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New NSF Warnings Added to Gadolinium Contrast Dye Labels

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Bayer Healthcare’s Magnevist, GE Healthcare’s Omniscan, and Covidien’s Optimark are the gadolinium contrast dyes associated with the greatest risk of nephrogenic systemic fibrosis (NSF), according to a Food & Drug Administration (FDA) safety alert issued today. The labeling for these three gadolinium agents is being updated to warn that they are inappropriate for use among patients with acute kidney injury or chronic severe kidney disease.

All gadolinium contrast dye labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration, the FDA said.

Gadolinium-based contrast dyes are intravenous drugs approved by the FDA for use with magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) to help detect abnormalities of body organs, blood vessels, and other tissues. Since 2007, all gadolinium agents sold in the U.S. have carried the same black box warning – the FDA’s strongest safety notice – regarding the risk of NSF.

NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.

While not much is known about the disease, a growing mountain of evidence indicates that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes

In a statement, the FDA said the label changes announced today are intended to help ensure gadolinium dyes are used appropriately, and that patients at risk for NSF who receive these agents are actively monitored for the development of the disease.

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