Abstract
Almost all European pharmaceutical companies assess the causal relationship between an adverse event and a drug, but this assessment is generally not included in individual Adverse Drug Reaction (ADR) reports. Most of them do not use any published method but an internal method or no formalized method at all. However, a method is needed for assessing serious or new ADRs. Among European regulatory agencies, France has a particular system since a causality assessment method has been published by the French Ministry of Health and its use is mandatory. In the European Community, a classification in three categories was recently adopted by the member states. We present a new method of drug causality assessment. Due to the lack of a gold standard, methods have been validated mainly through the experts' judgement. Defining and comparing cases and controls, we propose a new model of the validation applied to drug-induced acute hepatic injuries. Most of the criteria have been weighted according to the results of an International Consensus Meeting on drug-induced liver disorders. This method leading to a numerical score seems easy to use, sensitive and specific enough to assess the cases of suspected drug-induced acute hepatic injuries.
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