Nephrogenic Systemic Fibrosis (NSF)

Patients who receive gadolinium-based dyes during MRI or MRA testing are at risk for developing NSF (Nephrogenic Systemic Fibrosis), a dangerous and potentially fatal disease. Typically, NSF is a disease that starts in the skin of the patient's extremities, arms and legs, and moves to other areas of the body. The patient's skin becomes stiff, causing reduced mobility and significant pain. Over the past several years, researchers have linked the development of NSF (also referred to as NFD or Nephrogenic Fibrosing Dermotherapy) to the use of gadolinium-based contrast agents.

Gadolinium is a chemical element used as a contrast agent in MRI and MRA testing. An MRI (or Magnetic Resonance Imaging) is a test used by physicians to gather visual images of a patient's internal organs and tissue. Similarly, an MRA (or Magnetic Resonance Angiography) is a test used to obtain a picture of an individual's blood vessels. While gadolinium-based dyes are occasionally used in MRA testing, they are very commonly used in MRI testing. The distinction between MRI testing and MRA testing is important because the use of gadolinium-based dyes in MRA testing has not been approved by the FDA. However, the FDA has approved five gadolinium-based dyes for use in MRI testing:

• Magnevist (gadopentetate dimeglumine)
• Ominiscan (gadodiamide)
• OptiMARK (gadoversetamide)
• MultiHance (gadobenate dimeglumine)
• Prohance (gadoteridol)

Although these gadolinium-based contrast agents are beneficial because they allow physicians to collect improved images of the patient's organs and tissues, their use can also be very dangerous, leading to the development of NSF. Researchers of NSF have determined that patients with NSF all have severe kidney or liver problems. Patients with kidney disease have a decreased ability to dispose of waste in the body. Therefore, those patients are likely to develop NSF because the gadolinium chemical remains in their body for a longer period of time than it would in people with normal kidney function. Currently, there is no accepted cure or treatment for NSF. However, some physicians suggest kidney transplantation as an option to improve the condition.

Patients with NSF (Nephrogenic Systemic Fibrosis) develop thickening skin and connective tissue that inhibits their mobility, and may result in broken bones. Patients suffering from NSF may also experience many of the following symptoms:

Skin and Eyes:

• Swelling, hardening and tightening of your skin
• Reddened or darkened patches on the skin
• Burning or itching of your skin
• Yellow raised spots on the whites of your eyes

Bones and Muscles:

• Stiffness in your joints; problems moving or straightening arms, hands, legs, or feet
• Pain deep in your hip bones or ribs
• Muscle weakness

Although the research and study of NSF (Nephrogenic Systemic Fibrosis) is still in the early stages, there have been some studies providing valuable information on the disease. The Archives of Dermatology published a study that showed it was 77 times more likely a patient undergoing hemodialysis would get NSF. The study also indicated it was 69 times more likely a patient with renal transplantation would get NSF. The U.S. Center for Disease Control conducted a study in May of 2006, which linked the diagnosis of NSF to gadolinium-based dyes in 18 out of the 19 patients examined. One year later, a Yale University study indicated that 95% of patients with NSF were exposed to gadolinium-based dyes in their MRI tests.

After releasing two previous warnings, the United States Food and Drug Administration (FDA) issued a statement in May of 2007 requiring manufacturers to place a black box warning on gadolinium-based dyes. The black box warning is the strongest warning the FDA can issue. The warning explains that patients with kidney problems who receive gadolinium-based dyes are at risk for developing NSF. The warning also indicates that patients who have undergone liver transplantation are at risk for developing this potentially fatal disease.

Contact the Law Offices of d'Oliveria & Associates, P.C.

If you or a loved one is suffering from kidney or liver damage and had an MRI/MRA using a gadolinium-based contrast agent, resulting in the diagnosis of NFS/NFD, you may want to speak with an attorney regarding your potential claim.

Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.