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

Elisangela da Costa Lima1, Guacira Corrêa de Matos1, Jean M de L Vieira2

  • 1Universidade Federal do Rio de Janeiro, Faculdade de Farmácia, Observatório de Vigilância e Uso de Medicamentos, Rio de Janeiro, RJ, Brazil.

Jornal De Pediatria
|July 22, 2018
PubMed

Insights

Adverse drug reactions in Brazilian children (0-12 years) were analyzed from 2008-2013. Serious events and off-label use were noted, highlighting the need for safer medication practices in pediatrics.

Area of Science:

  • Pediatric Pharmacology
  • Pharmacovigilance
  • Public Health

Background:

  • Adverse drug reactions (ADRs) pose a significant risk to pediatric populations.
  • Monitoring ADRs is crucial for ensuring medication safety in children.
  • Understanding ADR patterns in specific regions, like Brazil, is essential for targeted interventions.

Purpose of the Study:

  • To analyze spontaneous reports of suspected adverse drug reactions in children aged 0-12 years in Brazil.
  • To identify trends in ADRs, including demographics, suspected drugs, and outcomes.
  • To provide data that can inform regulatory actions and improve pediatric medication safety.

Main Methods:

  • A cross-sectional study analyzed ADR reports from the Brazilian Health Regulatory Agency (2008-2013).
  • Data included report year, origin, child's gender and age, suspected drug, reaction description, and seriousness.
  • Comparisons were made with pediatric bed data and global VigiBase data.

Main Results:

  • 3330 ADRs were reported in children; 54% were in boys.
  • 28% of reports involved infants (0-1 year); 40% originated from the Southeast region.
  • 60% of ADRs were serious, with 75 deaths; nearly 30% of deaths involved off-label drug use. Anti-infectives and nervous system drugs were frequently implicated.

Conclusions:

  • ADR report distribution by sex and age aligns with hospitalized pediatric populations in Brazil.
  • Findings on ADR seriousness and implicated drugs can guide regulatory actions.
  • The study underscores the importance of improving safe medication use in children.
Abstract

Keywords:
Adverse reactionsChildrenCriançasDatabase study reportingDrug monitoringFarmacoepidemiologiaMonitoramento de medicamentosPediatriaPediatricsPharmacoepidemiologyReações adversasRelato de estudo de banco de dados

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