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Gadolinium contrast agents, used to enhance MRI films, are extremely dangerous for people with kidney problems. Over the past several years, it has become apparent that gadolinium contrast dyes are causing a rare, but serious disease called nephrogenic systemic fibrosis (NSF), which has only been seen in people with pre-existing kidney disease exposed to these products. NSF leads to excessive formation of connective tissue in the skin and internal organs. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. There are very few effective treatments for NSF, and there is no cure. Symptoms of NSF include: - Unstable or high blood pressure
- Tightening and swelling of the skin, typically starting with the legs, moving to the arms, and sometimes the trunk
- Thickening of the skin around the joints, restricting movement
- Skin which feels "woody" and has a texture similar to that of an orange peel
- Red or dark patches of skin
- Burning, itching, and/or sharp pains in affected areas
- Symmetrical skin lesions, commonly on the ankles and thighs and between the wrists and upper arms
- Muscle weakness
- Deep bone pain in the hips and ribs
Calcification of soft tissues - Yellow plaques near the eyes
There are currently five gadolinium contrast dyes on the market: Omniscan by GE Healthcare; OptiMARK by Mallinckrodt/Tyco Healthcare; Magnevist by Bayer/Schering AG/Berlex; ProHance by Bracco Diagnostics, and MultiHance by Bracco Diagnostics. Gadolinium contrast dyes were approved for use in MRI scans in 1988, and quickly became the preferred contrast agent for use in patients with chronic kidney disease. In 1997, NSF was diagnosed in a patient for the first time. In 2000, the first article to detail the disease was published in the medical journal Lancet. In 2006, a small study by Dutch researchers was the first to find identify a possible connection between gadolinium and NSF. Those scientists reported that of 9 patients with NSF, 5 had undergone an MRI involving a godolinium Contrast Dye. In May of that same year, nephrologists at a St. Louis, Missouri hospital reported a cluster of NSF among patients treated in their dialysis units. The U.S. Centers for Disease Control (CDC) conducted an investigation tand found that the 19 patients eventually included in the study, only five had no identified gadolinium exposure within 1 year preceding NSF diagnosis. However, of these, four had gadolinium exposure from 16 to 68 months preceding diagnosis. Thirteen patients had multiple gadolinium-containing contrast exposures during the preceding year. Then in October 2007, a Scottish researchers published a study involving 1,826 patients who underwent renal replacement therapy at two Glasgow hospitals between January 1, 2000 and July 1, 2006. Of those patients, 421 underwent an MRI that involved the use of a gadolinium based contrast agent. Fourteen were diagnosed with NSF, and of those, 13 had been exposed to gadolinium during an MRI. The researchers also found that the patients with NSF had received far higher doses of gadolinium than those patients who were exposed to gadolinium but did not develop the disorder. In 2007 researchers at Massachusetts General Hospital found that kidney patients who had undergone MRIs with gadolinium contrast dyes were 10 times more likely to develop NSF than patient who had not been exposed to such agents. At the same time, researchers at Yale University reported that 95-percent of those with NSF had an MRI that involved a gadolinium MRI contrast dye two to three months before their symptoms appeared. Around the same time, After the Dutch study was published, the Food & Drug Administration (FDA) issued an alert to healthcare providers that gadolinium based agents had been tied to multiple cases of NSF. At that time, the FDA warned physicians to screen patients for kidney problems prior to using gadolinium based contrast agents during MRIs. In December 2006, the FDA issued its second public health advisory regarding gadolinium based contrast dyes. At that time, the FDA said it had received 90 reports of patients with moderate to end-stage kidney disease who developed NSF after being exposed to gadolinium based contrast agents. Finally in May 2007, the FDA requested that the manufacturers of the five gadolinium based contrast agents used in MRIs include a boxed warning - the FDA's strongest possible safety warning ��" on product labels highlighting the risk they posed to patients with kidney problems. The FDA warned that patients who are at risk for NSF should be monitored by their doctors, and told to report any symptoms associated with the condition immediately. While it is best that people with kidney disease not be exposed to gadolinium contrast dyes, it is not always possible. In these case, the FDA says the contrast agent should be administered at the lowest dose possible. For patients already receiving hemodialysis, the FDA has said that physicians may consider the prompt initiation of hemodialysis following the administration of a gadolinium contrast dye in order to enhance the product's elimination from the body. Very few treatments have proven effective in against NSF. One, photopheresis, has shown some promise, but is often prohibitively expensive. In other cases, kidney transplants have slowed or stopped progression of NSF. However, there is no known cure for NSF.
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Gadolinium, NSF, Kidney Disease,
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