title: Case definition and phenotype standardization in drug-induced liver injury.
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).
authors.affiliation: Nottingham Digestive Diseases Centre, National Institute for Health Research Biomedical Research Unit, Nottingham University Hospital National Health Service Trust, Nottingham, UK. Guru.Aithal@nuh.nhs.uk
authors.forename: G P
authors.initials: GP
authors.lastname: Aithal
authors.forename: P B
authors.initials: PB
authors.lastname: Watkins
authors.forename: R J
authors.initials: RJ
authors.lastname: Andrade
authors.forename: D
authors.initials: D
authors.lastname: Larrey
authors.forename: M
authors.initials: M
authors.lastname: Molokhia
authors.forename: H
authors.initials: H
authors.lastname: Takikawa
authors.forename: C M
authors.initials: CM
authors.lastname: Hunt
authors.forename: R A
authors.initials: RA
authors.lastname: Wilke
authors.forename: M
authors.initials: M
authors.lastname: Avigan
authors.forename: N
authors.initials: N
authors.lastname: Kaplowitz
authors.forename: E
authors.initials: E
authors.lastname: Bjornsson
authors.forename: A K
authors.initials: AK
authors.lastname: Daly
mesh_terms: D000410:Alanine Transaminase / Q000592:standards; D000818:Animals; D056486:Chemical and Drug Induced Liver Injury / Q000175:diagnosis* / Q000201:enzymology / Q000235:genetics*; D003937:Diagnosis, Differential; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D004364:Pharmaceutical Preparations / Q000097:blood / Q000592:standards*; D010641:Phenotype; D012015:Reference Standards; D009626:Terminology as Topic
chemical_list: D004364:Pharmaceutical Preparations; D000410:Alanine Transaminase