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Case Definition and Phenotype Standardization in Drug-Induced Liver Injury

Lookup NU author(s): Professor Ann DalyORCiD

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Abstract

Drug-induced liver injury (DILI) is the most frequent reason cited for the withdrawal of approved drugs from the market and accounts for up to 15% of the cases of acute liver failure. Investigators around the globe have begun to identify and study patients with DILI; several large registries and tissue banks are being established. In order to gain the maximum scientific benefit from these efforts, the definitions and terminology related to the clinical phenotypes of DILI must be harmonized. For this purpose, an international DILI Expert Working Group of clinicians and scientists reviewed current DILI terminology and diagnostic criteria so as to develop more uniform criteria that would define and characterize the spectrum of clinical syndromes that constitute DILI. Consensus was established with respect to the threshold criteria for definition of a case as being DILI, the pattern of liver injury, causality assessment, severity, and chronicity. Consensus was also reached on approaches to characterizing DILI in the setting of chronic liver diseases, including autoimmune hepatitis (AIH).

Publication metadata

Author(s): Aithal GP, Watkins PB, Andrade RJ, Larrey D, Molokhia M, Takikawa H, Hunt CM, Wilke RA, Avigan M, Kaplowitz N, Bjornsson E, Daly AK

Publication type: Article

Publication status: Published

Journal: Clinical Pharmacology & Therapeutics

Year: 2011

Volume: 89

Issue: 6

Pages: 806-815

Print publication date: 04/05/2011

ISSN (print): 0009-9236

ISSN (electronic): 1532-6535

Publisher: Nature Publishing Group

URL: http://dx.doi.org/10.1038/clpt.2011.58

DOI: 10.1038/clpt.2011.58

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