title: Safety of ferucarbotran in MR imaging of the liver: a pre- and postexamination questionnaire-based multicenter investigation.
abstract: OBJECTIVE
  To prospectively investigate, by means of a pre-and postexamination questionnaire, the types and frequency of adverse reactions to ferucarbotran (Resovist), a superparamagnetic iron oxide (SPIO) contrast agent.
  
  
  METHODS
  This study was approved by the ethics committee of each of the institutions involved, and all patients gave written informed consent. One questionnaire asking about baseline symptoms before the injection of ferucarbotran, and one about adverse events over a period of seven days after injection were given to 315 patients who underwent ferucarbotran-enhanced magnetic resonance imaging (MRI) of the liver at several institutions. The data for baseline symptoms were used for reference to exclude false-positive adverse reactions and were also compared with the adverse event data to determine with McNemar's chi-squared test the incidence of each symptom.
  
  
  RESULTS
  Before MR examination, 249 clinical symptoms were reported by 102 of 315 patients (32.4%). After the injection of ferucarbotran, 169 adverse events were observed in 78 patients (24.8%). Eventually, 70 adverse events occurring in 45 patients (14.3%) were judged to be adverse reactions to ferucarbotran, defined as possibly or definitely ferucarbotran-related events. All reactions were of mild intensity.
  
  
  CONCLUSIONS
  Ferucarbotran can be considered safe for clinical use in liver MRI.
authors.affiliation: Department of Radiology, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Onishi
authors.forename: Takamichi
authors.initials: T
authors.lastname: Murakami
authors.forename: Tonsok
authors.initials: T
authors.lastname: Kim
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Hori
authors.forename: Shinji
authors.initials: S
authors.lastname: Hirohashi
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Matsuki
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Narumi
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Imai
authors.forename: Kousuke
authors.initials: K
authors.lastname: Sakurai
authors.forename: Hironobu
authors.initials: H
authors.lastname: Nakamura
mesh_terms: D000368:Aged; D003911:Dextrans; D004244:Dizziness / Q000139:chemically induced* / Q000175:diagnosis; D052203:Ferrosoferric Oxide; D006801:Humans; D007501:Iron / Q000008:administration & dosage* / Q000009:adverse effects*; D007564:Japan; D008099:Liver / Q000187:drug effects* / Q000473:pathology*; D008107:Liver Diseases / Q000175:diagnosis*; D058185:Magnetite Nanoparticles; D009325:Nausea / Q000139:chemically induced* / Q000175:diagnosis; D010087:Oxides / Q000008:administration & dosage* / Q000009:adverse effects*; D018570:Risk Assessment; D011795:Surveys and Questionnaires; D014839:Vomiting / Q000139:chemically induced* / Q000175:diagnosis
chemical_list: D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide