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October 17, 2008

Vanderbilt Study Links NSF to Gadolinium Contrast Dyes

A new study undergone by researchers at Vanderbilt University has again shown a strong link between the use of gadolinium dyes and the disease Nephrogenic Systemic Fibrosis found in patients with renal failure. The team of researchers concluded with the warning that gadolinium contrast dyes should be used “judiciously” in patients with kidney disease opining that the benefits should be carefully weighed against the risks. In the study researchers at Vanderbilt analyzed data from case reports submitted to the U.S. Food and Drug Administration. The study found the occurrence of NSF after gadolinium contrast agent exposure depended on the degree of renal dysfunction, amount of contrast agent administered, gadolinium contrast agent stability and the severity of a patient’s kidney disease. NSF has devastated the lives of hundreds of individuals and their families. NSF is characterized by high blood pressure, burning, itching, swelling and hardening of the skin to the point of immobility. Other symptoms include deep pain in the hips and ribs and muscle weakness. In September 2007 the FDA ordered a “black box” warning, the most severe used, to be added to the labels of the manufacturers products including, Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare and Mallinckrodt. Since then lawsuits have been filed in state and federal courts against the companies for the injuries incurred after the exposure to the gadolinium contrast dyes. As of September 24, there were 287 NSF lawsuits pending in the Multidistrict Litigation. Another 104 lawsuits have been filed in various state courts throughout the U.S.

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