The U.S. Food and Drug Administration (FDA) this week announced it is requiring a new class warning and safety measures regarding gadolinium-based contrast agents (GBCAs) used in magnetic resonance imaging (MRI). In a release dated Dec. 19, FDA said it will require a new patient medication guide for every patient receiving a GBCA. It is also requiring GBCA manufacturers to conduct safety studies about the agents.
GBCAs are used in about one-third of MRIs to enhance the clarity and diagnostic accuracy of the images. Trace amounts of gadolinium may remain in the body long-term, which may pose a risk for people requiring multiple doses, children, pregnant women, and patients with inflammatory conditions. However, FDA has concluded that gadolinium is not directly linked to adverse outcomes in patients with normal kidney function, and that the benefit of GBCAs therefore outweighs its risks.
FDA recommends that providers consider the patient’s risk profile and minimize repeated GBCA studies when possible.
The FDA alert is available here:
FDA Warns That Gadolinium-Based Contrast Agents (GBCAs) Are Retained in the Body; Requires New Class Warnings
Curi has revised our MRI consent form to reflect this new risk. The form is available here:
For further guidance, Curi members are encouraged to contact our Risk Management Department at 800.662.7917.
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