Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI.

ABSTRACT: Background Ferumoxytol is approved for use in the treatment of iron deficiency anemia, but it can serve as an alternative to gadolinium-based contrast agents. On the basis of postmarketing surveillance data, the Food and Drug Administration issued a black box warning regarding the risks of rare but serious acute hypersensitivity reactions during fast high-dose injection (510 mg iron in 17 seconds) for therapeutic use. Whereas single-center safety data for diagnostic use have been positive, multicenter data are lacking. Purpose To report multicenter safety data for off-label diagnostic ferumoxytol use. Materials and Methods The multicenter ferumoxytol MRI registry was established as an open-label nonrandomized surveillance databank without industry involvement. Each center monitored all fer

SUBMITTER: Nguyen KL 

PROVIDER: S-EPMC6884068 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature