Product Liability: Gadolinium | MRI Contrast Agent | MRA Contrast Agent

Gadolinium MRI Contrast Agent


Nephrogenic Systemic Fibrosis (NSF) | Nephrogenic Fibrosing Dermopathy (NFD)

Gadolinium is an FDA-approved contrast agent for magnetic resonance imaging (MRI). Gadolinium is also called gadolinium-DPTA and gadodiamide, and it goes by various brand names. Gadolinium is non-radioactive and resembles plain water.

FDA REPORTS

FDA reports have identified a possible link between Nephrogenic Systemic Fibrosis (NSF) and/or Nephrogenic Fibrosing Dermopathy (NFD) and exposure to gadolinium containing contrast agents used at high doses for a procedure called Magnetic Resonance Angiography (MRA).

In particular, the FDA black box warning - updated on 5/23/2007 - reports that 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).

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

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

In addition, the FDA released an informational video on gadolinium based contrast agents.

To view the FDA video, click here - FDA Video: New Warnings for MRI Contrast Agents Containing Gadolinium.

NSF/NFD SIGNS

Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy is usually detected by possible swelling and tightening of the skin of the arms and legs. This is followed by thickening of the skin and, in severe cases, patients may not be able to walk or fully extend their arms, hands, legs and/or feet.

There are several symptoms associated with NSF/NFD, including:

  • Swelling, hardening and tightening of the skin.
  • Reddened or darkened patches on the skin.
  • Raised yellow spots on the whites of the eyes.
  • Joint stiffness.
  • Deep pains in the hip bones or ribs.

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