Safety profile of ultrasmall superparamagnetic iron oxide ferumoxtran-10: Phase II clinical trial data

The safety data from the phase II clinical trial of ferumoxtran-10, an ultr asmall superparamagnetic iron oxide contrast agent, are presented. One hund red and four patients with focal liver or spleen pathologies underwent feru moxtran-10-enhanced magnetic resonance (MR) imaging at doses of 0.8, 1.1, a nd 1.7 mg Fe/kg, Overall, 15% patients reported a total of 33 adverse event s, regardless of causality. The adverse events most frequently seen were dy spnea (3.8%), chest pain (2.9%), and rash (2.9%). No serious adverse events were reported during the 48 hour observation period, There were no clinica lly significant effects on vital signs, physical examination, and laborator y results, Ferumoxtran-10 is a safe and well tolerated MR contrast agent. J . Magn. Reson. Imaging 1999;9:291-294, (C) 1999 Wiley-Liss, Inc.