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Information on Gadolinium-Containing Contrast Agents

The issue described in this communication has been addressed in product labeling, please see Drugs@FDA

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).

Gadolinium-Containing Contrast Agents: Labeling and Regulatory History from Drugs@FDA

Historical Information

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Date created: June 8, 2006; updated May 23, 2007