Thread: New FDA warnings on MRI contrast agents:
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Old 09-09-2010, 03:16 PM
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mrsD mrsD is offline
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Join Date: Aug 2006
Location: Great Lakes
Posts: 33,508
15 yr Member
Arrow New FDA warnings on MRI contrast agents:
http://www.fda.gov/NewsEvents/Newsro.../ucm225286.htm

Quote:
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.
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TRESA (09-10-2010)