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

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FDA Drug Information Updates

ReachMD

20 episodes

7 months ago

Experts from the U.S. Food and Drug Administration (FDA) discuss important new drug information as well as urgent insights about approved drug products.

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Medicine

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Experts from the U.S. Food and Drug Administration (FDA) discuss important new drug information as well as urgent insights about approved drug products.

Science

Medicine

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

FDA Drug Information Updates

7 years ago

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

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