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On May 29, 2006, a press release from the Danish Medicines Agency 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. Gadolinium is a paramagnetic metal ion. Gadolinium-containing contrast agents are manufactured by a chelating process, a procedure in which large organic molecules form a stable complex around the gadolinium. The chelate reduces the chances of toxicity that could result from exposure to free gadolinium. This stable complex is eliminated via the kidneys in patients with normal functioning kidneys.
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.
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.
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.
If you have been diagnosed with NSF or NFD you should contact an attorney immediately. For a free case evaluation, fill out the form provided below:
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