[Comparative risks and benefits of drugs. Methodological problems].
A focalizing toxicity is defined here as a specific toxicity which attracts much of the attention devoted to the safety of a drug: the hematotoxicity of "second generation" antidepressants is a typical example of such toxicity. The way in which it is handled is frequently biased, whether this be related to its perception or its reporting; as a result, it hampers the process of assessing the risk/benefit ratio of drugs. An attempt is made here to sketch the principles and methods of the validation of safety data; antidepressants furnish various examples of the different points that we make. Finally, we insist upon the fact that assessment of drug risk/benefit ratio must be global and comparative.
Biscos-Garreau
M
M
Groupe de Recherche en Pharmacovigilance, Neauphle-le-Château.
Girard
M
M
D000818:Animals; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000633:toxicity; D004341:Drug Evaluation; D004353:Drug Evaluation, Preclinical; D006801:Humans
D000928:Antidepressive Agents
Risques et bénéfices comparés des médicaments. Problèmes méthodologiques.