FDA Changes Label on Gadolinium-based Contrast Agents to Warn of Nephrogenic Systemic Fibrosis

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Gadolinium-based Contrast Agents: Class Labeling Change – Risk of Nephrogenic Systemic Fibrosis

What’s the problem?

September 10, 2010 – The FDA is now requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare but serious condition associated with the use of GBCAs in certain patients with kidney dysfunction. NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.

Gadolinium-based Contrast Agents (GBCAs)

GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography. The following is a list of popular contrast agents:

  • Ablavar (gadofosveset trisodium)
  • Eovist (gadoxetate disodium)
  • Magnevist (gadopentetate dimeglumine)
  • Multihance (gadobenate dimeglumine)
  • Omniscan (gadodiamide)
  • Optimark (gadoversetamide injection)
  • Prohance (gadoteridol)

Healthcare professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease.

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