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.
TLDR
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.About:
This article is published in Journal of Clinical Epidemiology.The article was published on 1993-11-01. It has received 494 citations till now.read more
Citations
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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
TL;DR: 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.
Journal ArticleDOI
Drug-Related Hepatotoxicity
Victor J. Navarro,John R. Senior +1 more
TL;DR: Clinical guidance is provided with regard to the detection, evaluation, and possible prevention of drug-related hepatotoxicity in patients exposed to hepatotoxic effects of new medication.
Journal ArticleDOI
Causes, Clinical Features, and Outcomes From a Prospective Study of Drug-Induced Liver Injury in the United States
Naga Chalasani,Robert J. Fontana,Herbert L. Bonkovsky,Herbert L. Bonkovsky,Herbert L. Bonkovsky,Paul B. Watkins,Timothy J. Davern,Jose Serrano,Hongqiu Yang,James Rochon +9 more
TL;DR: This report summarizes the causes, clinical features, and outcomes from the first 300 patients enrolled in a prospective study to recruit patients with suspected idiosyncratic drug-induced liver injury and create a repository of biological samples for analysis.
Journal Article
Drug-induced hepatotoxicity.
Raúl J. Andrade,M.I. Lucena +1 more
TL;DR: The influence of older age in the cholestatic/mixed expression of the liver injury, as well as the independent association of female gender, older age, aspartate aminotransferase levels/hepatocellular type of damage and high bilirubin levels with the risk of fulminant liver failure/death are underlined.
References
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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
TL;DR: 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.
Journal Article
Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France
Journal ArticleDOI
An algorithm for the operational assessment of adverse drug reactions. II. Demonstration of reproducibility and validity.
Tom A. Hutchinson,John M. Leventhal,Michael S. Kramer,Fred E. Karch,Arthur G. Lipman,Alvan R. Feinstein +5 more
TL;DR: The ADR algorithm appears to provide a reproducible and valid method of evaluating the likelihood of ADRs in individual patients and its use can help improve the diagnostic and epidemiologic approach to these important, complex clinical phenomena.
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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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.
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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