UNLABELLED: Idiosyncratic drug-induced liver injury (DILI) is an important but relatively infrequent cause of potentially severe acute and chronic liver injury. The aim of this clinical research workshop was to review and attempt to standardize the current nomenclature and terminology used in DILI research. Because DILI is a diagnosis of exclusion, selected elements of the medical history, laboratory tests, and previous reports were proposed to improve causality assessment. Definitions and diagnostic criteria regarding the onset of DILI, evolution of liver injury, risk factors, and mandatory testing versus optional testing for competing causes were reviewed. In addition, the role of intentional and inadvertent rechallenge, liver histology, and host genetic polymorphisms in establishing the diagnosis and prognosis of DILI were reviewed. Consensus was established regarding the need to develop a web-of-knowledge database that provides concise, reliable, and updated information on cases of liver injury due to drugs and herbal and dietary supplements. In addition, the need to develop drug-specific computerized causality assessment methods that are derived from prospectively phenotyped cases was a high priority. Proposed scales for grading DILI severity and assessing the likelihood of an agent causing DILI and written criteria for improving the reliability, accuracy, and reproducibility of expert opinion were reviewed. Finally, the unique challenges of assessing causality in children, patients with underlying liver disease, and subjects taking herbal and dietary supplements were discussed. CONCLUSION: Workshop participants concluded that multicenter referral networks enrolling patients with suspected DILI according to standardized methodologies are needed. These networks should also collect biological samples that may provide crucial insights into the mechanism(s) of DILI with the ultimate aim of preventing future cases of DILI.
UNLABELLED: Idiosyncratic drug-induced liver injury (DILI) is an important but relatively infrequent cause of potentially severe acute and chronic liver injury. The aim of this clinical research workshop was to review and attempt to standardize the current nomenclature and terminology used in DILI research. Because DILI is a diagnosis of exclusion, selected elements of the medical history, laboratory tests, and previous reports were proposed to improve causality assessment. Definitions and diagnostic criteria regarding the onset of DILI, evolution of liver injury, risk factors, and mandatory testing versus optional testing for competing causes were reviewed. In addition, the role of intentional and inadvertent rechallenge, liver histology, and host genetic polymorphisms in establishing the diagnosis and prognosis of DILI were reviewed. Consensus was established regarding the need to develop a web-of-knowledge database that provides concise, reliable, and updated information on cases of liver injury due to drugs and herbal and dietary supplements. In addition, the need to develop drug-specific computerized causality assessment methods that are derived from prospectively phenotyped cases was a high priority. Proposed scales for grading DILI severity and assessing the likelihood of an agent causing DILI and written criteria for improving the reliability, accuracy, and reproducibility of expert opinion were reviewed. Finally, the unique challenges of assessing causality in children, patients with underlying liver disease, and subjects taking herbal and dietary supplements were discussed. CONCLUSION: Workshop participants concluded that multicenter referral networks enrolling patients with suspected DILI according to standardized methodologies are needed. These networks should also collect biological samples that may provide crucial insights into the mechanism(s) of DILI with the ultimate aim of preventing future cases of DILI.
Authors: M García-Cortés; M I Lucena; K Pachkoria; Y Borraz; R Hidalgo; R J Andrade Journal: Aliment Pharmacol Ther Date: 2008-02-18 Impact factor: 8.171
Authors: Jin Bae Kim; Joo Hyun Sohn; Hang Lak Lee; Jong Pyo Kim; Dong Soo Han; Joon Soo Hahm; Dong Hoo Lee; Chun Suhk Kee Journal: Korean J Hepatol Date: 2004-06
Authors: Julie I Papay; Dawn Clines; Rezvan Rafi; Nancy Yuen; Susan D Britt; John S Walsh; Christine M Hunt Journal: Regul Toxicol Pharmacol Date: 2009-03-18 Impact factor: 3.271
Authors: Kennon Heard; Alison Bui; Sara L Mlynarchek; Jody L Green; G Randall Bond; Richard F Clark; Eran Kozer; Raymond S Koff; Richard C Dart Journal: Am J Ther Date: 2014 May-Jun Impact factor: 2.688
Authors: Robert J Fontana; Paul H Hayashi; Jiezhun Gu; K Rajender Reddy; Huiman Barnhart; Paul B Watkins; Jose Serrano; William M Lee; Naga Chalasani; Andrew Stolz; Timothy Davern; Jayant A Talwakar Journal: Gastroenterology Date: 2014-03-27 Impact factor: 22.682
Authors: Allen D Brinker; Jenna Lyndly; Joseph Tonning; David Moeny; Jonathan G Levine; Mark I Avigan Journal: Drug Saf Date: 2013-12 Impact factor: 5.606
Authors: Rolf Teschke; Albrecht Wolff; Christian Frenzel; Alexander Schwarzenboeck; Johannes Schulze; Axel Eickhoff Journal: World J Hepatol Date: 2014-01-27
Authors: Sven Schmiedl; Marietta Rottenkolber; Jacek Szymanski; Werner Siegmund; Marion Hippius; Katrin Farker; Bernd Drewelow; Joerg Hasford; Petra Thürmann Journal: Dtsch Arztebl Int Date: 2013-04-05 Impact factor: 5.594