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.

In a statement released in May 2007, the FDA announced that the new warning would state the risk of NSF in patients with severe kidney dysfunction who receive an injection of a gadolinium-based MRI dye prior to undergoing an MRI.

The agency added that the warning would also apply to liver disease or transplantation patients who experience kidney insufficiency.

Nephrogenic Systemic Fibrosis

NSF is a debilitating condition marked by a thickening of the skin and connective tissues, inhibiting movement and sometimes resulting in broken bones. The thickening may also affect internal organs. According to the FDA, there is no treatment for nephrogenic systemic fibrosis that is consistently effective.

Approved MRI Dyes

Gadolinium-based MRI dyes are contrast agents used to enhance the body’s internal structures during magnetic resonance imaging tests. The FDA has approved five gadolinium-based contrast agents:

  • Magnevist
  • Omniscan
  • OptiMARK
  • MultiHance
  • ProHance

What Patients Should Know

Numerous cases of nephrogenic systemic fibrosis have been reported in patients following MRI testing with a gadolinium-based dye. Healthcare professionals and the public were first informed of the risks associated with gadolinium-based MRI dyes in June 2006 and then again in December.

The FDA is urging that patients be screened for kidney problems prior to undergoing an MRI with one of these agents and is also warning against excessive or frequent doses of these agents.

Diagnosed with NSF? Contact a nephrogenic systemic fibrosis attorney today to learn more about your legal rights and options.

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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 »

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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.
Read More »