Elisangela da Costa Lima1, Guacira Corrêa de Matos2, Jean M de L Vieira3, Ivana C da C R Gonçalves3, Lucio M Cabral2, Mark A Turner4. 1. Universidade Federal do Rio de Janeiro, Faculdade de Farmácia, Observatório de Vigilância e Uso de Medicamentos, Rio de Janeiro, RJ, Brazil. Electronic address: elisangela@pharma.ufrj.br. 2. Universidade Federal do Rio de Janeiro, Faculdade de Farmácia, Observatório de Vigilância e Uso de Medicamentos, Rio de Janeiro, RJ, Brazil. 3. Universidade Federal do Rio de Janeiro, Faculdade de Farmácia, Programa de Pós Graduação em Ciência e Tecnologia Farmacêutica, Rio de Janeiro, RJ, Brazil. 4. University of Liverpool, Institute of Translational Medicine, Department of Women's & Children's Health, Liverpool, United Kingdom.
Abstract
OBJECTIVE: To assess spontaneous reports of suspected adverse drug reactions in children aged 0-12 years from the Brazilian Health Regulatory Agency between 2008 and 2013. METHODS: A cross-sectional study on suspected adverse drug reactions reports related to medicines and health products in children was carried out for a six-year period (2008-2013). Year of report, origin of report by Brazilian state, gender, age, suspected drug, adverse reaction description and seriousness were included in the analysis. The data obtained was compared to the number of pediatric beds in health services and to global data from the VigiBase (World Health Organization). RESULTS: A total of 3330 adverse drug reactions were reported in children in Brazil in the investigated period (54% were in boys). About 28% of suspected adverse drug reactions reports involved 0 to 1-year-old children. Almost 40% of reports came from the Southeast region. Approximately 60% were classified as serious events. There was death in 75 cases. Nearly 30% of deaths involved off-label use; 3875 medicines (465 active substances) were considered suspected drugs. Anti-infective (vancomycin, ceftriaxone, oxacillin, and amphotericin), nervous system (metamizole) and alimentary tract and metabolism medicines were more frequent in reports. CONCLUSIONS: The distribution of suspected adverse drug reactions reports by sex and age group corresponded to the profile of children hospitalized in Brazil. Data about seriousness and medicines reported may be useful to encourage regulatory actions and improve the safe use of medicines in children.
OBJECTIVE: To assess spontaneous reports of suspected adverse drug reactions in children aged 0-12 years from the Brazilian Health Regulatory Agency between 2008 and 2013. METHODS: A cross-sectional study on suspected adverse drug reactions reports related to medicines and health products in children was carried out for a six-year period (2008-2013). Year of report, origin of report by Brazilian state, gender, age, suspected drug, adverse reaction description and seriousness were included in the analysis. The data obtained was compared to the number of pediatric beds in health services and to global data from the VigiBase (World Health Organization). RESULTS: A total of 3330 adverse drug reactions were reported in children in Brazil in the investigated period (54% were in boys). About 28% of suspected adverse drug reactions reports involved 0 to 1-year-old children. Almost 40% of reports came from the Southeast region. Approximately 60% were classified as serious events. There was death in 75 cases. Nearly 30% of deaths involved off-label use; 3875 medicines (465 active substances) were considered suspected drugs. Anti-infective (vancomycin, ceftriaxone, oxacillin, and amphotericin), nervous system (metamizole) and alimentary tract and metabolism medicines were more frequent in reports. CONCLUSIONS: The distribution of suspected adverse drug reactions reports by sex and age group corresponded to the profile of children hospitalized in Brazil. Data about seriousness and medicines reported may be useful to encourage regulatory actions and improve the safe use of medicines in children.
Keywords:
Adverse reactions; Children; Crianças; Database study reporting; Drug monitoring; Farmacoepidemiologia; Monitoramento de medicamentos; Pediatria; Pediatrics; Pharmacoepidemiology; Reações adversas; Relato de estudo de banco de dados
Authors: Elisangela da Costa Lima; Thais de Barros Fernandes; Adair Freitas; Juliana Freire de Lima Sias; Marcelo Gerardin Poirot Land; Mariana Tschoepke Aires; Louise Bracken; Matthew Peak Journal: BMC Med Res Methodol Date: 2021-07-08 Impact factor: 4.615