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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Journal ArticleDOI
Acute Hepatic Injury Associated with Varenicline in a Patient with Underlying Liver Disease
Andrew J. Franck,Lisa R Sliter +1 more
TL;DR: While the benefits of smoking cessation are likely greater than the risk of hepatic injury, clinicians should be cognizant of this reaction associated with varenicline.
Journal ArticleDOI
Alfuzosin-induced acute liver injury.
Seok Yeon Kim,Byung Ho Kim,Seok Ho Dong,Hyo Jong Kim,Young Woon Chang,Rin Chang,Yoon Wha Kim +6 more
TL;DR: A 56-year-old man who developed an acute liver injury after taking alfuzosin for 1 month to control his newly diagnosed benign prostatic hypertrophy is described, whose liver test results had returned to normal five months later after the complete discontinuation of the drug.
Journal ArticleDOI
Fulminant hepatic failure associated with dicoumarol therapy.
TL;DR: The case of a 73-year-old woman who developed a fatal liver disease of a mixed hepatocellular-cholestatic type after 3 months of treatment with dicoumarol is reported.
Journal ArticleDOI
Topical administration of chloramphenicol can induce acute hepatitis
TL;DR: A 37 year old male engineer treated for conjunctivitis with 0.5% chloramphenicol eye drops complained of lethargy, pruritus, dark urine, and icteric sclera seven days after completing the treatment.
Book ChapterDOI
Immune-Mediated Drug-Induced Liver Injury
TL;DR: It is evident that the development of idiosyncratic DILI is a multistep process involving both metabolic and immunologic factors.
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