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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.
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.

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Citations
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Journal ArticleDOI

Drug-induced liver injury associated with complementary and alternative medicine: a review of adverse event reports in an Asian community from 2009 to 2014

TL;DR: H hepatotoxicity cases associated with CAM in Singapore based on spontaneous adverse event reporting to the Health Sciences Authority (HSA) are analyzed to highlight safety signals for specific herbal ingredients and to facilitate future analyses and the understanding of risk-benefit profiles of CAM.
Book ChapterDOI

Drug-Induced Liver Injury: Introduction and Overview

TL;DR: Over the three editions of this book, the field has seen the field shift from a focus on drug metabolism to cellular pathways of injury to the innate immune/inflammatory system to the current and future focus on the adaptive immune system.
Journal ArticleDOI

Hospital Admissions for Drug-Induced Liver Injury: Clinical Features, Therapy, and Outcomes

TL;DR: It is concluded that step-down steroid therapy for DILI improved curative effect, shortened disease course, and was safe.
Journal ArticleDOI

The mystery of the Hawaii liver disease cluster in summer 2013: A pragmatic and clinical approach to solve the problem.

TL;DR: The Hawaii liver disease cluster is now best explained by various liver diseases rather than any DS, including OEP, as the updated CIOMS scale confirmed the lack of evidence for any DS including O EP as culprit for the cluster.
Journal ArticleDOI

Black cohosh hepatotoxicity: quantitative causality evaluation in nine suspected cases.

TL;DR: The present study shows little, if any, hepatotoxic risks by the use of BC in the analyzed cases, and a lack of significant circumstantial evidence.
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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