Unresolved Issues of Drug-Induced Liver Injury

Kim, Dong Joon

Abstract

Liver injury due to prescription and nonprescription medications is a growing medical, scientific, and public health problem. Worldwide, the estimated annual incidence rate of Drug-induced liver injury (DILI) is 13.9-24.0 per 100,000 inhabitants. And there is increasing concern about the potential risk for hepatotoxicity from complementary and alternative medicines (CAM) including herbal products because they are unregulated and therefore not standardized with regard to their contents. CAM, including herbal drugs and dietary supplements seem to be major causes of DILI in Asian countries, in contrast to lower incidences in Western countries. However, with increasing use of CAM, DILI from CAM seems to now be a problem all over the world. The classification and definition of the causative agents can be difficult. For example, in Korea, herbs might sub-categorize into herbal medications (medications prescribed and compounded by a doctor of oriental medicine), herbal preparations (preparations compounded by an oriental pharmacist), and medicinal herbs or plants (preparation compounded by an unauthorized lay person). Also the division of herbs and folk remedies is unclear at times. Determining hepatotoxicity remains a major challenge in clinical practice due to lack of reliable markers. Standards are lacking for validation of drug causality assessment methods. The RUCAM/CIOMS scale have been proposed to establish a causal relationship between offending drug and liver injury. Although, there is a need to validate a new instrument with an abridged scale that would provide a better approximation to the truth. It would be feasible to develop some refinements to make the RUCAM/CIOMS scale more realistic.