DILI is broadly categorized into intrinsic and idiosyncratic types. Intrinsic hepatotoxins, such as APAP, cause dose-dependent injury, while idiosyncratic DILI involves complex immune and metabolic interactions that remain poorly understood.

Intercept Pharmaceuticals' liver disease drug is being observed for injury to the organ in patients without severe scarring, the U.S. Food and Drug Administration said on Thursday, based on its review of post-market clinical trial data.

The agency identified 20 cases of serious liver damage associated with Ocaliva in the latest setback for a drug once seen as a potential blockbuster.