Nephrogenic Systemic Fibrosis (NSF)
Nephrogenic Systemic Fibrosis (NSF) is a rare and serious disease that involves fibrosis of joints, eyes, skin and internal organs. The cause of Nephrogenic Systemic Fibrosis (NSF) is not fully understood by the medical community, but it definitely appears to be associated with exposure to gadolinium which is used as a contrast dye substance for MRIs and MRAs. Gadolinium is a silvery white, malleable and ductile rare earth metal with a metallic luster used as a component of MRI contrast agents to help enhance images in medical magnetic resonance imaging (MRI).
Patients with Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) may develop large areas or patches of hardened skin or thickened skin with fibrotic nodules and plaques. These areas of thick skin and flexion contractures can severly limit a patient's range of motion. Nephrogenic Systemic Fibrosis (NSF) resembles scleromyxedema at the histologic (microscopic) level; it shows a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers, and deposits of mucin. (Also see Nephrogenic Systemic Fibrosis (NSF) Symptoms for more information.
According to past medical research of patients with Nephrogenic Systemic Fibrosis (NSF), most have undergone hemodialysis for renal failure, some have never undergone dialysis and others have received only peritoneal dialysis. Many Nephrogenic Systemic Fibrosis (NSF) patients have taken immunosuppressive medications and have other diseases, including hepatitis C. To date, four of the five FDA-approved Gadolinium contrast agents are suspected with causing Nephrogenic Systemic Fibrosis (NSF), including Omniscan, Multihance, Magnevist, and OptiMARK. Currently the treatment options for Nephrogenic Systemic Fibrosis (NSF) are somewhat limited to the use of steroids, massage therapies and a few medicines.
NSF and NFD Information
FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images
The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).
The requested warning would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.
"FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "This latest action demonstrates FDA's continuing vigilance about ensuring the safety of drug products once they enter the marketplace."
Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.
FDA first notified health care professionals and the public about the gadolinium-related risks for NSF in June 2006 . Information on the risks was updated in December.
Gadolinium-based contrast agents are commonly used to improve the visibility of internal structures when patients undergo an MRI. Five gadolinium-based contrast agents have been approved for use in the United States:
- Magnevist (gadopentetate dimeglumine)
- Ominiscan (gadodiamide)
- OptiMARK (gadoversetamide)
- MultiHance (gadobenate dimeglumine)
- and Prohance (gadoteridol)
Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. The reports have not always identified a specific agent. Omniscan was the most commonly reported agent, when a specific agent was identified, followed by Magnevist and OptiMARK.
NSF also has developed after the sequential administration of Omniscan and MultiHance and Omniscan and ProHance. Because reports incompletely describe exposure to gadolinium-based contrast agents, it is not possible to know if the extent of risks for developing NSF is the same for all agents.
Patients should be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again.
There have been no reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency.
Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist; GE Healthcare, Chalfont St. Giles, U.K., is the maker of Omniscan; OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.; and ProHance and Multihance are made by Bracco Diagnostics Inc., Princeton, N.J.
News as of May 10, 2008
Side Effects of the MRI Contrast Gadolinium NSF Lawsuits FDA - Public Health Advisory Concerning Gadolinium MRI Contrast Agents FDA Reports NSF Caused by Gadolinium Contrast Agents FDA MRI Report-Gadolinium Nephrogenic Systemic Fibrosis(NSF)Gadolinium Toxicity Lawsuit - Free Case Evaluation
If you or a loved one had a MRI or a MRA, and a contrast dye or agent was used to enhance the MRI image, and you or a loved developed NFS/NFD, kidney failure or renal failure, then you may be eligible to collect money damages for your injuries and damages. Please fill out our Free Case Evaluation Form to better help us assist you, or call us Toll Free at 1-800-883-9858.
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Nephrogenic Systemic Fibrosis (NSF) Nephrogenic Fibrosing Dermopathy (NFD) Causes of NSF Gadolinium MRI What is Gadolinium? Types of Gadolinium Gadolinium FDA Report NSF Symptoms Test for NSF NSF Treatment Doctor Medical Centers NSF Links MRI Lawsuits NSF Lawsuit NSF Punch Biopsy NSF Registry Contact Us
Gadolinium Contrast Dyes:
Omniscan
(Gadodiamide)
Manufacturer: GE Healthcare
OptiMARK
(Gadoversetamide Injection)
Manufacturer: Mallinckrodt
Manufacturer: Tyco Healthcare
Magnevist
(Gadopentetate Dimeglumine)
Manufacturer: Bayer HealthCare
Manufacturer: Schering AG
Manufacturer: Berlex
ProHance
(Gadoteridol Injection)
Manufacturer: Bracco Diagnostics
MultiHance
(Gadobenate Dimeglumine)
Manufacturer: Bracco Diagnostics
NFD and NSF Symptoms:
• Skin Swelling
• Skin Hardening
• Skin Tightening
• Orange Peel Textured Skin
• Reddened Skin
• Darkened Skin Patches
• Burning Skin
• Itchy Skin
• Yellow Raised Spots on Eyes
• Bone Problems
• Joint Problems
• Muscle Problems
• Stiff Joints
• Problems Moving Arms
• Problems Moving Hands
• Problems Moving Legs
• Problems Moving Feet
• Problems Straightening Arms
• Problems Straightening Hands
• Problems Straightening Legs
• Problems Straightening Feet
• Deep Pain in Hip Bones
• Deep Pain in Ribs
• Muscle Weakness
High Risk Patients Have:
• Kidney Problems
• Kidney Insufficiency
• Kidney Failure
• Renal Failure
• Had Liver Transplantation
• Chronic Liver Disease
