Document Detail

Incidence of immediate gadolinium contrast media reactions.
MedLine Citation:
PMID:  21257854     Owner:  NLM     Status:  In-Data-Review    
OBJECTIVE: Our objective was to determine the incidence of immediate adverse events for gadolinium-based contrast agents.
MATERIALS AND 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.
CONCLUSION: 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.
Martin R Prince; Honglei Zhang; Zhitong Zou; Ronald B Staron; Paula W Brill
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  AJR. American journal of roentgenology     Volume:  196     ISSN:  1546-3141     ISO Abbreviation:  AJR Am J Roentgenol     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-01-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7708173     Medline TA:  AJR Am J Roentgenol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  W138-43     Citation Subset:  AIM; IM    
Department of Radiology, Cornell and Columbia Universities, 416 East 55th Street, New York, NY 10022.
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