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FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents

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FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents

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FDA Requires New Class Warnings for All Gadolinium-Based Contrast Agents
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    The FDA announced that it is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for MRI.
    • Overview

      The FDA announced that it is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (or MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs.

      Report side effects involving GBCAs to FDA’s MedWatch program at www.fda.gov/medwatch.

      A link to the full communication detailing specific information for health care professionals and a list of FDA approved GBCAs can be found at www.fda.gov/DrugSafety

      Released 12/19/2017

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    Programs 8/24/19

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