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

Abstract

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.

Keywords::

• anaphylaxis
• gadolinium-based contrast agents
• FDA adverse event
• reporting system
• serious adverse event