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The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).
an an MRI and MRA be performed without gadolinium-containing contrast?
MRI can be performed without contrast. However, gadolinium-containing contrast agents provide better diagnostic information in many instances as compared to MRI without contrast.
The use of a gadolinium-containing contrast agent to enhance MRA is not FDA approved. MRA is able to provide detailed images of blood vessels without gadolinium-containing contrast. The use of gadolinium-containing contrast agents has been reported to enhance MRA.
4. Are there other approved MRI contrast agents that do not contain gadolinium?
There are no other approved MRI contrast agents. Imaging contrast agents, such as iodinated contrast agents are used in Computed Tomography, plain X-ray and X-ray angiography. However, these iodinated contrast agents require X-ray imaging rather than MRI.
5. What is the concern regarding gadolinium-containing contrast agents?
The information in the May 29, 2006, press release from the Danish Medicines Agency (DMA) and the January 2006 report by Grobner et al in Nephrology, Dialysis and Transplantation describe patients with renal failure who developed a rare, potentially life-threatening condition called Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD). The DMA was concerned because all patients received a gadolinium enhanced MRA procedure a few weeks to a few months before developing NSF/NSD.
NSF/NFD was first described in the medical literature in 2000. The first case of NSF/NFD was seen in 1997. The disease is seen in patients that have noticeably advanced renal failure. The disease causes fibrosis of the skin and connective tissues throughout the body. Patients develop skin thickening that may prevent bending and extending joints, resulting in decreased mobility of joints. In addition, patients may experience fibrosis that has spread to other parts of the body such as the diaphragm, muscles in the thigh and lower abdomen, and the interior areas of lung vessels. The clinical course of NSF/NFD is progressive and may be fatal.
The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.
Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well.
If you have had an MRI or MRA with gadolinium and believe you may be suffering from NSF, fill out the form below for a free case evaluation.
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