title: Adverse drug reactions in newborns, infants and toddlers: pediatric pharmacovigilance between present and future.
abstract: BACKGROUND
  The detection, assessment, understanding and prevention of adverse drug reactions (ADRs) are the primary aims of pharmacovigilance activities. Pediatric patients, especially all newborns and infants, are particularly at risk for experiencing drug-related adverse events.
  
  
  METHODS
  This review briefly analyzes the physiological peculiarities of pharmacodynamic and pharmacokinetic aspects of drugs in newborns, infants and toddlers and children. It also deals with specific pediatric pharmacovigilance aspects, such as the frequent use of unlicensed and/or off-label drugs in neonatal intensive care units in European countries and in Australia. This review reports on European, American and Canadian data about the incidence and type of pediatric ADRs, particularly focusing on neonates, infants and toddlers.
  
  
  CONCLUSIONS
  The awareness of pediatricians about the importance of reporting ADRs should be stimulated, new reporting systems should be encouraged and pediatric pharmacovigilance activities should be improved, first, by intensifying active post-marketing surveillance methods.
authors.affiliation: Luigi Sacco Hospital, Department of Pediatrics, Università degli Studi di Milano, Via GB Grassi, 74, 20157, Milan, Italy. fabiano.valentina@hsacco.it
authors.forename: Valentina
authors.initials: V
authors.lastname: Fabiano
authors.forename: Chiara
authors.initials: C
authors.lastname: Mameli
authors.forename: Gian Vincenzo
authors.initials: GV
authors.lastname: Zuccotti
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000367:Age Factors; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D056687:Off-Label Use; D004364:Pharmaceutical Preparations / Q000008:administration & dosage; D060735:Pharmacovigilance
chemical_list: D004364:Pharmaceutical Preparations