Gadolinium Lawyer

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FDA Warning on Gadolinium-based Agents

October 29th, 2007 · No Comments

As of May 23, 2007 the U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).Warnings would state that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a potentially fatal disease known as nephrogenic systemic fibrosis (NSF).  Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. The cause of NSF is not known and there is no consistently effective treatment of this condition.

Patients should be screened for kidney problems prior to receiving one of these imaging agents. The recommended dose should not be exceeded and enough time should elapse to ensure that a dose has been eliminated from the body before the agent is used again.  There have been no reports of NSF among patients with normal kidney function or those with mild-to-moderate kidney insufficiency. 

Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents. The reports have not always identified a specific agent however; Omniscan was the most commonly reported agent.

To learn more, please contact Gadolinium Lawsuit Lawyers at Williams Kherkher by calling 1.800.220.9341.

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