warns. The agency is working with the drug manufacturer, USA-based Intercept Pharmaceuticals (Nasdaq: ICPT), to address the safety concerns.