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Updated: Jun 26, 2026
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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Monitoring for hepatotoxicity: what is the predictive value of liver "function" tests?
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
Summary
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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