A multicenter, randomized, double‐blind study to evaluate the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in patients with liver pathology: Results of a phase III clinical trial

Phase I Clinical Evaluation of Citrate-coated Monocrystalline Very Small Superparamagnetic Iron Oxide Particles as a New Contrast Medium for Magnetic Resonance Imaging

“…This is an adverse event frequently observed in studies evaluating the tolerability of MR contrast media, for instance, other SPIO particles or gadolinium-based chelates. 23,24 However, none of our subjects reported lumbar pain, which is a common adverse event of dextran-coated SPIO or USPIO preparations. 7,23 In one study, 9 of 114 patients had lumbar pain of severe intensity.…”

A Summary of Safety of Gadofosveset (MS-325) at 0.03 mmol/kg Body Weight Dose

“…Incidents of vasodilation, moderate rash, moderate urticaria, and parasthesia also were reported in a study of OptiMARK (99 patients studied) and Magnevist (94 patients studied), with no AEs classed as anaphylactic reaction in the 193 patients receiving either drug. 17 A review of 21,000 patients receiving gadolinium in clinical practice revealed that anaphylactoid reactions occurred at a rate of 0.01% 18 ; however, the rareness of these occurrences and the differences in scrutiny of patients in clinical trials versus data generated from clinical practice makes statistical comparison difficult with our result of one patient in 767 (0.1%).…”

“…The safety of gadoversetamide and gadopentate were compared in a crossover study, showing total AE rates ranging from 37.4% to 47.9%. 17 In clinical trials of gadobenate dimeglumine 18% of patients reported at least one adverse event. 31 The safety profile of gadofosveset is similar safety profile as reported in clinical trials of other available gadolinium contrast agents.…”

MR contrast agents: Physical and pharmacologic basics

“…Numerous studies have been performed comparing ProHance, Omniscan, and OptiMARK to Magnevist, and no significant differences have been found in the incidence of adverse reactions (10,13,(15)(16)(17)(18)(19). For example, the incidence of hives has been reported as ranging from 0.2% to Ͻ2%, these figures being statistically indistinguishable.…”