Drug-induced liver injury, mortality, and liver transplantation: is it reasonable to use a global introspection causality assessment?

Drug-induced liver injury (DILI) is a challenging topic in hepatology, with high expectations on studies bringing additional data in support of disease characterization. At least since 2005 it has been documented that a majority but not all patients with DILI recover from their disease following drug cessation. Indeed, a fatality rate around 10% is expected among patients who were studied for the first 6 months. In 2017, this knowledge stimulated Hayashi et al. (1) to analyze the fatality rate of DILI patients within two years after DILI onset. With a fatality rate of 9.8%, the online study under discussion showed similar results (1) and confirmed data on the first six months from two large European registries in 2005 (2,3). These two pioneering reports were based on DILI cases from Spain (2) and Sweden (3). Both groups used Roussel Uclaf Causality Assessment Method (RUCAM) (4,5) to validly and objectively assess causality (2,3). With conclusions based on results using global introspection, the study under discussion provides data raising questions (1). These focus on causality assessment methods of DILI cases and point out other aspects of interest that merit consideration.