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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
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Monitoring for hepatotoxicity: what is the predictive value of liver "function" tests?

J R Senior1

  • 1Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA. john.senior@fda.hhs.gov

Clinical Pharmacology and Therapeutics
|January 9, 2009
PubMed

Insights

Drug-induced liver injury (DILI) monitoring is often ineffective and poorly followed. This review questions its utility and explores alternative strategies for preventing hepatotoxicity.

Area of Science:

  • Pharmacology
  • Hepatology
  • Drug Development

Background:

  • Drug-induced liver injury (DILI) is a significant cause of drug attrition during development and post-market withdrawal.
  • Current monitoring strategies for drug-induced hepatotoxicity are often inconvenient and poorly adhered to by patients and clinicians.
  • The effectiveness of existing monitoring protocols in preventing DILI is questionable.

Purpose of the Study:

  • To critically evaluate the efficacy of current serum enzyme monitoring for preventing DILI.
  • To determine if monitoring recommendations are evidence-based or opinion-driven.
  • To identify and assess potential alternative strategies for DILI prevention.

Main Methods:

  • Literature review and critical analysis of existing studies on DILI.
  • Examination of drug labeling recommendations for hepatotoxicity monitoring.
  • Comparative assessment of monitoring effectiveness versus alternative approaches.

Main Results:

  • Existing monitoring practices for DILI are frequently not followed, limiting their effectiveness.
  • Evidence supporting the data-driven basis of many monitoring recommendations is often lacking.
  • The inconvenience and inefficiency of current monitoring contribute to poor compliance.

Conclusions:

  • Current serum enzyme monitoring strategies for DILI are of questionable value and poorly implemented.
  • A re-evaluation of DILI monitoring practices is necessary, prioritizing patient adherence and clinical utility.
  • Development and validation of alternative, more effective DILI prevention strategies are warranted.

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