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G Danan

Publications and source records attributed to G Danan.

At least 19 recordsLinked to original sources
PubMed1993

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.

Despite the great number of methods proposed, assessing the causal role of a drug in the occurrence of an adverse medical event remains one of the most controversial issues. Qualifying terms for criteria, such as "compatible", "suggestive" of "inconclusive", have never been strictly defined, leading to low reproducibility. Weights of the criteria are usually not adapted to the injured organ, decreasing the specificity of the method. In this paper, a new method for drug causality assessment is described. Contents and limits of the criteria have been defined by experts convened to organ-oriented international consensus meetings. Additional criteria have been introduced and weights attributed. The method was applied to reports of acute liver injuries. The reproducibility was tested by an independent team. The validity of this novel method is studied in the following paper, based on an original approach using reports with positive rechallenge as external standard.

Age Factors↗
PubMed1993

Causality assessment of adverse reactions to drugs--II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge.

Standards are lacking for validation of drug causality assessment methods. An original model is proposed using a positive rechallenge as an external standard. This model was used to validate the novel causality assessment method (RUCAM) described in the previous article (Part I; J Clin Epidemiol 1993; 46: 1323). Seventy seven reports of drug-induced acute liver injuries with positive rechallenge were collected from the medical literature and divided into 49 cases and 28 controls. The RUCAM was applied to information obtained prior to readministration. The score was significantly higher (p < 10(-4)) in cases than in controls with high levels of sensitivity, specificity and predictive values. It is concluded that (1) adverse drug reaction reports with a positive rechallenge can provide a standard for validation of causality assessment methods, (2) RUCAM applied to drug-induced liver injuries has been validated.

Age Factors↗
PubMed1989

[Drug-induced renal insufficiency. Results of consensus meetings].

We report the conclusions of consensus meetings organized by the "Direction de la Pharmacovigilance" of Roussel Uclaf, and attended by University Hospital Nephrologists, members of the National Network of Pharmacovigilance and representatives of Roussel Uclaf Drug Monitoring Department, in order to define more accurately, as regards drug-induced renal failure, the criteria and the terminology proposed by the French method of causality assessment of adverse drug reactions.

Humans↗
PubMed1988

Causality assessment of drug-induced liver injury. Hepatology Working Group.

None of the various methods for drug reaction assessment has been adapted to the well-defined damage of a specific organ. There are disagreements between the parties involved in this issue: practitioners, and experts in drug surveillance either in regulatory agencies or in the pharmaceutical industry. Consensus Meetings were therefore organized in order to answer the three basic questions related to the diagnosis of drug-induced liver injury: (a) is the liver involved? (b) what chronological and clinical criteria suggest a drug-induced reaction? (c) can non-drug-related causes be excluded? On the basis of the method for drug reaction assessment used in France, we describe criteria adapted to the case of acute cytolytic hepatitis, which constitutes only one aspect of the task of the Hepatology Working Group.

Chemical and Drug Induced Liver Injury↗
PubMed1987

Prolonged cholestasis after troleandomycin-induced acute hepatitis.

We report the case of a patient in whom troleandomycin-induced hepatitis was followed by prolonged anicteric cholestasis. Jaundice occurred after administration of troleandomycin for 7 days and was associated with hypereosinophilia. Jaundice disappeared within 3 months but was followed by prolonged anicteric cholestasis marked by pruritus and high levels of alkaline phosphatase and gammaglutamyltransferase activities. Finally, pruritus disappeared within 19 months, and liver tests returned to normal 27 months after the onset of hepatitis. This observation demonstrates that prolonged cholestasis can follow troleandomycin-induced acute hepatitis.

Acute Disease↗
PubMed1987

[Criteria for assessing granulocytic or platelet cytopenia caused by drugs. Results of consensus meetings].

The use of an official drug adverse reaction assessment procedure became compulsory in France in 1984. The method proposed various qualifications for the semiologic and chronologic criteria used to ascribe a disorder to a specific drug but did not define them. Consensus meetings have been organized in order to define, in the main pathological fields, the adverse reactions themselves and the various qualifications of the criteria. This paper reports the results of meetings attended by hematologists, members of the French national network of Pharmacovigilance and representatives of Roussel Uclaf Drug Monitoring Department for drug-induced granulocyte and platelet cytopenias. Participants studied (a) the limits of the time interval between the appearance of the adverse reaction and the beginning or the end of the treatment with the suspected drug; (b) interpretation of a possible rechallenge; and (c) diagnostic value of in vitro tests proposed to confirm the responsibility of a specific drug in a granulocytic or platelet cytopenia.

Agranulocytosis↗