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FDA calls for new warnings on MRI contrast agents

by Brendon Nafziger, DOTmed News Associate Editor | September 09, 2010
The U.S. Food and Drug Administration is slapping new warnings on gadolinium-based contrast agents and cautioning that three brands are associated with a greater risk of nephrogenic systemic fibrosis.

The FDA said Thursday that Magnevist (gadopentetate dimeglumine), Omniscan (gadodiamide), and Optimark (gadoversetamide injection) should not be used in patients with chronic, severe kidney disease or serious kidney injuries, because they were associated with the greatest risk of NSF. Magnevist is sold by Bayer Healthcare, Omniscan by GE Healthcare and Optimark by Covidien.

The new warnings update the boxed warnings about NSF risks the agency originally placed on contrast agents in 2007.
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"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," Dr. Rafel Rieves, the director of the FDA's medical imaging product division, said in prepared remarks.

The agency is also requesting that doctors perform kidney function tests on all at-risk patients before administering the agents. The other approved contrast agents, Ablavar (gadofoveset trisodium), Eovist (gadoxetate disodium), Multihance (gadobenate dimeglumine) and Prohance (gadoteridol), should not be administered on patients with suspected kidney problems "unless the imaging is essential and not available without contrast," the agency said. Ablavar is made by Lantheus Medical Imaging Inc., Eovist by Bayer and both Multihance and Prohance by Bracco Diagnostics Inc.

Doctors should also monitor patients with kidney disease for any signs of NSF, and tell patients to check for symptoms of NSF, such as burning, hardening or itching of the skin, the appearance of red or dark patches on the skin and stiffening of joints.

NSF, an extremely rare disorder characterized by excess fibrotic tissue building up in the skin, joints and internal organs, is thought to be associated with gadolinium-based contrast agents.

The first case of NSF was identified over a decade ago, but the link between the disease and gadolinium was first reported in May 2006, the FDA said. Several further studies have supported the link, the agency said, including a 2006 retrospective study with Omniscan in around 370 patients with severe kidney insufficiency, which found the NSF risk for these patients to be an estimated 4 percent.