title: [Adverse drug reactions in pediatrics: Experience of a regional pharmacovigilance center].
abstract: OBJECTIVE
  To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics.
  
  
  METHODS
  An observational study on all ADR notifications recorded in the French pharmacovigilance database by the Regional Pharmacovigilance Center of Champagne-Ardenne between 1 January 1985 and 31 December 2014 involving children from 0 to 17 years inclusive was performed. For all notifications, we studied the patient and the ADR characteristics.
  
  
  RESULTS
  During the study period, 632 notifications were collected. The most frequently reported ATC (anatomical, therapeutic and chemical) classes were vaccines (15.9%), antineoplastics (12%) and antibiotics (11.1%). Forty-six percent of the notifications were serious. For serious ADRs, the most involved drugs were paracetamol, asparaginase and ibuprofen. Skin reactions were the most often reported ADRs. The most common lowest level terms (LLT) were urticaria (4.9%), hypersensitivity (4.1%), fever (2.9%) and vomiting (2.8%).
  
  
  CONCLUSIONS
  ADR reporting to the pharmacovigilance system, in particular pediatric ADRs, should be encouraged. Information on the use of medicinal products, especially on self-medication use, need to be improve.
authors.affiliation: Centre régional de pharmacovigilance et de pharmaco-épidémiologie de Champagne-Ardenne, CHU de Reims, 51092 Reims, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Saint-Martin
authors.affiliation: Unité d'aide méthodologique, pôle recherche et innovations, CHU de Reims, 51092 Reims, France; EA 3797, faculté de médecine, université de Reims Champagne-Ardenne, 51100 Reims, France.
authors.forename: Lukshe
authors.initials: L
authors.lastname: Kanagaratnam
authors.affiliation: Centre régional de pharmacovigilance et de pharmaco-épidémiologie de Champagne-Ardenne, CHU de Reims, 51092 Reims, France; EA 3797, faculté de médecine, université de Reims Champagne-Ardenne, 51100 Reims, France.
authors.forename: Paul
authors.initials: P
authors.lastname: de Boissieu
authors.affiliation: Centre régional de pharmacovigilance et de pharmaco-épidémiologie de Champagne-Ardenne, CHU de Reims, 51092 Reims, France.
authors.forename: Brahim
authors.initials: B
authors.lastname: Azzouz
authors.affiliation: Centre régional de pharmacovigilance et de pharmaco-épidémiologie de Champagne-Ardenne, CHU de Reims, 51092 Reims, France; EA 3797, faculté de médecine, université de Reims Champagne-Ardenne, 51100 Reims, France.
authors.forename: Malak
authors.initials: M
authors.lastname: Abou Taam
authors.affiliation: Centre régional de pharmacovigilance et de pharmaco-épidémiologie de Champagne-Ardenne, CHU de Reims, 51092 Reims, France; EA 3797, faculté de médecine, université de Reims Champagne-Ardenne, 51100 Reims, France. Electronic address: ttrenque@chu-reims.fr.
authors.forename: Thierry
authors.initials: T
authors.lastname: Trenque
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D060735:Pharmacovigilance
keywords: Adverse drug reactions; Effets indésirables médicamenteux; Pediatry; Pharmacovigilance; Pédiatrie