Drug Safety

, Volume 24, Issue 7, pp 483–490

Drug-Induced Liver Disorders

Implications for Drug Development and Regulation
Current Opinion

DOI: 10.2165/00002018-200124070-00001

Cite this article as:
Kaplowitz, N. Drug-Safety (2001) 24: 483. doi:10.2165/00002018-200124070-00001


Drug-induced hepatotoxicity is a frequent cause of liver disease. Although often presenting as acute hepatitis and/or cholestasis, virtually any clinicalpathological pattern of acute or chronic liver disease can occur. Most reactions occur in a small proportion of the population using a particular drug. Each drug associated with hepatotoxicity tends to have a characteristic signature regarding latency and pattern of injury. The mechanism can be drug metabolism-dependent or related to the chemical properties of the parent drug. The former are immune mediated or due to metabolic idiosyncrasy. Monitoring serum ALT levels is of unproven effectiveness but should be considered when there is an increased risk of delayed onset serious hepatitis-like reactions. The key for the future is improved identification of toxic potential in preclinical studies, clinical trials and postmarketing experience. The elucidation of the genetic and environmental mechanisms contributing to delayed idiosyncratic reactions is a major barrier to overcome in this field.

Copyright information

© Adis International Limited 2001

Authors and Affiliations

  1. 1.GI/Liver Division, USC Research Center for Liver Diseases, Keck School of MedicineUniversity of Southern CaliforniaLos AngelesUSA