FDA Adds Contrast Agent Label Warning

Cheryl Clark, September 13, 2010

The U.S. Food and Drug Administration has set label requirements for gadolinium-based contrast agents used in MR imaging to minimize causing the rare but serious kidney dysfunction condition called nephrogenic systemic fibrosis.

"These label changes are intended to help ensure these drugs are used appropriately, and that patients at risk for NSF who receive GBCAs are actively monitored for the development of NSF," the agency says.

Symptoms that hospitals and physicians are asked to monitor include scaling, hardening and tightening of the skin, red or dark patches on the skin and stiffness.  NSF also can cause fibrosis of internal organs, which may lead to death, and there is no effective treatment for NSF.  So far, all reports of NSF have been in patients who already have abnormal kidney function.

In addition to abnormal kidney function, other factors that appear to put patients at greater risk include its use in patients who have an impaired ability to eliminate the drug, including patients with acute kidney injury, and repeat doses or higher than recommended doses of gadolinium contrast agents.

He American College of Radiology in June also issued guidelines.

According to the revised FDA-required label, health professionals will be required to:



  • Do not use three of the GBCA drugs—Magnevist, Omniscan and Optimark—in patients with acute kidney injury or severe chronic kidney disease.
  • Prior to administration of a GBCA, screen patients to identify those who have acute kidney injury or chronic severe kidney disease, who are at higher risk.
  • Use the clinical history to screen patients for features of acute kidney injury or risk factors for chronically reduced kidney function.
  • Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the need for diagnostic information is essential and not available with non-contrasted MRI or other alternative imaging technology.
  • Monitor for signs and symptoms of NSF after a GBCA is administered.
  • Do not repeat administration of GBCA during a single imaging session.


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