Drug-induced liver injury in clinical trials: as rare as hens' teeth

Am J Gastroenterol. 2009 May;104(5):1159-61. doi: 10.1038/ajg.2009.76. Epub 2009 Apr 7.

Abstract

Severe drug-induced liver injury is a relatively rare but important public health problem. Extrapolating the incidence of this problem from clinical treatment trials is confounded by a number of issues, including the relatively small size of clinical trials, exclusion criteria for study participation, and active surveillance for liver injury. Advances in understanding the pathogenesis of drug-induced liver injury, as well as its prevention and treatment, will likely require the identification and careful characterization of severe cases in the post-marketing, "real-world" setting as part of a concerted, multi-center, well-orchestrated effort. The Drug-Induced Liver Injury Network (DILIN) represents one example of such an effort.

Publication types

  • Editorial
  • Review
  • Comment

MeSH terms

  • Chemical and Drug Induced Liver Injury*
  • Clinical Trials as Topic*
  • Diclofenac / adverse effects*
  • Diclofenac / therapeutic use
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Incidence
  • Liver Diseases / epidemiology*
  • Liver Diseases / pathology
  • Liver Function Tests
  • Male
  • Rare Diseases
  • Risk Assessment
  • Severity of Illness Index
  • Survival Rate

Substances

  • Diclofenac