title: Drug studies in newborns: a therapeutic imperative.
abstract: Although some drugs have been developed for the neonate, drug development for the least mature and most vulnerable pediatric patients is lacking. Most of the drugs are off-label or off-patent and are empirically administered to newborns once efficacy has been demonstrated in adults and usefulness is suspected or demonstrated in the older pediatric population. Few drugs are approved by the Food and Drug Administration for use in this population. The factors that prevent the demonstration of efficacy and safety in the newborn are discussed and a change in the current approach for neonatal drug studies is suggested.
authors.affiliation: Obstetric and Pediatric Pharmacology Branch; Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6100 Executive Boulevard,Rockville, MD 20852, USA. giacoiag@mail.nih.gov
authors.forename: George P
authors.initials: GP
authors.lastname: Giacoia
authors.forename: Perdita
authors.initials: P
authors.lastname: Taylor-Zapata
authors.forename: Anne
authors.initials: A
authors.lastname: Zajicek
mesh_terms: D002986:Clinical Trials as Topic; D004348:Drug Labeling; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000188:drug therapy*; D019102:Infant, Very Low Birth Weight; D007363:Intensive Care Units, Neonatal; D009359:Neonatology / Q000592:standards*; D056687:Off-Label Use; D061214:Patient Safety; D012107:Research Design