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    FDA Issues New Warnings for Gadolinium-based Contrast Agents

    September 10, 2010

    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.

    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.

    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

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    FAQs on Gadolinium-based Contrast Agents (GBCAs)