GE Healthcare, a part of General Electric, makes Omniscan, a dye that is used in MRIs (magnetic resonance imaging) and MRAs (magnetic resonance angiography). For most people, the dye leaves the body after being used in testing, but for others – particularly those with chronic kidney disease – it has been shown to stay in the body causing nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy (NFD).

What is NSF/NFD?

Nephrogenic systemic fibrosis (NSF) and nephrogenic fibrosing dermopathy (NFD) are conditions that involve hardening of the skin to a degree that the victim’s internal organs can be damaged, they could lose mobility or even die. NSF/NFD was not discovered until 1997; however, estimates of those who have the disease have been reported anywhere from 200 to 400 worldwide. As of yet, there is no known cure for the disease.

Symptoms of NSF/NFD

According to an alert published by the Food and Drug Administration (FDA), the symptoms of NSF/NFD include:

• For the skin: burning or itching, reddened or darkened patches; and/or skin swelling, hardening and/or tightening
• For the eyes: yellow raised spots on the whites of the eyes
• For the bones, joints and muscles: joint stiffness; limited range of motion in the arms, hands, legs, or feet; pain deep in the hip bone or ribs; and/or muscle weakness

The Administration recommends that anyone who thinks they may have NSF/NFD to have a skin biopsy.

FDA issues warning

The FDA recently issued a warning for Omniscan and four other dyes that are used in MRIs and MRAs. Although each is marketed under a different name, the primary ingredient in all of these drugs is gadolinium. The four other dyes being investigated are:

1. Optimark
2. Magnevist
3. Multihance
4. Prohance

The FDA is continuing to investigate these dyes, which continue to be marketed, and has issued this warning:

While FDA conducts its investigation, the following recommendations are being provided to health care providers and patients:

• Gadolinium-containing contrast agents, especially at high doses, should be used only if clearly necessary in patients with advanced kidney failure
• It may be prudent to institute prompt dialysis in patients with advanced kidney dysfunction who receive a gadolinium contrast MRI/MRA.

If you think you may have developed NSF/NFD, contact an attorney immediately who can review your case. To contact an attorney, click here.