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FDA NEWS RELEASE

For Immediate Release: September 9, 2010
Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA: New warnings required on use of gadolinium-based contrast agents
Enhanced screening recommended to detect kidney dysfunction

The U.S. Food and Drug Administration is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF), if the drug is administered to certain patients with kidney disease.

Three of the GBCAs – Magnevist, Omniscan, and Optimark – will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration. 

GBCAs are intravenous drugs approved by the FDA for use with magnetic resonance imaging or magnetic resonance angiography to help detect abnormalities of body organs, blood vessels, and other tissues.

NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms of NSF can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. NSF may lead to death, especially if it involves body organs.

The FDA’s review of the safety of the most widely used GBCAs determined that Magnevist, Omniscan, and Optimark are associated with a greater risk than other GBCAs for NSF in certain patients with kidney disease. Data suggest that NSF may follow the administration of any GBCA and the FDA continues to assess the safety of each GBCA to better estimate its NSF risks.

“The FDA is requiring these labeling changes to enhance the safe use of gadolinium-based contrast agents, including avoidance of certain 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:

 

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