CAUSALITY ASSESSMENT OF ADVERSE REACTIONS TO DRUGS .1. A NOVEL METHODBASED ON THE CONCLUSIONS OF INTERNATIONAL CONSENSUS MEETINGS - APPLICATION TO DRUG-INDUCED LIVER INJURIES

Despite the great number of methods proposed, assessing the causal rol e 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 crit eria are usually not adapted to the injured organ, decreasing the spec ificity 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 attrib uted. The method was applied to reports of acute liver injuries. The r eproducibility 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.