Document Detail

Safety of ferucarbotran in MR imaging of the liver: a pre- and postexamination questionnaire-based multicenter investigation.
MedLine Citation:
PMID:  19097079     Owner:  NLM     Status:  MEDLINE    
PURPOSE: 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.
MATERIALS AND 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.
CONCLUSION: Ferucarbotran can be considered safe for clinical use in liver MRI.
Hiromitsu Onishi; Takamichi Murakami; Tonsok Kim; Masatoshi Hori; Shinji Hirohashi; Mitsuru Matsuki; Yoshifumi Narumi; Yasuharu Imai; Kousuke Sakurai; Hironobu Nakamura
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Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  Journal of magnetic resonance imaging : JMRI     Volume:  29     ISSN:  1053-1807     ISO Abbreviation:  J Magn Reson Imaging     Publication Date:  2009 Jan 
Date Detail:
Created Date:  2008-12-24     Completed Date:  2009-02-19     Revised Date:  2013-04-11    
Medline Journal Info:
Nlm Unique ID:  9105850     Medline TA:  J Magn Reson Imaging     Country:  United States    
Other Details:
Languages:  eng     Pagination:  106-11     Citation Subset:  IM    
Department of Radiology, Osaka University Graduate School of Medicine, Osaka, Japan.
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MeSH Terms
Dizziness / chemically induced*,  diagnosis
Iron / administration & dosage*,  adverse effects*
Liver / drug effects*,  pathology*
Liver Diseases / diagnosis*
Magnetite Nanoparticles
Nausea / chemically induced*,  diagnosis
Oxides / administration & dosage*,  adverse effects*
Risk Assessment
Vomiting / chemically induced*,  diagnosis
Reg. No./Substance:
0/Magnetite Nanoparticles; 0/Oxides; 1317-61-9/Ferumoxytol; 7439-89-6/Iron; 9004-54-0/Dextrans; G6N3J05W84/ferumoxides

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