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FDA: New Warnings Required on Use of Gadolinium-Based Contrast Agents
Date:9/9/2010

rtain agents among patients at highest risk for nephrogenic systemic fibrosis," said Rafel (Dwaine) Rieves, M.D., director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research.

To further enhance the safe use of the imaging agents, the FDA recommends that health care professionals:

  • Estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function
  • Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the imaging is essential and not available without contrast
  • Monitor for signs and symptoms of NSF if a GBCA is administered to a patient with acute kidney injury or chronic, severe kidney disease
  • Administer a GBCA only once during an imaging session

Magnevist is marketed by Bayer Healthcare, Omniscan by GE Healthcare, and Optimark by Covidien.

For more information:

Gadolinium Safety Announcement

http://www.fda.gov/Drugs/DrugSafety/ucm223966.htm

Questions and Answers on Gadolinium-Based Contrast Agents

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142889.htm

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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