title: Adverse drug reactions in children: a ten-year review of reporting to the Portuguese Pharmacovigilance System.
abstract: OBJECTIVE
  Adverse drug reactions (ADR) are a public health problem. They cause significant morbidity, mortality and health costs. Less is known about pediatric ADR. Our goal was to characterize a pediatric case series of ADR reported to the Portuguese Pharmacovigilance System (PPS) during the past 10 years.
  
  
  METHODS
  Retrospective analysis of ADR reports concerning patients till 17 years old received by the PPS between 2003 and 2012. We evaluated patients' demographic data and involved drugs, as well as characteristics and seriousness of reactions, stratified by age groups.
  
  
  RESULTS
  We found 1742 reports (50% females) corresponding to 9.7% of the total received. The age of the patients varied from 0 to 17 years (median: 5 years, interquartile range: 10.6), with 566 cases (32%) occurring in patients younger than 2y. Among the 1195 serious cases, 31% (370) episodes led to hospitalization. In 32 cases (2%) there was a fatal outcome. Most of the ADR reported referred to general disorders and administration site conditions, followed by skin and subcutaneous tissue reactions. Vaccines were the most represented group (42%) followed by antibacterials for systemic use (17%).
  
  
  CONCLUSIONS
  Pediatric ADR represents about 10% of the reports received by the PPS. Most ADR were considered serious. Major findings varied according to age groups.
authors.affiliation: a Direção de Gestão do Risco de Medicamentos, Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde , I.P. , Lisboa, Portugal.
authors.forename: Leonor
authors.initials: L
authors.lastname: Nogueira Guerra
authors.affiliation: b Institute for Research in Biomedicine - iBiMED & Health Sciences Department, Aveiro, Portugal CESPU, Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde , Gandra , Portugal.
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Herdeiro
authors.affiliation: c Faculdade de Medicina da Universidade do Porto, Unidade de Farmacovigilância do Norte , Porto , Portugal.
authors.forename: Inês
authors.initials: I
authors.lastname: Ribeiro-Vaz
authors.affiliation: d Instituto do Emprego e Formação Profissional (IEFP) , Setúbal , Portugal.
authors.forename: Maria Inês Pinto
authors.initials: MI
authors.lastname: Clérigo
authors.affiliation: e Department of Quality in Health, Directorate-General of Health , Lisboa , Portugal.
authors.forename: Cristina
authors.initials: C
authors.lastname: Rocha
authors.affiliation: f Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde , I.P. , Lisboa , Portugal.
authors.forename: Ana
authors.initials: A
authors.lastname: Araújo
authors.affiliation: a Direção de Gestão do Risco de Medicamentos, Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde , I.P. , Lisboa, Portugal.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Pêgo
authors.affiliation: g Allergy Department, Centro Hospitalar do Porto EPE , Porto , Portugal.
authors.forename: Eva
authors.initials: E
authors.lastname: Rebelo Gomes
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D017677:Age Distribution; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D060735:Pharmacovigilance; D011174:Portugal / Q000453:epidemiology; D012189:Retrospective Studies
keywords: adverse drug reactions; pediatric; pharmacovigilance