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The FDA has required manufacturers of a specific contrast agent used in magnetic resonance imaging (MRI) to post a new “black box” warning on the product. A “black box” warning is the highest level of warning that the FDA can issue. The warning is a result of hundreds of cases of a rare but dangerous skin disease being reported in association with gadolinium-based contrast agents. These agents are used to enhance MRI images, but can have catastrophic results when given to persons suffering from kidney disease.

The skin disease, nephrogenic systemic fibrosis, is characterized by thickening of the skin inhibiting a persons movement and can result in broken bones. Organs have also been shown to be a t risk of thickening. There has been very little success treating the condition and the cause is not known.

The first notification by the FDA was in June of 2006 and has since been reiterated and expanded upon several times.

“FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease,” said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research. “This latest action demonstrates FDA’s continuing vigilance about ensuring the safety of drug products once they enter the marketplace.”

There have been over 215 reported cases thus far but many doctors believe the disease is under recognized. There have been no reports of complications with gadolinium-based agents in persons with normal kidney function.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.

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