Questionnaire survey of acute and delayed adverse reactions to ferumoxides.
OBJECTIVE
The purpose of this study was to assess acute and delayed adverse reactions to ferumoxides.


METHODS
473 consecutive patients who underwent ferumoxides-enhanced MRI were enrolled in this study. Following non-contrast-enhanced MRI, patients were interviewed about their allergic history, and after ferumoxides-enhanced MRI, they were asked to fill out a questionnaire sheet to record any symptoms within one week.


RESULTS
345 of 473 questionnaires (72.9%) were returned. Fifty-eight of 345 patients (16.8%) showed some adverse reactions considered to be related to ferumoxides: 25 (7.2%) during administration, 25 (7.2%) later on the day of ferumoxides administration, and 17 (4.9%) within one week. Thirty-three patients (9.6%) showed only delayed adverse reactions. Delayed adverse reactions were more frequent in women than in men (p<0.01), and in patients with any allergic history than in those without such history (p<0.05). Acute adverse reactions tended to be more frequent in patients who had some adverse events to any contrast medium than in those with no such history (p=0.069).


CONCLUSIONS
By using the questionnaire, the incidence of adverse reactions to ferumoxides (16.8%) was higher than previously reported from Japanese clinical trials.
Kurata
Tadayoshi
T
Department of Diagnostic Radiology, Keio University School of Medicine, Japan.
Tanimoto
Akihiro
A
Shinmoto
Hiroshi
H
Yuasa
Yuji
Y
Kuribayashi
Sachio
S
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media / Q000009:adverse effects*; D003911:Dextrans; D005260:Female; D052203:Ferrosoferric Oxide; D006801:Humans; D007501:Iron / Q000009:adverse effects*; D008279:Magnetic Resonance Imaging; D058185:Magnetite Nanoparticles; D008297:Male; D008875:Middle Aged; D010087:Oxides / Q000009:adverse effects*; D011795:Surveys and Questionnaires
D003287:Contrast Media; D003911:Dextrans; D058185:Magnetite Nanoparticles; D010087:Oxides; D007501:Iron; C065507:ferumoxides; D052203:Ferrosoferric Oxide