title: Adverse drug reactions in Nigerian children: a retrospective review of reports submitted to the Nigerian Pharmacovigilance Centre from 2005 to 2012.
abstract: BACKGROUND
  Adverse drug reactions (ADRs) in children recorded in national pharmacovigilance databases in high-income countries have been analysed. Nigeria has a population of 31 million children and became a member of the WHO Programme for International Drug Monitoring in 2004 since when it has been submitting reports of suspected ADRs to the WHO Global Individual Case Safety Report database, VigiBase.
  
  
  OBJECTIVE
  To gain information on reported ADRs in Nigerian children aged 0-17 years in VigiBase from 2005 to 2012.
  
  
  METHODS
  The data were analysed for annual reports, age and sex of patients, type of reporters, suspected drugs and adverse reactions. The most commonly reported ADRs and suspected drugs were ranked, and drugs associated with the fatalities were evaluated.
  
  
  RESULTS
  A total of 297 reports of 473 ADRs in 297 children were received from doctors, pharmacists, other health-care professionals and consumers during the period. ADRs were most frequently reported for anti-retrovirals (74, 24%), antibiotics (71, 23%) and anti-malarials (60, 20%). The most frequently reported ADRs were rash (15.2%), fever (10.3%) and pruritus (6.8%). Anti-infective agents were responsible for more than half of the reports. Twenty-one children (7%) died, eight from acute renal failure. Seven of the cases of acute renal failure were associated with contaminated paracetamol/diphenhydramine hydrochloride and herbal medicines used for teething problems. In the majority of cases, the products were contaminated with diethylene glycol. There were 14 cases of Stevens-Johnson syndrome, three of which were fatal.
  
  
  CONCLUSIONS
  Anti-infective agents (antibiotics, anti-malarials and anti-retrovirals) were associated with a majority of the ADRs. Stevens-Johnson syndrome was the most frequent severe ADR. Some of the fatalities were associated with sub-standard and herbal medications.
authors.affiliation: a The University of Nottingham , Academic Division of Child Health, Derbyshire Children's Hospital , UK.
authors.forename: Kennedy
authors.initials: K
authors.lastname: Obebi Cliff-Eribo
authors.affiliation: a The University of Nottingham , Academic Division of Child Health, Derbyshire Children's Hospital , UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Sammons
authors.affiliation: b Uppsala Monitoring Centre , WHO Collaborating Centre for International Drug Monitoring , Uppsala , Sweden.
authors.forename: Kristina
authors.initials: K
authors.lastname: Star
authors.affiliation: b Uppsala Monitoring Centre , WHO Collaborating Centre for International Drug Monitoring , Uppsala , Sweden.
authors.forename: I
authors.initials: I
authors.lastname: Ralph Edwards
authors.affiliation: c National Pharmacovigilance Centre , National Agency for Food and Drug Administration and Control , Abuja , Nigeria.
authors.forename: Adeline
authors.initials: A
authors.lastname: Osakwe
authors.affiliation: a The University of Nottingham , Academic Division of Child Health, Derbyshire Children's Hospital , UK.
authors.forename: Imti
authors.initials: I
authors.lastname: Choonara
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009549:Nigeria / Q000453:epidemiology; D060735:Pharmacovigilance; D012189:Retrospective Studies
keywords: Adverse drug reactions; Children; Drug safety; Paediatrics; Pharmacovigilance; Spontaneous reporting