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Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop.
Hepatology. 2010 Aug; 52(2):730-42.Hep

Abstract

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.

Authors+Show Affiliations

Department of Internal Medicine, University of Michigan, Ann Arbor, MI 48103, USA. rfontana@med.umich.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Congress
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20564754

Citation

Fontana, Robert J., et al. "Standardization of Nomenclature and Causality Assessment in Drug-induced Liver Injury: Summary of a Clinical Research Workshop." Hepatology (Baltimore, Md.), vol. 52, no. 2, 2010, pp. 730-42.
Fontana RJ, Seeff LB, Andrade RJ, et al. Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop. Hepatology. 2010;52(2):730-42.
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 (Baltimore, Md.), 52(2), 730-42. https://doi.org/10.1002/hep.23696
Fontana RJ, et al. Standardization of Nomenclature and Causality Assessment in Drug-induced Liver Injury: Summary of a Clinical Research Workshop. Hepatology. 2010;52(2):730-42. PubMed PMID: 20564754.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop. AU - Fontana,Robert J, AU - Seeff,Leonard B, AU - Andrade,Raúl J, AU - Björnsson,Einar, AU - Day,Christopher P, AU - Serrano,Jose, AU - Hoofnagle,Jay H, PY - 2010/6/22/entrez PY - 2010/6/22/pubmed PY - 2010/9/8/medline SP - 730 EP - 42 JF - Hepatology (Baltimore, Md.) JO - Hepatology VL - 52 IS - 2 N2 - 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. SN - 1527-3350 UR - https://www.unboundmedicine.com/medline/citation/20564754/Standardization_of_nomenclature_and_causality_assessment_in_drug_induced_liver_injury:_summary_of_a_clinical_research_workshop_ L2 - https://doi.org/10.1002/hep.23696 DB - PRIME DP - Unbound Medicine ER -