Gadolinium is a contrast agent that helps distinguish between normal and abnormal tissue in the body when used with magnetic resonance imaging (MRI) and CT Scans. The FDA issued a second Public health Advisory about a new skin disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermotherapy (NSF/NFD). Nephrogenic Systemic Fibrosis may occur in patients with moderate to end-stage kidney disease after they have had a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) scan with a gadolinium based contrast agent. The disease is debilitating and may cause death. The FDA has been investigating the link between Gadolinium and NSF/NFD with increased MRI side effects since June 2006.

Nephrogenic Systemic Fibrosis (NSF)

Nephrogenic Systemic Fibrosis was originally thought to be a skin condition, leading to thickening of the skin on joints, making movement difficult. However, NSF has been shown to affect the internal organs, including the abdominal muscles, diaphragm, and lungs – causing serious side effects and possibly leading to death.

The effects of Nephrogenic Systemic Fibrosis are very dangerous. NSF/NFD is characterized by areas of tight and rigid skin that makes it difficult to bend joints. It may also result in fibrosis or scarring of body organs resulting in the inability of body organs to work properly. The Stenger Law Firm, LLC recommends anyone who has recently undergone and MRI or has MRI side effects to watch for any of the following NSF/NFD symptoms:

  • Skin hardening or tightening
  • Darkening patches of skin
  • Burning or Itching Sensations
  • Stiff joints or difficulty in movement
  • Pain in ribs or hip area
  • Muscle weakness
  • Kidney/renal problems

MRI Side Effects

As of December 2006, the FDA had received reports of 90 patients with moderate to end-stage kidney disease who developed NSF/NFD after having an MRI with a Gadolinium-based contrast agent. MRI side effects can develop after an MRI scan is performed to take a detailed picture of a patients internal organs and tissue. An MRA is used to take a detailed picture of a patients blood vessels. During some MRI scans and all MRA scans, a Gadolinium-based contrast agent is injected into the patients vein so blood vessels can be distinguished from other nearby tissues.

Five Gadolinium-based contrast agents are approved by the FDA for use during an MRI. The trade names for these products are:

  • Omniscan
  • OptiMARK
  • Magnevist
  • ProHance
  • MultiHance

None of these agents are approved by the FDA for MRA. The dose of Gadolinium-based contrast agent given to patients undergoing an MRA is often higher (up to 3 times) than the approved dose for an MRI.

In the 90 reports received by the FDA, some of the patients who developed NSF/NFD had been given a high dose of the contrast agent while others had received the recommended amount. In these patients, the Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) began from 2 days to 18 months after exposure to the contrast agent.

If you or a loved one has been diagnosed with Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) after being injected with an MRI contrast agent that contained Gadolinium, the NSF Attorneys at the Stenger Law Firm, LLC can help you explore your legal options. For a Free Case Review call toll free (888) 665-0077.

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