Safety and Tolerability of Ultrasmall Superparamagnetic Iron Oxide Contrast Agent
- 1 June 2009
- journal article
- review article
- Published by Wolters Kluwer Health in Investigative Radiology
- Vol. 44 (6), 336-342
- https://doi.org/10.1097/rli.0b013e3181a0068b
Abstract
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. 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). 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. Clinical experience to date therefore shows ferumoxtran-10 to be a well tolerated contrast agent.Keywords
This publication has 36 references indexed in Scilit:
- Magnetic Resonance Imaging of Experimental Inflammatory Bowel DiseaseInvestigative Radiology, 2009
- Hepatocellular Carcinoma in Cirrhotic Liver: Double-Contrast-Enhanced, High-Resolution 3.0T-MR Imaging With Pathologic CorrelationInvestigative Radiology, 2008
- Magnetic Resonance Imaging of Liver Metastases: Experimental Comparison of Anionic and Conventional Superparamagnetic Iron Oxide Particles With a Hepatobiliary Contrast Medium During Dynamic and Uptake PhasesInvestigative Radiology, 2008
- Preclinical Safety and Pharmacokinetic Profile of Ferumoxtran-10, an Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Contrast AgentInvestigative Radiology, 2006
- AMI-227-enhanced MR lymphography: usefulness for differentiating reactive from tumor-bearing lymph nodes.Radiology, 1994
- Ultrasmall superparamagnetic iron oxide: characterization of a new class of contrast agents for MR imaging.Radiology, 1990
- Experimental lymph node metastases: enhanced detection with MR lymphography.Radiology, 1989
- Superparamagnetic iron oxide: pharmacokinetics and toxicityAmerican Journal of Roentgenology, 1989
- Superparamagnetic iron oxide: clinical application as a contrast agent for MR imaging of the liver.Radiology, 1988
- Magnetite albumin microspheres: a new MR contrast materialAmerican Journal of Roentgenology, 1987