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
Zur Langzeitbehandlung chronischer Schmerzpatienten mit Flupirtin
TL;DR: The report in this paper of long-term treatment of chronic pain patients from 7 months to 22 years principally confirms its persistent effectiveness and tolerability.
Journal ArticleDOI
An overview on pharmacovigilance: a key for drug safety and monitoring
TL;DR: There's still no methodology universally accepted for casualty assessment of ADRs, and as a result of assessment strategies are not entirely void of individual judgments, integrator reliableness is often low.
Journal ArticleDOI
Safety of co-administration of herbal and conventional medicines on liver and kidney function in stroke patients: A single-center retrospective study
Sang-Hwa Lee,Seo-Young Kim,Seung-Bo Yang,Chul Jin,Seungwon Kwon,Seung-Yeon Cho,Seong-Uk Park,Woo-Sang Jung,Sang-Kwan Moon,Jung-Mi Park,Chang-Nam Ko +10 more
TL;DR: The results suggest that if appropriately prescribed by experts, the co-administration of CMs and HMs is safe and does not adversely affect liver and kidney function in patients with stroke.
Journal ArticleDOI
Incidence of Dimethylacetamide Induced Toxic Liver Injury among Workers in a Synthetic Fiber Manufacturing Company
Yong Seok Jang,Seong Yong Yoon,Seong Yong Jo,Tae Sung Choi,Jay Young Yoo,Kuck Hyun Woo,Bong Goo Ha,Sang Jae Jung,Byung Yeol Chun,Jin Seok Kim +9 more
TL;DR: The incidence rate of toxic liver injury was considerably high during the 1st year after a worker is placed, so it is needed to take careful monitoring of hepatic enzyme level for newly exposed worker.
DissertationDOI
Improving the measurement and detection of serious adversedrug reactions in databases of stored electronic health records
TL;DR: The CPRD algorithm detected similar flucloxacillin effects as the multisource algorithm and (2) previous studies, and associations with risperidone and celecoxib were also detected.
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