Monitoring of adverse reactions on medicines in children in the Russian federation

Objective of the research - to study safety of medicinal preparations (MP) for children by analyzing a Roszdravnadzor national database of spontaneous reports (SR). This study includes a retrospective analysis of 467 primary SR on severe adverse reactions (AR) in children recorded to database in 2015. Children of preschool age have higher risk of medical therapy complications. Most frequently, skin and whole body (38,7% and 21,1%, respectively) were involved in the pathological process. Unexpected AR were identified in children in 10,8% of cases. They were often caused by antimicrobial system action drugs (43,8%) and drugs for nervous system treatment (26,1%). SR method allows to obtain new information about MP safety in the pediatric population, and to develop measures to reduce risks of medical therapy. © 2017, Pediatria Ltd. All rights reserved.