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Gadolinium Based Contrast Agents have been linked to a serious, life-threatening skin disorder called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).

If you or somebody you know has developed a skin irritation or a problem with limb mobility after having received an MRI or MRA, you need to speak with your doctor immediately. These symptoms may be associated with an underlying kidney or liver problem and the development of NSF or NFD.

What is the problem?

The U.S. Food and Drug Administration (FDA) has requested the manufacturers of gadolinium-based contrast agents to add a new boxed warning on the product labeling because of new reports linking the agents to a life-threatening skin disorder.

The requested boxed warning would state:

“Patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, and a potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF). In addition, it would state that patients just before or just after liver transplantation, or those with chronic liver disease, are also at risk for developing NSF if they are experiencing kidney insufficiency of any severity.”

What are Gadolinium Based Contrast Agents?

Gadolinium-based contrast agents are often used to improve the visibility of internal structures when patients undergo an MRI or MRA. These gadolinium based contrast agents are injected into veins of the patient so that the physician can view a clear and detailed picture of a patient’s internal organs, tissues, bones and/or vessels.

Five gadolinium-based contrast agents have been approved for use in the United States:

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

What is the MRI or MRA used for?

Magnetic Resonance Imaging (MRIs) and Magnetic Resonance Angiography (MRAs) are typically ordered by physicians in order to detect abnormalities such as tumors, clots, bleeds, and related medical problems.

What is Nephrogenic Systemic Fibrosis (NSF)?

Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), is a skin condition that is often described as a swelling and tightening of the skin, usually limited to the extremities. The condition may develop over a short period of days or could take weeks to fully develop. Severely affected patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. Complaints of muscle weakness are common.

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