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
Carnitine for prevention of antituberculosis drug‐induced hepatotoxicity: A randomized, clinical trial
Shima Hatamkhani,Hossein Khalili,Iman Karimzadeh,Simin Dashti-Khavidaki,Alireza Abdollahi,Sirous Jafari +5 more
TL;DR: In the present study, the potential benefits of oral carnitine in preventing antituberculosis drug‐induced hepatotoxicity (ATDH) were evaluated.
Journal ArticleDOI
A detection algorithm for drug-induced liver injury in medical information databases using the Japanese diagnostic scale and its comparison with the Council for International Organizations of Medical Sciences/the Roussel Uclaf Causality Assessment Method scale
Tadaaki Hanatani,Kimie Sai,Masahiro Tohkin,Katsunori Segawa,Michio Kimura,Katsuhito Hori,Junichi Kawakami,Yoshiro Saito +7 more
TL;DR: The Digestive Disease Week Japan 2004 (DDW‐J) scale was applied to a DILI detection algorithm and compared it with the Council for International Organizations of Medical Sciences/the Roussel Uclaf Causality Assessment Method (CIOMS/RUCAM) scale to confirm its consistency.
Journal ArticleDOI
DILI and drug development: a regulatory perspective.
TL;DR: The development of more effective predictive and analytic tools in preclinical and clinical testing will provide a framework to reliably identify new agents that have hepatotoxic profiles as well as those individuals who are susceptible to develop serious DILI.
Journal ArticleDOI
Fatal case of sorafenib-associated idiosyncratic hepatotoxicity in the adjuvant treatment of a patient with renal cell carcinoma
Benjamin P. Fairfax,S Pratap,Isd Roberts,J Collier,Richard Kaplan,A Meade,A.W.S. Ritchie,Timothy Eisen,Valentine M. Macaulay,Andrew Protheroe +9 more
TL;DR: This is the first reported case of sorafenib exposure associated fatal toxicity in the adjuvant setting and highlights the unpredictable adverse effects of novel adjUvant therapies.
Journal ArticleDOI
Serum metabolome and targeted bile acid profiling reveals potential novel biomarkers for drug-induced liver injury.
TL;DR: Results demonstrate that bile acids could serve as potential biomarkers for the early diagnosis and severity of DILI.
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