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Cited by 115Characterization and Applications of Magnetic NanoparticlesAdvanced MRI Techniques and ApplicationsLanthanide and Transition Metal Complexes

Safety and Tolerability of Ultrasmall Superparamagnetic Iron Oxide Contrast Agent: Comprehensive Analysis of a Clinical Development Program

Bernd, Hamm, De Kerviler, Eric, Gaillard, Sophie, Bonnemain, Bruno·2009·Investigative Radiology
DOI 10.1097/rli.0b013e3181a0068b
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Abstract

BACKGROUND: Because of its cellular uptake pattern, ferumoxtran-10 may be potentially useful for the imaging of a variety of diseases (eg, atheroma, multiple sclerosis, stroke, renal graft rejection, glomerulonephritis and brain tumors, in addition to differentiation of metastatic and nonmetastatic lymph nodes). The aim of this article is to present a comprehensive review of the safety and tolerability of ferumoxtran-10 as reported during clinical development of the compound as an ultrasmall superparamagnetic iron oxide contrast agent for use in magnetic resonance imaging. MATERIALS AND METHODS: The safety profile of ferumoxtran-10 was assessed using pooled data from 37 phase I to III clinical studies in 1777 adults (1663 received the contrast agent [1527 patients and 136 healthy volunteers], 75 received placebo, and 39 patients were enrolled but did not receive study medication). RESULTS: At least one adverse event was reported in 23.2% of patients who received ferumoxtran-10. Adverse events were of mild-to-moderate severity in 86.3% of patients in the ferumoxtran-10 group. At least 1 event considered by the investigator to be related to study treatment was reported in 18.2% of patients in the ferumoxtran-10 group. The most commonly reported treatment-related adverse events were back pain, pruritus, headache, and urticaria. A total of 44 patients (2.6%) in the ferumoxtran-10 group reported 76 serious adverse event (SAE). Only 7 SAEs (0.42%) were considered to be treatment-related (anaphylactic shock, chest pain, dyspnea, skin rash, oxygen saturation decreased, and 2 cases of hypotension). There were 12 deaths, only one of which (anaphylactic shock) was considered to be related to ferumoxtran-10 which was administered by bolus injection of undiluted product, a mode of administration that is no longer recommended. Results in high-risk groups of patients including the elderly and those with hepatic, renal or cardiovascular disease seemed to show no cause for special clinical concern in these groups. CONCLUSIONS: Clinical experience to date therefore shows ferumoxtran-10 to be a well tolerated contrast agent.

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  • Studies investigating the toxicity profile of ferumoxytol and ferumoxtran reported less than 1% serious side effects and 10-20% moderate adverse events.

    “Studies investigating the toxicity profile of ferumoxytol and ferumoxtran reported less than 1% of serious side effects (including anaphylatic shock, chest pain, dyspnea and hypotension) and 10-20% of moderate adverse events (such as back pain, headache and urticaria) [135, 136].”

    From Iron oxide nanoparticles: Diagnostic, therapeutic and theranostic applications (2019) · cites this paper as [135]

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Authors
Bernd, H., De Kerviler, E., Gaillard, S., & Bonnemain, B.
Affiliations
Guerbet (France) (FR)
ORCID
Bonnemain, Bruno
Venue
Investigative Radiology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2009-06
Volume
44
Issue
6
Pages
336-342
ISSN
0020-9996 (ISSN-L)
DOI
10.1097/rli.0b013e3181a0068b
OpenAlex
W2046273167
Cited by
115
References
36
Citations by year
2026: 3 · 2024: 7 · 2023: 3 · 2022: 6 · 2021: 4 · 2020: 7 · 2019: 3 · 2018: 12 · 2017: 5 · 2016: 4 · 2015: 10 · 2014: 10 · 2013: 8 · 2012: 13
FWCI
0.95
Type
journal article
Language
en
Open access
closed
Locations
  • Investigative Radiology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Physical Sciences › Engineering › Biomedical Engineering › Characterization and Applications of Magnetic Nanoparticles
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Advanced MRI Techniques and Applications
  • Physical Sciences › Materials Science › Materials Chemistry › Lanthanide and Transition Metal Complexes
Keywords
ferumoxtran-10, ultrasmall superparamagnetic iron oxide, MRI contrast agents, safety, tolerability, adverse events, serious adverse events, anaphylactic shock, back pain, pruritus, urticaria, elderly patients, renal dysfunction, liver dysfunction, cardiovascular disease
MeSH terms
Aged, Contrast Media, Dextrans, Female, Humans, Male, Ferrosoferric Oxide, Magnetite Nanoparticles

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