MRI contrast agent, gadobenate dimeglumine, safety profile confirmed in 7.5-year trial.
Gadobenate dimeglumine MRI contrast agent has rates of adverse reactions comparable to other gadolinium-based contrast agents, according to a study published in the American Journal of Roentgenology.
Researchers from the University of Pittsburgh Medical Center in Pennsylvania examined the findings of a prospective quality assurance project to determine the incidence of adverse effects with the contrast agent.
During the project, MRI technologists tracked all gadolinium-based contrast administrations at a large tertiary care center and a community hospital with a free-standing cancer treatment center, and any associated adverse reactions, including type of reaction and treatment rendered, between August 1, 2005, and March 14, 2013, a 7.5 year period.
The results showed that 132,252 doses of gadobenate dimeglumine were administered. A total of 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, per FDA criteria.
The researchers found a significant difference between reaction rates at the academic center (0.23%) and the community hospital (0.07%). The reaction rates were higher in the first two years of study, tapering to a lower baseline rate, which was maintained over more than five years, they noted.
The authors concluded that their study confirmed the relatively robust safety profile of gadobenate dimeglumine.