PROFILE OF ADVERSE EVENTS RELATED TO THE TREATMENT OF CHILDREN WITH TEA: IMPLICAÇÕES FOR PHARMACOVIGILÂNCIA

Abstract

Descrever the profile of AE notifications involving medications that are only used in the treatment of children with ASD. Foram avaliados las EAs associated with the off-label use of psychotropic drugs, using data from the ANVISA – VigiMed notification system. Foram analyzed 520 reported notifications, including 1,608 suspected AEs to medications by System Órgão Classe, two quais highlighting the psychiatric disorders with a greater quantitative of reported AEs, as well as the severity of the reactions per medication, the quais involving notifications of deaths, loss of life, hospitalization or its prolongation and other clinically significant effects. An analysis of two data, taking into consideration the Brazilian region, shows an unequal distribution of notifications between the regions, with emphasis on the Southeast. It was also possible to observe that the largest number of notifications of AEs related to psychotropic drugs used by children in Brazil, by type of entry, was carried out by pharmaceutical companies (61.53%). A slight predominance of the male sex was observed (47.88%), which may be associated, among other factors, with the greater prevalence of TEA in this population. Given the two facts discussed, it is evident the importance of pharmacovigilance in the monitoring of AEs related to medications due to the risks inherent in the off-label use of psychotropic drugs in pediatrics, as well as the relevance that the registration of AEs is possible in the guarantee of patient safety.