title: Safety of sildenafil in infants*.
abstract: OBJECTIVE
  In view of the recent U.S. Food and Drug Administration's warning against the use of sildenafil in pediatric patients, we aimed to provide an updated overview of the dosing and safety of sildenafil in infants and to explore the relevance of the present safety concerns to the infant population.
  
  
  METHODS
  The National Library of Medicine PubMed and Cochrane Database of Systematic Reviews were searched using the following terms: Sildenafil AND (infant OR infants OR newborn OR newborns OR child OR children OR childhood OR pediatric OR pediatrics OR paediatric OR paediatrics).
  
  
  METHODS
  Studies presenting original clinical data regarding the dosing, use, or safety of sildenafil in infants with pulmonary hypertension would be included.
  
  
  METHODS
  Of the 49 included studies, case reports and case series were the most common type of publications (n = 25). The identified trials included 625 children, with more than 140 infants. Persistent pulmonary hypertension of the newborn and pulmonary hypertension associated with other conditions were the most common underlying diagnoses.
  
  
  CONCLUSIONS
  There is currently no evidence of serious adverse event in infants exposed to sildenafil. Present safety concerns regarding the use of sildenafil in pediatric patients should be further explored before being applied to infant population. Sildenafil remains a valuable option for the treatment of pulmonary hypertension in young infants. Prospective studies should be designed in such a way that they include a safety assessment to evaluate potential adverse outcomes of sildenafil therapy in this population.
authors.affiliation: 1Division of Pediatric Clinical Pharmacology, Children's National Medical Center, George Washington University School of Medicine and Health Sciences, Washington, DC. 2Duke Clinical Research Institute, Durham, NC. 3Department of Pediatrics, Duke University, Durham, NC. 4Department of Pediatrics, Children's National Medical Center, George Washington University School of Medicine and Health Sciences, Washington, DC. 5Department of Pharmacology and Physiology, Children's National Medical Center, George Washington University School of Medicine and Health Sciences, Washington, DC. 6Intensive Care, Erasmus Medical Center-Sophia Children's Hospital, Rotterdam, The Netherlands. 7Department of Paediatric Pharmacology, University Children's Hospital Basel, Switzerland.
authors.forename: Samira
authors.initials: S
authors.lastname: Samiee-Zafarghandy
authors.forename: P Brian
authors.initials: PB
authors.lastname: Smith
authors.forename: Johannes N
authors.initials: JN
authors.lastname: van den Anker
mesh_terms: D001778:Blood Coagulation Disorders / Q000139:chemically induced; D002318:Cardiovascular Diseases / Q000139:chemically induced; D005128:Eye Diseases / Q000139:chemically induced; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000401:mortality; D007223:Infant; D007231:Infant, Newborn; D009420:Nervous System / Q000187:drug effects; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects*; D011687:Purines / Q000008:administration & dosage / Q000009:adverse effects; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000008:administration & dosage* / Q000009:adverse effects*
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate