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Drug-Induced Liver Toxicity pp 555–594Cite as

Causality Assessment Methods in Drug-Induced Liver Injury

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Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

Abstract

A robust causality assessment method (CAM) is not only indispensable for the diagnosis of suspected drug-induced liver injury (DILI) and herb-induced liver injury (HILI) but is also critical for the investigation of the clinical features, risk factors, and incidence in pharmacological or epidemiological studies. RUCAM (Roussel Uclaf Causality Assessment Method) is the most widely used CAM in suspected DILI and HILI cases worldwide, as evidenced by its application in a large number of case reports and case series since RUCAM was first published in 1993. It offers a structured, standardized diagnostic approach specific to liver injury by attributing scores to individual key items that provide final quantitative gradings of causality. In many countries and for more than two decades, physicians, regulatory agencies, case report authors, and pharmaceutical companies have successfully applied this well-validated CAM. The RUCAM update in 2016 clarified a few complicated items such as alcohol use and exclusion of nondrug causes. The intention of this approach was to provide accurately defined and objective core elements to simplify item handling, and therefore reduce interobserver and intraobserver variability. In conclusion, RUCAM should be recommended as the preferred CAM for suspected DILI and HILI cases.

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Authors and Affiliations

  1. Division of Gastroenterology and Hepatology, Department of Internal Medicine II, Klinikum Hanau, Hanau, Germany

    Rolf Teschke

  2. Academic Teaching Hospital of the Medical Faculty, Goethe University Frankfurt/Main, Frankfurt am Main, Germany

    Rolf Teschke

  3. Pharmacovigilance Consultancy, Paris, France

    Gaby Danan

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  1. Rolf Teschke
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  2. Gaby Danan
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Correspondence to Rolf Teschke .

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Editors and Affiliations

  1. Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, USA

    Minjun Chen

  2. Drug Safety Research and Development, Pfizer Inc., Groton, CT, USA

    Yvonne Will

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Teschke, R., Danan, G. (2018). Causality Assessment Methods in Drug-Induced Liver Injury. In: Chen, M., Will, Y. (eds) Drug-Induced Liver Toxicity. Methods in Pharmacology and Toxicology. Humana, New York, NY. https://doi.org/10.1007/978-1-4939-7677-5_27

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