title: Safety Report of Ferumoxytol for Magnetic Resonance Imaging in Children and Young Adults.
abstract: OBJECTIVE
  The aim of this study was to assess the safety profile of ferumoxytol as an intravenous magnetic resonance imaging contrast agent in children.
  
  
  METHODS
  We prospectively evaluated the safety of ferumoxytol administrations as an "off-label" contrast agent for magnetic resonance imaging in nonrandomized phase 4 clinical trials at 2 centers. From September 2009 to February 2015, 49 pediatric patients (21 female and 28 male, 5-18 years) and 19 young adults (8 female and 11 male, 18-25 years) were reported under an investigator-initiated investigational new drug investigation with institutional review board approval, in health insurance portability and accountability act compliance, and after written informed consent of the child's legal representative or the competent adult patient was obtained. Patients received either a single dose (5 mg Fe/kg) or up to 4 doses of ferumoxytol (0.7-4 mg Fe/kg) intravenously, which were approximately equivalent to one third of the dose for anemia treatment. We monitored vital signs and adverse events directly for up to 1 hour after injection. In addition, we examined weekly vitals, hematologic, renal, and liver serum panels for 1 month after injection in over 20 pediatric patients. At fixed time points before and after ferumoxytol injection, data were evaluated for significant differences by a repeated measures linear mixed model.
  
  
  RESULTS
  Four mild adverse events, thought to be related to ferumoxytol, were observed within 1 hour of 85 ferumoxytol injections: 2 episodes of mild hypotension and 1 case of nausea in 65 injections in pediatric patients without related clinical symptoms. One young adult patient developed warmness and erythema at the injection site. All adverse events were self-resolving. No spontaneous serious adverse events were reported. At a dose of 5 mg Fe/kg or lower, intravenous ferumoxytol injection had no clinical relevance or statistically significant effect (P > 0.05) on vital signs, hematological parameters, kidney function, or liver enzymes within 1 month of the injection.
  
  
  CONCLUSIONS
  Ferumoxytol was overall well tolerated among 49 pediatric and 19 young adult patients experiencing various tumors or kidney transplants without major adverse events or signs of hematologic and kidney impairment or liver toxicity. Larger studies are needed to determine the incidence of anaphylactic reactions.
authors.affiliation: Department of Radiology, Molecular Imaging Program at Stanford (MIPS) and Lucile Packard Children's Hospital, Stanford University, Stanford, CA, USA.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Muehe
authors.affiliation: Department of Radiology, Molecular Imaging Program at Stanford (MIPS) and Lucile Packard Children's Hospital, Stanford University, Stanford, CA, USA.
authors.forename: Dan
authors.initials: D
authors.lastname: Feng
authors.affiliation: Department of Radiation Oncology, Stanford University, Stanford, CA, USA.
authors.forename: Rie
authors.initials: R
authors.lastname: von Eyben
authors.affiliation: Department of Pediatrics, Section of Pediatric Hematology and Oncology, Stanford University, Stanford, CA, USA.
authors.forename: Sandra
authors.initials: S
authors.lastname: Luna-Fineman
authors.affiliation: Department of Pediatrics, Section of Pediatric Hematology and Oncology, Stanford University, Stanford, CA, USA.
authors.forename: Michael P
authors.initials: MP
authors.lastname: Link
authors.affiliation: University of South Carolina School of Medicine, Columbia, SC, USA.
authors.forename: Travis
authors.initials: T
authors.lastname: Muthig
authors.affiliation: Departments of Neurology and Neurosurgery, Oregon Health & Science University, Portland, OR, USA, Portland Veterans Affairs Medical Center, Portland, OR, USA.
authors.forename: Amy E
authors.initials: AE
authors.lastname: Huddleston
authors.affiliation: Departments of Neurology and Neurosurgery, Oregon Health & Science University, Portland, OR, USA, Portland Veterans Affairs Medical Center, Portland, OR, USA.
authors.forename: Edward A
authors.initials: EA
authors.lastname: Neuwelt
authors.affiliation: Department of Radiology, Molecular Imaging Program at Stanford (MIPS) and Lucile Packard Children's Hospital, Stanford University, Stanford, CA, USA.
authors.forename: Heike E
authors.initials: HE
authors.lastname: Daldrup-Link
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000008:administration & dosage*; D005260:Female; D052203:Ferrosoferric Oxide / Q000008:administration & dosage*; D006801:Humans; D008279:Magnetic Resonance Imaging; D061214:Patient Safety; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D003287:Contrast Media; D052203:Ferrosoferric Oxide