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RUCAM in Drug and Herb Induced Liver Injury: The Update

Danan, Gaby, Teschke, Rolf·2015·International Journal of Molecular Sciences
DOI 10.3390/ijms17010014PMC PMC4730261
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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.

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Sorted by citations

Metadata

Authors
Danan, G., & Teschke, R.
Affiliations
  • Pharmacovigilance Consultancy, rue des Ormeaux, 75020 Paris, France
  • 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
ORCID
Danan, Gaby
Venue
International Journal of Molecular Sciences
Publisher
MDPI AG
Published
2015-12-24
Volume
17
Issue
1
Pages
14
ISSN
1422-0067
DOI
10.3390/ijms17010014
PMC
PMC4730261
Cited by
729
References
5
Language
en
Licence
creativecommons.org/licenses/by/4.0/ (vor)

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