Guest guest Posted June 6, 2007 Report Share Posted June 6, 2007 http://ilp.legalleadsweb.com/nsf/urn/application/WJ8hNYLAdkeo/ As of December, the FDA had received reports of 90 patients with moderate to end-stage kidney disease who developed NSF/NFD after having an MRI (Magnetic Resonance Imaging) or MRA (Magnetic Resonance Angiography) scan with a gadolinium-based contrast agent. An MRI scan is performed to take a clear detailed picture of a patient's internal organs and tissue and an MRA is used to take a detailed picture of a patient's blood vessels. During some MRI scans and all MRA scans, a gadolinium-based contrast agent is injected into the patient's vein so blood vessels can be distinguished from other nearby tissues. The Food and Drug Administration (FDA) issued a second Public Health Advisory in December 2006 about a new skin disorder known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermotherapy (NSF/NFD). The disease is debilitating and may cause death. In a pivotal study in 2006 conducted by Dr. T. Grobner it was noted that 5 of their 9 patients diagnosed with NSF had received a MRI involving use of Contrast Dye At the current time, NSF/NFD is believed to develop over a period of days to several weeks. • Red or dark patches • Skin may feel " woody " and surface may resemble the texture of the peel of an orange • Contracting and or locking joints • Skin lesions • Yellow papules or plaques on or near the eyes. Patients with NSF/NFD describe swelling and tightening of the skin, usually limited to the extremities, but sometimes involving the trunk. In many cases, the skin thickening inhibits the flexion and extension of joints, resulting in contractures. Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common. Other organs might be affected, including the lungs, liver, muscles, and heart. About 5% of patients have very rapid and progressive disease development, and some patients may die. Nephrogenic systemic fibrosis (NSF) / Nephrogenic Fibrosing Dermopathy (NFD), described in 2000, is an emerging systemic disorder characterized by widespread tissue fibrosis. NFS/NFD was not known to the medical community before March 1997 and some medical authors suggest that the sudden occurrence of the disease in the last 8 years makes it likely that a new agent or technique of examination causes it. Currently, there is no effective treatment available for NSF/NFD. Based on recent research, NSF/NFD occurs only in patients with advanced or in end stage kidney disease and is strongly related to the use of gadolinium dyes for MRI scans. At this time, there are no known cases of NSF/NFD in patients with normal kidney function. Currently, little is known about NSF/NFD. However, due to recent studies, the association is so strong, that both the FDA and the company that makes gadodiamide have sent out warnings about the use of gadolinium-containing contrast in patients with advanced kidney disease. If you, a family member, or friend has suffered NSF/NFD, there is a chance you qualify for monetary compensation from the manufacturer. Don't hesitate to seek justice for the damages you or your loved ones have suffered! Quote Link to comment Share on other sites More sharing options...
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