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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TLDR
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
Drug-induced liver injury: a safety review.
TL;DR: Despite the substantial progress made over this century, new approaches using big data analysis to characterize the true incidence of DILI are needed and to categorize the drugs’ hepatotoxic potential.
Journal ArticleDOI
Identification of Specific MicroRNA Biomarkers in Early Stages of Hepatocellular Injury, Cholestasis, and Steatosis in Rats.
TL;DR: The utility of miRNAs as specific biomarkers for the early detection of DILI is suggested, with severalmiRNAs dramatically changed earlier than traditional biomarkers such as alanine aminotransferase (ALT) and aspartate aminOTransferases (AST).
Journal ArticleDOI
Drug induced liver injury: do we still need a routine liver biopsy for diagnosis today?
Rolf Teschke,Christian Frenzel +1 more
TL;DR: To reach at the correct diagnoses of DILI and HILI, clinical and structured causality assessments are better approaches than liver histology results obtained through liver biopsy, an invasive procedure with a low complication rate.
Journal ArticleDOI
Kava hepatotoxicity: comparative study of two structured quantitative methods for causality assessment
TL;DR: This work aimed to compare two different quantitative methods of causality assessment of patients with assumed hepatotoxicity by the herb kava.
Journal ArticleDOI
Allergic cholestatic hepatitis and exanthema induced by metamizole: verification by lymphocyte transformation test.
TL;DR: It is concluded that an allergic cholestatic hepatitis caused by metamizole has induced an allergic reaction not only of the skin but also of the liver in this patient.
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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