Suspected adverse drug reactions reported for Brazilian children: cross-sectional study

Jornal de pediatria
Elisangela da Costa LimaMark A Turner

Abstract

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. 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). 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...Continue Reading

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Citations

Aug 28, 2020·Frontiers in Pharmacology·Jean Mendes de Lucena VieiraElisangela da Costa Lima
Mar 4, 2021·International Journal of Clinical Pharmacy·Sheila Feitosa RamosDivaldo Pereira de Lyra

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