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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, +1 more
- 01 Nov 1993 - 
- Vol. 46, Iss: 11, pp 1323-1330
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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.
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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.

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Citations
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Journal ArticleDOI

Drug-Induced Liver Injury Network Causality Assessment: Criteria and Experience in the United States

TL;DR: This review will discuss the DILIN expert opinion process, its strengths and weaknesses, psychometric performance and future.
Journal ArticleDOI

Drug induced liver injury: accuracy of diagnosis in published reports.

TL;DR: Alternative diagnoses are common in primarily suspected DILI cases and should be excluded early in future cases, requiring a thorough clinical and causality assessment.
Journal ArticleDOI

Acute liver failure induced by idiosyncratic reaction to drugs: Challenges in diagnosis and therapy

TL;DR: DILI that reaches the threshold of ALF will more often than not require transplantation, since survival without transplant is around 25%.
Journal ArticleDOI

Herbal hepatotoxicity: a hidden epidemic

TL;DR: The problem of the lacks of standardization of herbal drugs, the lack of randomized clinical trials regarding the majority of these products, the unawareness of risks by the patients who buy and use them, and the problem of underreporting are discussed.
References
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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.

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

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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