Varallyay C G, Toth G B, Fu R, Netto J P, Firkins J, Ambady P, Neuwelt E A
From the Departments of Radiology (C.G.V., J.P.N.).
Neurology (C.G.V., G.B.T., J.P.N., J.F., P.A., E.A.N.).
AJNR Am J Neuroradiol. 2017 Jul;38(7):1297-1302. doi: 10.3174/ajnr.A5188. Epub 2017 May 11.
Despite the label change and the FDA's boxed warning added to the Feraheme (ferumoxytol) label in March 2015, radiologists have shown increasing interest in using ferumoxytol as an MR imaging contrast agent as a supplement or alternative to gadolinium. The goals of this study were to provide information regarding ferumoxytol safety as an imaging agent in a single center and to assess how the Feraheme label change may affect this potential, currently off-label indication.
This retrospective study evaluated the overall frequency of ferumoxytol-related adverse events when used for CNS MR imaging. Patients with various CNS pathologies were enrolled in institutional review board-approved imaging studies. Ferumoxytol was administered as multiple rapid bolus injections. The risk of adverse events was correlated with demographic data/medical history.
The safety of 671 ferumoxytol-enhanced MR studies in 331 patients was analyzed. No anaphylactic, life-threatening, or fatal (grade 4 or 5) adverse events were recorded. The overall proportion of ferumoxytol-related grade 1-3 adverse events was 10.6% (8.6% occurring within 48 hours), including hypertension (2.38%), nausea (1.64%), diarrhea (1.04%), and headache (1.04%). History of 1 or 2 allergies was associated with an increased risk of adverse events (14.61% versus 7.51% [no history]; = .007).
The frequency of mild ferumoxytol-related adverse events was comparable with literature results, and no serious adverse event was recorded. Although the recommendations in the boxed warning should be followed, serious adverse events appear to be rare, and with proper precautions, ferumoxytol may be a valuable MR imaging agent.
尽管2015年3月Feraheme（ ferumoxytol）的药品标签发生变更，且美国食品药品监督管理局（FDA）在其标签上添加了黑框警告，但放射科医生对使用ferumoxytol作为磁共振成像（MR）造影剂来补充钆剂或作为钆剂的替代品表现出越来越浓厚的兴趣。本研究的目的是提供关于ferumoxytol作为单一中心成像剂安全性的信息，并评估Feraheme标签变更可能如何影响这一目前未获批准的潜在适应证。
这项回顾性研究评估了ferumoxytol用于中枢神经系统MR成像时相关不良事件的总体发生率。患有各种中枢神经系统疾病的患者被纳入经机构审查委员会批准的成像研究。Ferumoxytol通过多次快速推注给药。不良事件的风险与人口统计学数据/病史相关。
分析了331例患者中671次ferumoxytol增强MR研究的安全性。未记录到过敏、危及生命或致命（4级或5级）的不良事件。ferumoxytol相关的1-3级不良事件的总体比例为10.6%（8.6%发生在48小时内），包括高血压（2.38%）、恶心（1.64%）、腹泻（1.04%）和头痛（1.04%）。有1次或2次过敏史与不良事件风险增加相关（14.61%对7.51%[无过敏史]；P = 0.007）。
与ferumoxytol相关的轻度不良事件的发生率与文献结果相当，且未记录到严重不良事件。尽管应遵循黑框警告中的建议，但严重不良事件似乎很少见，并且采取适当的预防措施后，ferumoxytol可能是一种有价值的MR成像剂。
