Assessment of rates of acute adverse reactions to gadobenate dimeglumine: review of more than 130,000 administrations in 7.5 years.

OBJECTIVE: The purpose of this study was to determine the incidence of adverse events associated with gadobenate dimeglumine over 7.5 years in a major hospital system consisting of both academic and community hospitals. SUBJECTS AND METHODS: As part of a regular and continuous prospective quality assurance project, MRI technologists contemporaneously recorded all gadolinium-based contrast administrations and any associated adverse reactions, including type of reaction and treatment rendered, between August 1, 2005, and March 14, 2013. Weekly data review was performed by the director of MRI services, who evaluated data both by individual site and by comparison among the participating hospitals and sites within the hospital system. Comparison between reaction rates at different sites was performed with a chi-square test.
RESULTS: Over 7.5 years, 132,252 doses of gadobenate dimeglumine were administered, and 236 reactions were recorded (0.18% of contrast-enhanced examinations). Of these, 133 (56.4% of all adverse reactions) required treatment and 12 (5.1%) qualified as serious. Reaction rates were significantly different between academic (0.23%) and community (0.07%) hospitals (p<0.001). Reaction rates were higher in the initial years of the study, tapering to a lower baseline rate, which was maintained over more than 5 years. The findings were consistent with the Weber and Lalli effects reported in the literature on other pharmaceutical agents.
CONCLUSION: Rates of adverse reactions to gadobenate dimeglumine recorded over 7.5 years were comparable to those reported for other gadolinium-based contrast agents examined over smaller time ranges and populations. The findings reinforce the relatively robust safety profile of this agent.