TY - JOUR
T1 - Anaphylaxis associated with gadolinium-based contrast agents
T2 - Data from the Food and Drug Administration's adverse event reporting system and review of case reports in the literature
AU - Raisch, Dennis W.
AU - Garg, Vishvas
AU - Arabyat, Rasha
AU - Shen, Xian
AU - Edwards, Beatrice J.
AU - Miller, Frank H.
AU - McKoy, June M.
AU - Nardone, Beatrice
AU - West, Dennis P.
N1 - Funding Information:
This manuscript was funded by National Institute of Health Grant # 2 R01 CA102713-03A2. The NIH was not involved in any aspect of the study or preparation of the manuscript. There were no conflict of interest among the authors. No additional persons contributed to the research.
PY - 2014/1
Y1 - 2014/1
N2 - Objectives: To summarize reports of anaphylaxis associated with gadolinium-based contrast agents (GBCAs) reported to the Food and Drug Administrations Adverse Event Reporting System (FAERS), examine the safety signals of anaphylaxis from GBCAs, and perform a literature review of relevant case reports. Methods: FAERS (1/1988-8/2012) was searched using groups of preferred event terms for anaphylaxis combined with all drug names for GBCAs Signal detection involved determination of proportional reporting ratios (PRRs) and empirical Bayes geometric means (EBGM). Published case reports were identified through a Medline search (1/1988-7/2013). Results: There were 614 GBCA FAERS reports of anaphylaxis, resulting in a safety signal (PRR = 6.2, 95% confidence interval (CI) = 5.7-6.7; EBGM = 5.1 CI = 5.6-6.6). Among GBCAs, 43% were associated with gadopentetate dimeglumine (PRR = 4.9, CI = 4.3-5.5; EBGM = 4.8, CI = 4.3-5.4), 29% with gadobenate dimeglumine (PRR = 17.5, CI = 15.2-20.2; EBGM = 17.1, CI = 14.6-19.8) , and 17% with gadoteridol (PRR = 5.7, CI = 4.7-6.8; EBGM = 5.6, CI = 4.6-56.7). There were 14 anaphylaxis case reports in the literature. Conclusions: GBCAs used as medical imaging agents, can cause life-Threatening or fatal anaphylaxis. There were differences in disproportionality of reporting between between agents. Although differences in numbers of reports of anaphylaxis reflect relative utilization rates of the various agents, disproportionality analyses (PRR, EBGM) disclose significant safety signals of anaphylaxis associated with most GBCAs.
AB - Objectives: To summarize reports of anaphylaxis associated with gadolinium-based contrast agents (GBCAs) reported to the Food and Drug Administrations Adverse Event Reporting System (FAERS), examine the safety signals of anaphylaxis from GBCAs, and perform a literature review of relevant case reports. Methods: FAERS (1/1988-8/2012) was searched using groups of preferred event terms for anaphylaxis combined with all drug names for GBCAs Signal detection involved determination of proportional reporting ratios (PRRs) and empirical Bayes geometric means (EBGM). Published case reports were identified through a Medline search (1/1988-7/2013). Results: There were 614 GBCA FAERS reports of anaphylaxis, resulting in a safety signal (PRR = 6.2, 95% confidence interval (CI) = 5.7-6.7; EBGM = 5.1 CI = 5.6-6.6). Among GBCAs, 43% were associated with gadopentetate dimeglumine (PRR = 4.9, CI = 4.3-5.5; EBGM = 4.8, CI = 4.3-5.4), 29% with gadobenate dimeglumine (PRR = 17.5, CI = 15.2-20.2; EBGM = 17.1, CI = 14.6-19.8) , and 17% with gadoteridol (PRR = 5.7, CI = 4.7-6.8; EBGM = 5.6, CI = 4.6-56.7). There were 14 anaphylaxis case reports in the literature. Conclusions: GBCAs used as medical imaging agents, can cause life-Threatening or fatal anaphylaxis. There were differences in disproportionality of reporting between between agents. Although differences in numbers of reports of anaphylaxis reflect relative utilization rates of the various agents, disproportionality analyses (PRR, EBGM) disclose significant safety signals of anaphylaxis associated with most GBCAs.
KW - Anaphylaxis
KW - FDA adverse event
KW - Gadolinium-based contrast agents
KW - Reporting system
KW - Serious adverse event
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U2 - 10.1517/14740338.2013.832752
DO - 10.1517/14740338.2013.832752
M3 - Article
C2 - 24053773
AN - SCOPUS:84890515686
SN - 1474-0338
VL - 13
SP - 15
EP - 23
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
IS - 1
ER -