Anaphylaxis associated with gadolinium-based contrast agents: data from the Food and Drug Administration's Adverse Event Reporting System and review of case reports in the literature.
OBJECTIVE
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.
Univeristy of New Mexico, College of Pharmacy , University of New Mexico, MSC 09 5360, Albuquerque, NM 87131 , USA draisch@salud.unm.edu.
Dennis W
DW
Raisch
Vishvas
V
Garg
Rasha
R
Arabyat
Xian
X
Shen
Beatrice J
BJ
Edwards
Frank H
FH
Miller
June M
JM
McKoy
Beatrice
B
Nardone
Dennis P
DP
West
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000707:Anaphylaxis / Q000139:chemically induced*; D001499:Bayes Theorem; D003287:Contrast Media / Q000009:adverse effects*; D005260:Female; D005682:Gadolinium / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration
D003287:Contrast Media; D005682:Gadolinium