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Cited by 324

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Standardization of nomenclature and causality assessment in drug‐induced liver injury: Summary of a clinical research workshop†‡

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Fontana, Robert J., Seeff, Leonard B., Andrade, Raúl J., Björnsson, Einar, Day, Christopher P., Serrano, Jose, Hoofnagle, Jay H.·2010·Hepatology
DOI 10.1002/hep.23696
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Abstract

UNLABELLED: Idiosyncratic drug-induced liver injury (DILI) is an important but relatively infrequent cause of potentially severe acute and chronic liver injury. The aim of this clinical research workshop was to review and attempt to standardize the current nomenclature and terminology used in DILI research. Because DILI is a diagnosis of exclusion, selected elements of the medical history, laboratory tests, and previous reports were proposed to improve causality assessment. Definitions and diagnostic criteria regarding the onset of DILI, evolution of liver injury, risk factors, and mandatory testing versus optional testing for competing causes were reviewed. In addition, the role of intentional and inadvertent rechallenge, liver histology, and host genetic polymorphisms in establishing the diagnosis and prognosis of DILI were reviewed. Consensus was established regarding the need to develop a web-of-knowledge database that provides concise, reliable, and updated information on cases of liver injury due to drugs and herbal and dietary supplements. In addition, the need to develop drug-specific computerized causality assessment methods that are derived from prospectively phenotyped cases was a high priority. Proposed scales for grading DILI severity and assessing the likelihood of an agent causing DILI and written criteria for improving the reliability, accuracy, and reproducibility of expert opinion were reviewed. Finally, the unique challenges of assessing causality in children, patients with underlying liver disease, and subjects taking herbal and dietary supplements were discussed. CONCLUSION: Workshop participants concluded that multicenter referral networks enrolling patients with suspected DILI according to standardized methodologies are needed. These networks should also collect biological samples that may provide crucial insights into the mechanism(s) of DILI with the ultimate aim of preventing future cases of DILI.

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Metadata

Authors
Fontana, R. J., Seeff, L. B., Andrade, R. J., Björnsson, E., Day, C. P., Serrano, J., & Hoofnagle, J. H.
Venue
Hepatology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2010-08
Volume
52
Issue
2
Pages
730-742
ISSN
0270-9139 (ISSN-L)
DOI
10.1002/hep.23696
OpenAlex
W2014370035
Cited by
324
References
1
FWCI
20.54
Type
journal article
Language
en
Open access
bronze
Licence
doi.wiley.com/10.1002/tdm_license_1.1 (tdm, 1857 d)

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CoChat. (2026). Citation check: Standardization of nomenclature and causality assessment in drug‐induced liver injury: Summary of a clinical research workshop†‡. https://app.cochat.ai/papers/10.1002/hep.23696
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Fontana, R. J., Seeff, L. B., Andrade, R. J., Björnsson, E., Day, C. P., Serrano, J., & Hoofnagle, J. H. (2010). Standardization of nomenclature and causality assessment in drug‐induced liver injury: Summary of a clinical research workshop†‡. Hepatology. https://doi.org/10.1002/hep.23696

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