Free Confidential Case Evaluation (866) 879-3040
Injury Help Network

US Food And Drug Administration Issues Warning About Nephrogenic Systemic Fibrosis

A newly discovered condition was found in 1997 affecting individuals with impaired kidney function and renal failure. The condition was named Nephrogenic Systemic Fibrosis and researchers immediately began to research the cause and the development of the condition. It was found that each of the patients that had been positively diagnosed with Nephrogenic Systemic Fibrosis had recently received an injection of a solution containing Gadolinium prior to an MRI imaging procedure.

Currently, all five of the MRI imaging contrast agents that are approved for use in the United States by the US Food and Drug Administration contain Gadolinium and three of the contrast agents have been positively linked to a patient that has developed Nephrogenic Systemic Fibrosis. All of the patients affected were experiencing impaired kidney function, prompting the US Food and Drug Administration to issue a warning to healthcare professionals about the risks of giving a patient with impaired kidney function an injection of a solution containing Gadolinium. Because little is known about the condition and there is no known cure or treatment method to reverse the effects of the condition, it may be better to prevent the condition from occurring at all than take the risk of whether or not a patient will develop the condition after receiving the injection.

When the first cases of Nephrogenic Systemic Fibrosis were discovered, researchers were perplexed at why only people with impaired kidney function appeared to be susceptible to the condition. As biological agents and ingested medications were being slowly and methodically ruled out, researchers learned about the association between Gadolinium and the development of Nephrogenic Systemic Fibrosis. Because Gadolinium is removed from the body by the kidneys after the injection of the contrast solution, it has been surmised that the kidneys of the patients affected were unable to remove the Gadolinium from the body which allowed the Gadolinium to flow freely throughout the body where it was able to damage skin, muscle, and organ cells in various areas of the body.

A positive diagnosis of Nephrogenic Systemic Fibrosis is obtained by a visible inspection of the skin of the patient and a biopsy of the affected tissue beneath the affected areas of skin. These biopsies have shown the presence of Gadolinium ions in the affected cells, lending weight to the argument that individuals with impaired kidney function are unable to remove the Gadolinium from the body which is causing the development of Nephrogenic Systemic Fibrosis. This causes the skin of the patient to turn fibrous and restrict movement while the muscles beneath the skin begin to calcify and harden, eventually rendering the patient totally immobile or restricted to a wheelchair or bed.

Because the condition is so debilitating and can prove to be fatal to the patients affected by Nephrogenic Systemic Fibrosis, the US Food and Drug Administration and the American College of Radiology have released warnings to doctors and healthcare workers in the country about the complications associated with giving a patient with impaired kidney function an injection of a solution containing Gadolinium. In order to prevent the condition from occurring with more frequency, it is advised that a doctor avoid giving a patient an injection of one of these contrast agents if they suspect that the patient has impaired kidney function and if a injection of the solution is given, then the patient should undergo dialysis immediately to remove the Gadolinium from their system.

DO I HAVE A LAWSUIT?

If you or somebody you know has recently undergone an MRI or MRA procedure that used a Gadolinium-Based Contrast Agent, you should contact us immediately. You have rights and may be entitled to compensation for your Nephrogenic Systemic Fibrosis injuries. 

Please use the form below to contact an Injury Help Network attorney / lawyer directly for a free confidential case review. You may also call toll free 24 hrs/day by dialing (866) 879-3040.

  • Free Confidential Case Evaluation

  • If you or someone you know has been injured, we can help. No matter what type of case you have, you may contact us directly through the contact form below or by calling toll free 24 hrs/day (866) 879-3040.

    Secure 128-bit SSL Encrypted Email CommunicationSecure 128-bit SSL Encrypted Email Communication
    Click Here

Tags: