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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Montelukast induced acute hepatocellular liver injury.
TL;DR: A 46-year-old male with uncontrolled asthma on inhaled albuterol and formoterol with budesonide was commenced on montelukast and development of abdominal pain and jaundice and liver tests showed an increase in serum total bilirubin and returned to normal 55 days after drug cessation.
Journal ArticleDOI
Role of Ursodeoxycholic Acid in Treating and Preventing Idiosyncratic Drug-Induced Liver Injury. A Systematic Review.
TL;DR: A systematic review of the role of UDCA in the treatment and prevention of DILI was performed in this paper, where the authors reported improvement of liver injury associated with UDCA therapy whereas 7 case reports did not show clinical or biochemical improvement after UDCA treatment.
Journal ArticleDOI
The hepatotoxic potential of protein kinase inhibitors predicted with Random Forest and Artificial Neural Networks.
TL;DR: The structure-activity relationship of PKIs in relation to hepatotoxicity was investigated and the estimated probability of hepatot toxicity was generally high for single PKIs, however, depending on the target kinase of the PKI, a difference in hepatotoxic potential could be observed.
Journal ArticleDOI
Diagnosis of drug-induced liver injury in Japanese patients by criteria of Consensus Meetings in Europe.
Toshikazu Masumoto,Norio Horiike,Masanori Abe,Teru Kumaki,Hiroshi Matsubara,S.M. Fazle Akbar,Kojiro Michitaka,Ichinosuke Hyodo,Morikazu Onji +8 more
TL;DR: Assessment of Japanese patients with drug-induced liver injury indicated that the criteria of Consensus Meetings in Europe were useful for diagnosing drug- induced liver injury in Japanese patients.
Journal ArticleDOI
Causality assessment of liver injury after chronic oral amiodarone intake
Lucía Llanos,Rocío Moreu,Ana M. Peiró,Sonia Pascual,Rubén Francés,José Such,J.F. Horga,Miguel Pérez-Mateo,Pedro Zapater +8 more
TL;DR: A new Bayesian‐developed model is proposed to help in the causality assessment of amiodarone‐induced liver injury, which is infrequent and difficult to predict.
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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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