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
Reads0
Chats0
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
More filters
Journal ArticleDOI
Caroli's syndrome in two siblings.
Journal ArticleDOI
Hepatitis aguda tóxica secundaria a dosis única de bupropion
Laura Alonso Rodríguez,Ricardo Barcina Pajares,José Fuentes Vigil,Ana Gutiérrez González,Laura Rodríguez Pérez +4 more
TL;DR: Las reacciones adversas a medicamentos son causa de enfermedad hepática con gran frecuencia, y el número de fármacos antidepresivos se multiplica en el mercado constantemente.
Journal ArticleDOI
Safety reporting through a comprehensive and pragmatic pharmcovigilance process for India and emerging markets: an industry perspective.
TL;DR: There is a need to understand and implement a robust PV system, where electronically globalized, evidence based, public health oriented and regulatory compliant PV system is established, to improve transparency in system and ensure enhancement in safety data reporting ensuring premature and trouble-free detection of ADRs.
Journal ArticleDOI
Delayed Liver Function Impairment Secondary to Interferon β-1a Use in Multiple Sclerosis
TL;DR: Regular liver function monitoring in multiple sclerosis patients who receive interferon β is necessary even after the first 6 months of treatment, especially in those patients with concomitant use of other liver-toxic medications.
References
More filters
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.
Related Papers (5)
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