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September 04, 2008

New MRI Contrast Agent Could be Alternative to Gadolinium

In the wake of a number of injuries occurring after the use of gadolinium contrast agents before an MRI, the U.S. Food and Drug Administration has approved a Fast Track Designation for a new type of contrast agent, ferumoxytol. Gadolinium contrast agents have been strongly linked to the debilitating and sometimes deadly disease Nephrogenic Systemic Fibrosis. Those who have suffered from this disease have previous renal failure in their kidneys. The gadolinium contrast agent is unable to evacuate from the body of an impaired renal system as quickly as those without. The FDA reserves the Fast Track Designation for products intended in the treatment of serious or adverse conditions or have the potential for use in previously unmet needs. This designation helps to accelerate the process of development and review of these products. The quicker approval process of ferumoxytol is driven by the potential that this newer diagnostic agent will be a safe alternative for individuals with chronic kidney disease.

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