title: Systematic review of paediatric studies of adverse drug reactions from pharmacovigilance databases.
abstract: OBJECTIVE
  To perform a systematic review of studies describing paediatric adverse drug reactions (ADRs) conducted from national pharmacovigilance databases.
  
  
  METHODS
  A systematic literature search of studies describing results for paediatric ADRs from national pharmacovigilance databases was performed. PubMed database, Embase and MEDLINE were searched up to March 2015. The descriptive studies included were analysed for country of origin, reporters, and ADR reporting rate, drugs, ADRs and number of fatalities.
  
  
  RESULTS
  20 studies were identified. Doctors were the largest group of reporters in all the studies, and with more consumer reports seen in USA. The studies ranged from 3 - 37 years. The highest ADR reporting rate was 1458 reports per year per million children in Cuba. Antibiotics and vaccines were the most frequently reported drugs, in almost all the studies. The most frequent ADRs were skin and nervous system disorders. The highest proportion of fatalities and serious reports was from North America. Drugs used for treating attention deficit hyperactivity disorders (ADHD) and isotretinoin were the most frequently reported drugs for ADRs in North America.
  
  
  CONCLUSIONS
  There were geographical differences in drugs responsible for ADRs and their seriousness, especially in North America. Very few studies were conducted in Asia and Latin America, none were found from Africa.
authors: a The University of Nottingham, Academic Division of Child Health, Derbyshire Children's Hospital , Derby , UK.
authors: Kennedy Obebi
authors: KO
authors: Cliff-Eribo
authors: a The University of Nottingham, Academic Division of Child Health, Derbyshire Children's Hospital , Derby , UK.
authors: Helen
authors: H
authors: Sammons
authors: a The University of Nottingham, Academic Division of Child Health, Derbyshire Children's Hospital , Derby , UK.
authors: Imti
authors: I
authors: Choonara
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D002648:Child; D016208:Databases, Factual / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D060735:Pharmacovigilance
keywords: Adverse drug reactions; paediatric; pharmacovigilance database; spontaneous reporting system