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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An updated method improved the assessment of adverse drug reaction in routine pharmacovigilance.
Hélène Théophile,Manon André,Yannick Arimone,Françoise Haramburu,Ghada Miremont-Salamé,Bernard Bégaud +5 more
TL;DR: The updated logistic causality assessment method presented here improves the initial version that had poor specificity and tended to overestimate drug causation and presents satisfactory characteristics to be used in routine pharmacovigilance.
Journal ArticleDOI
Drug‐induced liver injury with skin reactions: Drugs and host risk factors, clinical phenotypes and prognosis
Harshad Devarbhavi,Sujata Raj +1 more
TL;DR: The characteristics of liver involvement in patients with severe cutaneous adverse reaction are discussed and it is likely that the delayed immune‐mediated reaction triggering skin reaction is also responsible for hepatitis.
Journal ArticleDOI
Fatal Acute Hepatitis After Sequential Treatment With Levofloxacin, Doxycycline, and Naproxen in a Patient Presenting With Acute Mycoplasma pneumoniae Infection
Miguel F Carrascosa,María Isabel Lucena,Raúl J. Andrade,José Ramón Salcines Caviedes,Antonio Cuadrado Lavín,Juan Corral Mones,Andrea P. Rivero,Vicente B. Serrano +7 more
TL;DR: A case of lethal hepatitis possibly/probably associated with levofloxacin, doxy-cycline, and naproxen in a patient with acute M pneumoniae infection is reported.
Journal ArticleDOI
Hepatitis E masquerading as drug‐induced liver injury
Emerson Y. Chen,Karl Baum,William Collins,Arthur Löve,Michael Merz,Sigurdur Olafsson,Einar Bjornsson,William M. Lee +7 more
TL;DR: The patient presented below gives the opportunity to discuss challenges in the diagnosis of drug‐induced liver injury in an era of increasing awareness of hepatitis E.
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Toxicidad hepática recurrente secundaria a metilprednisolona intravenosa
M. Rivero Fernández,José María Riesco,Moreira Vf,A. Moreno,A. López San Román,G. Arranz,L. Ruiz del Árbol +6 more
TL;DR: The case of a middle-aged woman with multiple scle rosis who received a bolus of methylprednisolone on three occasions for the management of relapsing disease, with the development of repeated episodes of elevated liver enzymes after corticoid administration is reported.
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