[Importance and specificity of pharmacovigilance in the pediatric population]
Frédérique Rodieux1, Kuntheavy Ing-Lorenzini1, Victoria Rollason1
1Centre d'information thérapeutique, Centre régional de pharmacovigilance, Service de pharmacologie et toxicologie cliniques, Département APSI, HUG, 1211 Genève 14.
Abstract:
Clinical trials are usually conducted in a limited time and on a selected population, most often excluding children. These clinical trials provide a first safety profile of the drugs, undeniably essential but often partial, highlighting only the most common adverse drug reactions. In addition in pediatrics, due to growth and physiologic maturation, adverse drug reactions may differ between children and adults and extrapolation of data obtained in adults to children, including safety data, may be inaccurate. Pharmacovigilance, which is based on spontaneous notifications of adverse drug reactions, helps to refine the risk/benefit ratio of drugs and to increase their safety after market launch. This article aims to highlight the importance of pharmacovigilance in general and in particular in the pediatric population and to remind the modalities of reporting in Switzerland.
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