Incidence of immediate gadolinium contrast media reactions.
OBJECTIVE
Our objective was to determine the incidence of immediate adverse events for gadolinium-based contrast agents.


METHODS
All gadolinium-based contrast agent adverse events reported to radiology quality assurance committees were graded according to American College of Radiology criteria and divided by the total number of injections to determine incidence during the past 10 years. For each event, an age- and examination-matched control patient was identified to compare sex, weight, creatinine, eosinophil count, allergic history and gadolinium-based contrast agent dose differences. The U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) database was analyzed to compare local experience to national trends.


RESULTS
Abdominal MRI had the highest rates of adverse events, 0.013% compared with brain (0.0045%, p < 0.001) or spine (0.0034%, p < 0.001). Adverse events were more likely in women, with a female to male ratio of 3.3, and in patients with history of prior allergic reactions (p < 0.001). Immediate adverse events rates were 0.2, 0.5, 1.2, and 3.3 per 1,000 injections for gadodiamide, gadopentetate dimeglumine, gadobenate dimeglumine, and gadoteridol, respectively. Gadobenate dimeglumine had more severe patient reactions, including three patients who arrested (defined as the patient becoming unresponsive and the code team being called), one of whom died. From 2004 to 2009, the FDA received reports on 40 gadolinium-based contrast agent U.S. deaths unrelated to nephrogenic systemic fibrosis, with an incidence per million doses of 0.15, 0.19, 0.97, 2.7, and 0.7 for gadodiamide, gadoversetimide, gadopentetate dimeglumine, gadobenate dimeglumine, and gadoteridol, respectively.


CONCLUSIONS
This limited retrospective analysis shows that gadolinium-based contrast agents are very safe, with only rare reports of death, and raises the possibility that nonionic linear gadolinium-based contrast agents and gadopentetate dimeglumine may have fewer severe immediate adverse events compared with gadobenate dimeglumine.
Department of Radiology, Cornell and Columbia Universities, 416 East 55th Street, New York, NY 10022, USA.
Martin R
MR
Prince
Honglei
H
Zhang
Zhitong
Z
Zou
Ronald B
RB
Staron
Paula W
PW
Brill
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000707:Anaphylaxis / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology*; D002423:Cause of Death; D002648:Child; D002675:Child, Preschool; D003287:Contrast Media / Q000009:adverse effects*; D004342:Drug Hypersensitivity / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D005682:Gadolinium / Q000009:adverse effects*; D019786:Gadolinium DTPA / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D007223:Infant; D008279:Magnetic Resonance Imaging; D008297:Male; D008536:Meglumine / Q000009:adverse effects / Q000031:analogs & derivatives; D008875:Middle Aged; D054989:Nephrogenic Fibrosing Dermopathy / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology; D009942:Organometallic Compounds / Q000009:adverse effects; D012189:Retrospective Studies; D014481:United States / Q000453:epidemiology; D055815:Young Adult
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D005682:Gadolinium; D019786:Gadolinium DTPA