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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
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Hepatotoxicity induced by herbal and dietary supplements
Victor J Navarro1, M Isabel Lucena2
1Division of Hepatology, Einstein Medical Center, Philadelphia, Pennsylvania.
Seminars in Liver Disease
|June 1, 2014
Summary
Herbals and dietary supplements (HDS) can cause liver injury, with unknown incidence and severe outcomes. Diagnosis and causality assessment are challenging, necessitating further research into epidemiology and contributing factors.
Area of Science:
- Hepatology
- Toxicology
- Pharmacovigilance
Background:
- Herbals and dietary supplements (HDS) pose a risk of drug-induced liver injury (DILI).
- Global regulatory frameworks for HDS, including the US and Europe, have limitations in ensuring premarket safety.
- The actual prevalence and clinical spectrum of HDS-induced hepatotoxicity remain largely uncharacterized.
Purpose of the Study:
- To review the current understanding of hepatotoxicity associated with herbals and dietary supplements.
- To discuss diagnostic challenges, causality assessment methods, and regulatory aspects.
- To highlight areas for future research in HDS-induced liver injury.
Main Methods:
- Review of existing literature on HDS-induced hepatotoxicity.
- Discussion of diagnostic criteria and causality assessment tools, specifically the Roussel Uclaf Causality Assessment Method (RUCMAM).
- Analysis of current regulatory landscapes in the US and Europe concerning HDS.
Main Results:
- Hepatotoxicity from HDS typically presents with a hepatocellular enzyme pattern and can lead to severe outcomes, including liver transplantation.
- Accurate diagnosis is often hindered by underreporting of HDS use by patients.
- No single causality assessment method is ideal, though RUCMAM is frequently employed.
Conclusions:
- HDS-induced hepatotoxicity is a significant clinical concern with unknown incidence and variable severity.
- Improved methods for diagnosis, causality assessment, and regulatory oversight are crucial.
- Future research should prioritize epidemiological studies, standardized nomenclature, identification of causative agents, host factors, and biomarkers.
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