What Does the Boxed Warning Tell Us? Safe Practice of Using Ferumoxytol as an MRI Contrast Agent.

BACKGROUND AND PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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]; P = .007). CONCLUSIONS: 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.

[Alexia without agraphia: a clinico-tomographic study]. / Alexia sem agrafia: estudo clínico-tomográfico.

The authors report the clinical findings and CT-scanning results in two cases of alexia without agraphia and review the literature on this subject. Both patients had extensive infarction in the territory supplied by the left posterior cerebral artery and developed severe alexia without agraphia, right hemianopia without color-anomia and one of them presented with transient verbal memory difficulties. In both cases the evolution was very good, with total regression of the alexia after 17 months in the first patient and almost complete recovery after there months in the second one. The authors comment on the causes and possible mechanisms of the alexias, especially of the alexia without agraphia, and suggest that every patient with right hemianopic disturbances due to occlusion of the left posterior cerebral artery be thoroughly studied from a neurological point of view, so that this syndrome can be detected since, notwithstanding its recognized rarity, it seems highly probable that many cases have been overlooked as a result of incomplete examination of the patients.