Devastating Condition Called Nephrogenic Systemic Fibrosis Subject Of Alert By The FDA

Schmidt & Clark, LLP is No Longer Taking These Cases - If you feel that you may have a potential case, we urge you to contact another law firm adequately suited to handle your case.

The US Food and Drug Administration has recently become aware of a number of cases of Nephrogenic Systemic Fibrosis occurring in some individuals with advanced kidney disease and kidney failure. These individuals had recently undergone an MRI or MRA procedure using a Gadolinium based MRI contrast agent to enhance the images obtained the procedure. There are five Gadolinium based MRI contrast agents approved for use in MRI image enhancement by the FDA, but there are no approved contrast agents for MRA procedures. Due to this association, the FDA is recommending that physicians carefully weigh the risk of using a Gadolinium based MRI contrast agent to improve the images of the MRI against the risk of the patient developing this potentially fatal condition.

Patients with advanced kidney disease or kidney failure are warned that they stand the greatest risk of developing Nephrogenic Systemic Fibrosis after exposure to a Nephrogenic Systemic Fibrosis. All of the confirmed cases of the condition have occurring in patients with moderate to severe kidney disease and those undergoing dialysis. Research continues into the association between Gadolinium based MRI contrast agents and the development of Nephrogenic Systemic Fibrosis, with investigators learning more about the condition with every passing day.

The first cases of Nephrogenic Systemic Fibrosis were identified in 1997 and were found to affect patients with acidosis and renal failure exclusively. The condition causes the fibrosis of the skin in patchy areas on the upper and lower extremities. The onset of the condition appears as reddened or darkened patches on the skin that begin to harden and become thick. This causes the patient severe discomfort and limits their ability to move. As Nephrogenic Systemic Fibrosis moves throughout the body, it also causes fibrosis of the soft connective tissue and internal organs of the patients. In some cases, the patient dies of organ failure.

Although the appearance of the condition is quite distinctive, a skin biopsy is needed for a definitive diagnosis. The presence of Gadolinium ions can be found contained in the cells of the inspected tissue, furthering the belief that Gadolinium based MRI contrast agents are the cause of the condition. The signature symptoms of Nephrogenic Systemic Fibrosis are darkened areas appearing on the skin, difficulty extending the joints of the upper and lower extremities, skin swelling and tightening, deep bone pain, and a persistent burning or itching sensation in the affected areas of the skin. Over time, the patient will experience a hardening of the tissue beneath the affected area due to the calcification of the soft tissue. Nephrogenic Systemic Fibrosis is a progressive condition with no known cure and no consistently effective treatment. This makes the avoidance of developing the condition in the first place the best course of action to take.

Awards & recognition