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RUCAM in Drug and Herb Induced Liver Injury: The Update.
Int J Mol Sci 2015; 17(1)IJ

Abstract

RUCAM (Roussel Uclaf Causality Assessment Method) or its previous synonym CIOMS (Council for International Organizations of Medical Sciences) is a well established tool in common use to quantitatively assess causality in cases of suspected drug induced liver injury (DILI) and herb induced liver injury (HILI). Historical background and the original work confirm the use of RUCAM as single term for future cases, dismissing now the term CIOMS for reasons of simplicity and clarity. RUCAM represents a structured, standardized, validated, and hepatotoxicity specific diagnostic approach that attributes scores to individual key items, providing final quantitative gradings of causality for each suspect drug/herb in a case report. Experts from Europe and the United States had previously established in consensus meetings the first criteria of RUCAM to meet the requirements of clinicians and practitioners in care for their patients with suspected DILI and HILI. RUCAM was completed by additional criteria and validated, assisting to establish the timely diagnosis with a high degree of certainty. In many countries and for more than two decades, physicians, regulatory agencies, case report authors, and pharmaceutical companies successfully applied RUCAM for suspected DILI and HILI. Their practical experience, emerging new data on DILI and HILI characteristics, and few ambiguous questions in domains such alcohol use and exclusions of non-drug causes led to the present update of RUCAM. The aim was to reduce interobserver and intraobserver variability, to provide accurately defined, objective core elements, and to simplify the handling of the items. We now present the update of the well accepted original RUCAM scale and recommend its use for clinical, regulatory, publication, and expert purposes to validly establish causality in cases of suspected DILI and HILI, facilitating a straightforward application and an internationally harmonized approach of causality assessment as a common basic tool.

Authors+Show Affiliations

Pharmacovigilance Consultancy, rue des Ormeaux, 75020 Paris, France. gaby.danan@gmail.com.Department of Internal Medicine II, Division of Gastroenterology and Hepatology, Klinikum Hanau, Academic Teaching Hospital of the Medical Faculty, Goethe University Frankfurt/Main, Frankfurt am Main, D-63450 Hanau, Germany. rolf.teschke@gmx.de.

Pub Type(s)

Comparative Study
Journal Article
Review

Language

eng

PubMed ID

26712744

Citation

Danan, Gaby, and Rolf Teschke. "RUCAM in Drug and Herb Induced Liver Injury: the Update." International Journal of Molecular Sciences, vol. 17, no. 1, 2015.
Danan G, Teschke R. RUCAM in Drug and Herb Induced Liver Injury: The Update. Int J Mol Sci. 2015;17(1).
Danan, G., & Teschke, R. (2015). RUCAM in Drug and Herb Induced Liver Injury: The Update. International Journal of Molecular Sciences, 17(1), doi:10.3390/ijms17010014.
Danan G, Teschke R. RUCAM in Drug and Herb Induced Liver Injury: the Update. Int J Mol Sci. 2015 Dec 24;17(1) PubMed PMID: 26712744.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - RUCAM in Drug and Herb Induced Liver Injury: The Update. AU - Danan,Gaby, AU - Teschke,Rolf, Y1 - 2015/12/24/ PY - 2015/11/07/received PY - 2015/12/07/revised PY - 2015/12/09/accepted PY - 2015/12/30/entrez PY - 2015/12/30/pubmed PY - 2016/10/21/medline KW - CIOMS KW - RUCAM KW - causality assessment KW - dietary supplements KW - drug hepatotoxicity KW - drug induced liver injury KW - drugs KW - herb induced liver injury KW - herbal hepatotoxicity KW - herbs JF - International journal of molecular sciences JO - Int J Mol Sci VL - 17 IS - 1 N2 - RUCAM (Roussel Uclaf Causality Assessment Method) or its previous synonym CIOMS (Council for International Organizations of Medical Sciences) is a well established tool in common use to quantitatively assess causality in cases of suspected drug induced liver injury (DILI) and herb induced liver injury (HILI). Historical background and the original work confirm the use of RUCAM as single term for future cases, dismissing now the term CIOMS for reasons of simplicity and clarity. RUCAM represents a structured, standardized, validated, and hepatotoxicity specific diagnostic approach that attributes scores to individual key items, providing final quantitative gradings of causality for each suspect drug/herb in a case report. Experts from Europe and the United States had previously established in consensus meetings the first criteria of RUCAM to meet the requirements of clinicians and practitioners in care for their patients with suspected DILI and HILI. RUCAM was completed by additional criteria and validated, assisting to establish the timely diagnosis with a high degree of certainty. In many countries and for more than two decades, physicians, regulatory agencies, case report authors, and pharmaceutical companies successfully applied RUCAM for suspected DILI and HILI. Their practical experience, emerging new data on DILI and HILI characteristics, and few ambiguous questions in domains such alcohol use and exclusions of non-drug causes led to the present update of RUCAM. The aim was to reduce interobserver and intraobserver variability, to provide accurately defined, objective core elements, and to simplify the handling of the items. We now present the update of the well accepted original RUCAM scale and recommend its use for clinical, regulatory, publication, and expert purposes to validly establish causality in cases of suspected DILI and HILI, facilitating a straightforward application and an internationally harmonized approach of causality assessment as a common basic tool. SN - 1422-0067 UR - https://www.unboundmedicine.com/medline/citation/26712744/RUCAM_in_Drug_and_Herb_Induced_Liver_Injury:_The_Update_ L2 - http://www.mdpi.com/resolver?pii=ijms17010014 DB - PRIME DP - Unbound Medicine ER -