Nephrogenic Systemic Fibrosis (NSF), or Nephrogenic Fibrosing Dermopathy (NFD), was first identified in 1997. The disease occurred in patients with moderate to end-stage renal disease who had MRI or MRAs after being injected with Gadolinium-based contrast dyes to improve MRI imaging. Patients with this condition develop fibrosis of the skin and connective tissues throughout the body. The skin thickening inhibited flexion and extension of joints resulting in contractures. In addition, some patients developed widespread fibrosis of other organs. A skin biopsy is necessary to make a definitive diagnosis. The disease is progressive and may be fatal. Its exact cause is unknown.
Why Use Gadolinium Dye in MRIs and MRAs?
Gadolinium is considered a paramagnetic metal ion, a substance that is known to move into magnetic fields. It is this property that makes Gadolinium so useful in Magnetic Resonance Imaging (MRI) and was approved for this use by the US Food and Drug Administration (FDA) in 1988. The substance is used as a contrast agent, meaning that the substance creates a clearer picture when used in conjunction with an MRI. In some cases, Gadolinium is used with Magnetic Resonance Angiography (MRA), another imaging procedure, even though it has not been approved by the FDA for this use. An MRA is an upgraded type of MRI used to study images of blood vessels. This procedure can detect heart defects, heart disease, and strokes using highly specialized imaging techniques.
An MRI or MRA can be performed without the use of a contrast agent containing Gadolinium, but many believe that MRI images that are taken using a Gadolinium based contrast agent are highly superior to images taken without them. Measures are taken to ensure that the toxicity of the Gadolinium is greatly reduced and under normal circumstances the contrast agent is eliminated from the body by the kidneys in a short period of time. Although it has been reported that the use of a Gadolinium based contrast agent can enhance the images collected from a MRA, the FDA has not yet approved any Gadolinium based contrast agents for this use. The MRA does have the ability to obtain detailed images without the use of any contrast agent. The FDA has approved five MRI contrast agents that contain Gadolinium.
MRI Gadolinium Side Effects
As of December 21, 2006 the FDA has received reports to its Adverse Events Reporting System of 90 patients who developed Nephrogenic Systemic Fibrosis (NSF), or Nephrogenic Fibrosing Dermopathy (NFD), after they received a Gadolinium-based contrast agent for an MRI or MRA; all had moderate to end-stage renal disease and others had kidney failure or renal failure. Patients suffered from severe joint pain, muscle pain, skin rashes, skin irritation, problem with limb mobility, thickening of the skin and other Gadolinium side effects — many have been described in the scientific literature. These patients developed Nephrogenic Systemic Fibrosis (NSF), or Nephrogenic Fibrosing Dermopathy (NFD), two days to 18 months after undergoing their contrast enhanced MRI or MRA. Many of these Nephrogenic Systemic Fibrosis (NSF), or Nephrogenic Fibrosing Dermopathy (NFD), patients received a dose of Gadolinium-based contrast agent exceeding that recommended in product labeling. Some patients developed NSF or NFD after receiving only one dose. Researchers have detected Gadolinium deposits in skin biopsies from patients with NSF or NFD.
Five Types of MRI Gadolinium Dye Contrast Agents
- Magnevist (gadopentetate dimeglumine)
- Omniscan (gadodiamide)
- OptiMARK (gadoversetamide)
- MultiHance (gadobenate dimeglumine)
- Prohance (gadoteridol)
All five Gadolinium MRI contrast dyes: MultiHance, Omniscan, OptiMARK, Magnevist and ProHance have been approved in the U.S. for Magnetic Resonance Imaging (MRI). However, no Gadolinium dye contrast agent is FDA-approved for MRA. The administered dose of Gadolinium-based contrast with Magnetic Resonance Angiography (MRA) is often higher (up to three times) than the approved dose for MRI. Although Nephrogenic Systemic Fibrosis (NSF), or Nephrogenic Fibrosing Dermopathy (NFD), has been reported following administration of three of the five FDA approved Gadolinium-based contrast agents, (Magnevist, Omniscan, and OptiMARK), the FDA believes that there is a potential for NSF or NFD to occur in patients at risk following administration of any of the five approved Gadolinium-based contrast agents.
Worldwide, about 215 cases of Nephrogenic Systemic Fibrosis (NSF), or Nephrogenic Fibrosing Dermopathy (NFD), have been reported to the International Center for NSF/NFD Registry. In 75 of the 215 Nephrogenic Systemic Fibrosis (NSF), or Nephrogenic Fibrosing Dermopathy (NFD), cases reviewed in detail, all had received Gadolinium-based contrast agents for MRAs and MRIs.
MRI Gadolinium Lawsuit - Free Case Evaluation
If you or a loved one had a MRI or a MRA, and a Gadolinium-based contrast dye, medium or agent was used to enhance the MRI image, then your health may be at risk. If you developed Nephrogenic Systemic Fibrosis (NSF), Nephrogenic Fibrosing Dermopathy (NFD), skin problems, skin tightening, severe joint problems, kidney failure, or renal failure, then you may be eligible to collect money damages for your injuries. Please contact us by calling 1-800-883-9858 or follow the link below for a free and confidential case evaluation.
