What is Nephrogenic Systemic Fibrosis?

Nephrogenic Systemic Fibrosis (NSF) is a rare disease that involves fibrosis of skin, joints, eyes, and internal organs that is associated with exposure to gadolinium used as a contrast dye in a MRI and MRA. In Nephrogenic Systemic Fibrosis (NSF), patients develop large areas of hardened skin with fibrotic nodules and plaques, with an accompanying limitation of range of motion can also occur. Nephrogenic Systemic Fibrosis (NSF) can resemble scleromyxedema.

Nephrogenic Systemic Fibrosis is Discovered

Nephrogenic Systemic Fibrosis was first described in the medical literature in 2000. The first case of Nephrogenic Systemic Fibrosiswas identified in 1997. The cause of Nephrogenic Systemic Fibrosis is unknown but it has been reported only in patients who have severe kidney disease. Nephrogenic Systemic Fibrosis 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. Nephrogenic Systemic Fibrosis 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.

There is no known treatment for Nephrogenic Systemic Fibrosis, however with improved renal function (spontaneous or via renal transplantation),  Nephrogenic Systemic Fibrosis appears to slow or arrest Nephrogenic Systemic Fibrosis and may even result in a gradual reversal of Nephrogenic Systemic Fibrosis  Other treatments are being tested. 

Nephrogenic Systemic Fibrosis from Gadolinium

Nephrogenic Systemic Fibrosis has been reported following administration of all five FDA approved gadolinium-based contrast agents (Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance).  However, some adverse event reports of Nephrogenic Systemic Fibrosis do not include complete information on patients' GBCA exposure history.  Also, some reports indicate that some patients received more than one GBCA prior to Nephrogenic Systemic Fibrosis diagnosis.  The lack of complete information of GBCA exposure, exposure to multiple GBCAs, along with similarities in structure and activity of all these contrast agents, make it impossible at present to definitively determine whether the extent of risks for developing Nephrogenic Systemic Fibrosis is shared by all GBCAs or vary for some of them.  Therefore, FDA considers that Nephrogenic Systemic Fibrosis may occur following the administration of any of the approved GBCAs to certain patients. 

Does gadolinium-based contrast agents cause Nephrogenic Systemic Fibrosis?

Whether the GBCAs are the only agents or conditions that may be associated with Nephrogenic Systemic Fibrosis in patients with renal disease is unknown.  The conclusions that can be drawn from the NSF Nephrogenic Systemic Fibrosis reports are limited.  However, the reports FDA has received, the published report of gadolinium deposits in the skin of patients with Nephrogenic Systemic Fibrosis, and other published reports suggest that GBCAs play a role in the development of NSF in patients with acute or chronic severe kidney insufficiency or kidney dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period.

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