Elsevier

Journal of Hepatology

Volume 11, Issue 2, September 1990, Pages 272-276
Journal of Hepatology

Concensus
Criteria of drug-induced liver disorders: Report of an International Consensus Meeting

https://doi.org/10.1016/0168-8278(90)90124-AGet rights and content

Abstract

International reporting of adverse drug reactions by pharmaceutical manufacturers to national drug regulatory authorities requires internationally accepted standard definitions of reactions and criteria for assessment of causality. The Council for International Organizations of Medical Sciences (CIOMS) undertook a pilot project to prepare such definitions and criteria, and proposed to use as its model a series of expert consensus meetings organized in France by the pharmaceutical company, Roussel Uclaf, with the participation of the official French network of pharmacovigilance. Under CIOMS auspices, an international meeting was organized to test the feasibility of adapting for international use the outcome of the French consensus meetings on drug-induced liver disorders. The meeting resulted in a series of proposed standard designations of drug-induced liver disorders and criteria of causality assessment.

References (12)

  • G Danan

    Consensus meetings on causality assessment of drug-induced liver injury

    J Hepatol

    (1988)
  • C Bénichou et al.

    Réunions de consensus sur les définitions en pharmacovigilance

    Therapie

    (1987)
  • G Danan et al.

    Critères d'imputation d'une hépatite aiguë à un médicament. Résultats de réunions de consensus

    Gastroenterol Clin Biol

    (1987)
  • G Danan

    Diagnosis of drug-induced liver injury (results of consensus meetings)

  • P Solal-Celigny et al.

    Critères d'imputation d'une cytopénie granuleuse ou plaquettaire à un médicament. Résultats de réunions de consensus

    Nouv Rev Fr Hematol

    (1987)
  • B Habibi et al.

    Anémies hémolytiques d'origine médicamenteuse. Résultats de réunions de consensus

    Therapie

    (1988)
There are more references available in the full text version of this article.

Cited by (1069)

View all citing articles on Scopus

This report, prepared by Dr. C. Bénichou of the Division of Pharmacovigilance of Roussel Uclaf, Paris, is the outcome of the work of an international group of experts (listed in Annex 1), which met for 2 days in Paris in June 1989 under the chairmanship of Prof. J.P. Benhamou. The meeting, held under the auspices of the Council for International Organizations of Medical Sciences (CIOMS), was organized by Dr. Bénichou and Dr. G. Danan, also of Roussel Uclaf.

View full text