Journal ArticleDOI
Causality assessment of adverse reactions to drugs--I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries.
Gaby Danan,Christian Bénichou +1 more
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In this paper, a new method for drug causality assessment is described and applied to reports of acute liver injuries, using reports with positive rechallenge as external standard.About:
This article is published in Journal of Clinical Epidemiology.The article was published on 1993-11-01. It has received 1291 citations till now. The article focuses on the topics: Adverse drug reaction.read more
Citations
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Genetic Polymorphisms of SLCO1B1, CYP2E1 and UGT1A1 and Susceptibility to Anti-Tuberculosis Drug-Induced Hepatotoxicity: A Chinese Population-Based Prospective Case-Control Study.
TL;DR: Genetic polymorphisms of SLCO1B1 and UGT1A1 were found to be associated with susceptibility to ATDH, providing a theoretical foundation for predicting the likelihood of ATDH and predicting treatment outcomes in tuberculosis patients.
Journal ArticleDOI
Concentrated green tea extract induces severe acute hepatitis in a 63-year-old woman--a case report with pharmaceutical analysis.
Mike H. Pillukat,Carolin Bester,Andreas Hensel,Matthias Lechtenberg,Frank Petereit,Susanne Beckebaum,Klaus-Michael Müller,Hartmut Schmidt +7 more
TL;DR: A typical reversible course of severe hepatitis after green tea consumption is presented in a 63-year old woman during treatment with green tea-capsules upon recommendation of a cancer support group and underlines the importance of public awareness in the potential risks in use of herbal products.
Journal ArticleDOI
Pexidartinib Long-Term Hepatic Safety Profile in Patients with Tenosynovial Giant Cell Tumors.
James H. Lewis,Hans Gelderblom,Michiel A. J. van de Sande,Silvia Stacchiotti,John H. Healey,William D. Tap,Andrew J. Wagner,Antonio López Pousa,Mihaela Druta,Chia-Chi Lin,Hideo A. Baba,Youngsook Choi,Qiang Wang,Dale Shuster,Sebastian Bauer +14 more
TL;DR: Long-term treatment with pexidartinib has a predictable effect on hepatic aminotransferases and unpredictable risk of serious cholestatic or mixed liver injury, and this pooled analysis provides information to help form the basis for the treating physician's risk assessment for patients with TCGT.
Journal ArticleDOI
Comparison of three pharmacovigilance algorithms in the ICU setting: a retrospective and prospective evaluation of ADRs.
Sandra L. Kane-Gill,Elizabeth A. Forsberg,Margaret M. Verrico,Steven M. Handler,Steven M. Handler +4 more
TL;DR: These instruments demonstrated similar results for evaluating ADRs in the ICU retrospectively, suggesting that instrument selection with any of the three instruments is reasonable.
Journal ArticleDOI
Drug-induced hepatotoxicity: incidence of abnormal liver function tests consistent with volatile anaesthetic hepatitis in trauma patients.
Jonathan Lin,David Moore,Brad Hockey,Rachel Di Lernia,Alexandra Gorelik,Danny Liew,Amanda Nicoll +6 more
TL;DR: How common liver injury consistent with volatile anaesthetic hepatitis is, following exposure to isoflurane, desflurane and sevofl Lurane is determined, and risk factors for its development are proposed.
References
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Journal Article
Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France
Journal ArticleDOI
Causality assessment of adverse reactions to drugs--II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge.
TL;DR: It is concluded that adverse drug reaction reports with a positive rechallenge can provide a standard for validation of causality assessment methods, and RUCAM applied to drug-induced liver injuries has been validated.
Journal ArticleDOI
An Algorithm for the Operational Assessment of Adverse Drug Reactions: I. Background, Description, and Instructions for Use
TL;DR: An algorithm is developed that provides detailed operational criteria for ranking the probability of causation when ADR is suspected between a drug and a clinical manifestation.
Journal ArticleDOI
Toward the operational identification of adverse drug reactions.
Fred E. Karch,Louis Lasagna +1 more
TL;DR: A decision table algorithm approach is presented toward the development of an operational system for the identification of adverse drug reactions that incorporates an estimate of the certainty of the link between the untoward clinical event and the suspect drug, and examines the underlying causes of the identified drug reactions.
Journal ArticleDOI
Assessing methods for causality assessment of suspected adverse drug reactions
Tom A. Hutchinson,David A. Lane +1 more
TL;DR: Six alternative criteria are described that attempt to address a potential user's main concerns--the need to know whether to believe the results in general and in a particular case and focus on the internal structure of a method rather than its output.
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Drug-Induced Liver Injury: An Analysis of 461 Incidences Submitted to the Spanish Registry Over a 10-Year Period
Raúl J. Andrade,M. Isabel Lucena,M. Carmen Fernández,G. Pelaez,Ketevan Pachkoria,Elena García-Ruiz,B. García-Muñoz,Rocío González-Grande,Angeles Pizarro,José Antonio Durán,Manuel Jimenez,Luis Rodrigo,Manuel Romero-Gómez,J.M. Navarro,Ramon Planas,Joan Costa,Africa Borras,Aina Soler,Javier Salmerón,Rafael Martín-Vivaldi +19 more