Safety of ferucarbotran in MR imaging of the liver: a pre- and postexamination questionnaire-based multicenter investigation.
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.
Onishi
Hiromitsu
H
Department of Radiology, Osaka University Graduate School of Medicine, Osaka, Japan.
Murakami
Takamichi
T
Kim
Tonsok
T
Hori
Masatoshi
M
Hirohashi
Shinji
S
Matsuki
Mitsuru
M
Narumi
Yoshifumi
Y
Imai
Yasuharu
Y
Sakurai
Kousuke
K
Nakamura
Hironobu
H
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
D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide