The Assessment of Toxic Liver Injury

Kim, Dong Joon

Abstract

Liver injury due to prescription and nonprescription medications is a growing medical, scientific and public health problem. Drug-induced liver injury (DILI) is the single most common reason for regulatory actions, including failure of approval, removal from the marketplace and restriction of prescription. Worldwide, the estimated annual incidence rate of DILI is 13.9-24.0 per 100,000 inhabitants. At the same time, there is increasing concern about the potential risk for hepatotoxicity from complementary and alternative medicines (CAM) including herbal products because they are unregulated and not standardized with regard to their contents. Determining hepatotoxicity remains a major challenge in clinical practice due to a lack of reliable markers. The RUCAM/CIOMS scale have been proposed to establish a causal relationship between offending drug and liver injury. The efforts of Drug-Induced Liver Injury Network (DILIN, USA) directed toward the development of an abridged instrument in evaluating suspected drug-induced hepatotoxicity were presented at the National Institute of Health (NIH) Workshop, titled Drug-induced liver injury: Standardization of nomenclature and causality assessment, December, 2008. The main contents of the presentations and discussions at the NIH workshop are introduced in this article. This fine-tuned operations of RUCAM/CIOMS scale would enable a more confident assessment of causality and facilitate the collection of bona fide cases of drug-induced hepatotoxicity in Korea. Several demanding tasks for the near future in Korea are also proposed at the end.