The use of gadolinium-based contrast agents prior to magnetic resonance imaging (MRI) is associated with an increased risk of a debilitating—and potentially fatal—disease known as NSF, or nephrogenic systemic fibrosis. In May 2007, the Food and Drug Administration asked the makers of gadolinium-based MRI dyes to include a black box on the label to warn of the risk of NSF in patients with severe kidney problems. The warning also applies to liver transplant/liver disease patients who experience kidney problems.

What Is Nephrogenic Systemic Fibrosis?

Nephrogenic systemic fibrosis is an extremely rare and devastating disease marked by the thickening and hardening of the skin, muscles, and sometimes the internal organs. The disease was only first discovered in 1997 and there is currently no "consistently effective" treatment, according to the FDA.

Since its initial discovery, nephrogenic systemic fibrosis has been diagnosed in numerous patients who had received a gadolinium-based contrast agent. NSF appeared in these patients anywhere from days to months after receiving an MRI dye. Some of these cases of nephrogenic systemic fibrosis resulted in death.

Signs and symptoms of nephrogenic systemic fibrosis that individuals who’ve undergone an MRI with a gadolinium-based contrast agent should look out for include:

  • Skin swelling, tightening, or hardening
  • Burning, itching, darkened, or red spots on the skin
  • Joint stiffness, limited mobility, muscle weakness, and/or bone pain

FDA Approved Gadolinium Agents

The FDA has approved five gadolinium contrast agents for use prior to MRI: ProHance, MultiHance, OptiMARK, Optiscan, and Magnevist. These agents are used to enhance the quality of the MRI image by creating contrast to make the body’s internal structures clearer. However, gadolinium-based dyes are also sometimes used for MRA (magnetic resonance angiography)—and at much higher doses—even though this is not an approved use. These contrast agents can not only lead to nephrogenic systemic fibrosis, but to other gadolinium side effects as well.

Protect Your Legal Rights

Patients undergo MRI testing as a step toward improving their health, not diminishing it. Learning you have a deadly disease that could have been prevented is devastating and you can do something about it. If you or a loved one developed nephrogenic systemic fibrosis after receiving a gadolinium-based agent, you may be able to take legal action against the product’s maker. Let us help you protect your legal rights. Contact a gadolinium attorney today for a complimentary consultation.

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Gadolinium Contrast Agents Required to Include New Warning

The U.S. Food and Drug Administration (FDA) issued a news release Sept. 9, 2010, requiring that contrast agents containing gadolinium carry a new warning on their labels because it can lead to nephrogenic systemic fibrosis (NSF). Read More »

First Gadolinium Lawsuit Filed in U.S. Court

An Ohio woman has filed what is believed to be the first gadolinium lawsuit, claiming that the MRI dye Magnevist-made by Bayer-caused her 24-year-old son's death.
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Gadolinium-Based MRI Dyes Get Black Box Warning

The Food and Drug Administration has asked that a black box warning be added to all gadolinium-based MRI dyes to highlight the risk of nephrogenic systemic fibrosis, or NSF.
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