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Gadolinium Contrast Agent Retention In Brain May Require Label Warning

 
• By Brenda Sandburg

US FDA advisory committee to consider whether regulatory actions such as a labeling change are needed and what studies could be done to investigate potential adverse events associated with gadolinium retention in the brain and other body organs.

Human brain illustrated with millions of small nerves - Conceptual 3d render

The US FDA says there is no clear connection between reported adverse events with gadolinium-based contrast agents and their retention in the brain, but the agency is considering adding a label warning and seeking input from an advisory panel as to whether this is an appropriate approach.

The agency is asking its Medical Imaging Drugs Advisory Committee to provide advice on the strength of the scientific evidence that would support potential regulatory actions, such as a labeling change, to gadolinium-based contrast agents (GBCAs). At its Sept

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