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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Human drug hepatotoxicity: a contemporary clinical perspective.
David Assis,Victor J. Navarro +1 more
TL;DR: The current clinical understanding of DILI including presentation patterns, causality assessment, risk factor ascertainment and early detection strategies including liver test monitoring are reviewed.
Journal ArticleDOI
Drug-induced liver injury: Is chronic liver disease a risk factor and a clinical issue?
Rolf Teschke,Gaby Danan +1 more
TL;DR: It is concluded that drugs seem to be well tolerated by the majority of patients with pre-existing, non-cirrhotic chronic liver diseases, however, special care is needed for some therapies, including antiviral therapy in chronic hepatitis B and C and in decompensated liver cirrhosis with impaired drug metabolism.
Journal ArticleDOI
Development and Validation of a Test to Identify Drugs That Cause Idiosyncratic Drug-Induced Liver Injury
Andreas Benesic,Isabelle Rotter,D Dragoi,Sabine Weber,Marie-Luise Buchholtz,Alexander L. Gerbes +5 more
TL;DR: The MH cell test could be a tool to identify causes of iDILI, even in patients taking multiple medications, based on their toxicity to monocyte‐derived hepatocyte‐like (MH) cells isolated from patients with DILI.
Journal ArticleDOI
Liver Safety in Patients with Type 2 Diabetes Treated with Pioglitazone: Results from a 3-Year, Randomized, Comparator-Controlled Study in the US
TL;DR: This study demonstrates an hepatic safety profile of pioglitazone similar to that of glibenclamide in long-term use in patients with poorly controlled type 2 diabetes.
Journal ArticleDOI
Valproate for agitation in critically ill patients: A retrospective study.
David R. Gagnon,Gabriel V. Fontaine,Kathryn Smith,Richard R. Riker,Russell R. Miller,Patricia Lerwick,Francis Lucas,John Dziodzio,Kristen C. Sihler,Gilles L. Fraser +9 more
TL;DR: Valproate therapy was associated with a reduction in agitation, delirium, and concomitant psychoactive medication use within 48 hours of initiation.
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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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