Assessment of adverse reaction rates to a newly approved MRI contrast agent: review of 23,553 administrations of gadobenate dimeglumine.

OBJECTIVE: With the introduction of a newly approved MR contrast agent across a health care system encompassing 13 hospitals and associated imaging centers, the opportunity arose to compare the rates of adverse reactions in seven of these facilities with reactions reported in the literature. Data were collected to assess the relative risk of using gadobenate dimeglumine compared with published data for other approved agents and for this agent in preclinical testing. SUBJECTS AND METHODS: As part of regular quality assurance procedures, technologists recorded contrast administrations and related adverse reactions, including the type of reaction and treatments rendered, on log sheets. All data were reviewed weekly by the institutional director of MR services and were evaluated globally and by site.
RESULTS: Over 13 months, 23,553 doses of gadobenate dimeglumine were administered. One hundred seventy-eight reactions were recorded (0.76% of contrast-enhanced examinations), of which 22 required treatment (13% of reactions) and eight (5% of reactions) qualified as serious.
CONCLUSION: With the introduction of the most recent MR contrast agent approved for use in the United States, our interest in its substantial potential clinical benefits that would result from its increased relaxivity was balanced by concern that the rate of adverse effects may increase. This concern has been ameliorated with the findings of rates of adverse reactions that are comparable to those published for other MR contrast agents.