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FDA has received reports of nephrogenic systemic fibrosis (NSF) in patients who received gadolinium-based contrast agents. Nephrogenic Systemic Fibrosis was first described in the medical literature in 2000. The first case of Nephrogenic Systemic Fibrosis was identified in 1997.
NSF 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. NSF usually starts in the lower extremities. Fibrosis can also develop in the diaphragm, muscles in the thigh and lower abdomen, and lung vessels. Over time, Nephrogenic Systemic Fibrosis becomes worse and can cause death.
Gadolinium is a paramagnetic metal ion. Paramagnetic ions, such as gadolinium, move differently within a magnetic field. Therefore it has been used in MRI and MRA's. The FDA has requested the manufacturers of all five Gadolinium agents (Magnevist, MultiHance, Omniscan, OptiMARK and ProHance) to add a new boxed warning and a new Warnings section to their labels to describe the risk of developing NSF.
Gadolinium agents are approved by FDA for use with MRI as a contrast agent to provide an improved image. A possible association between NSF and Gadolinium contrast agents was first reported in a May 29, 2006, press release from the Danish Medicines Agency (DMA) and the April 2006 report by Grobner et al in Nephrology. Recent publications have provided additional important information implicating a role for GBCAs in the development of NSF among some patients. Researchers have found gadolinium in the tissue of patients with NSF. Also, a retrospective study with Omniscan in about 370 patients with severe renal insufficiency estimated the risk of NSF to be 4%. A case-control study of the occurrence of nephrogenic fibrosing dermopathy (NFD) indicated that exposure to GBCA was independently associated with NFD. Together, accumulating data indicate that GBCAs increase the risk for the development of NSF among patients with severe renal insufficiency or renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period.
If you have been diagnosed with Nephrogenic Systemic Fibrosis or NFD after having a gadolinium MRI or MRA you should contact an attorney. For a free case evaluation, please fill out the form below:
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