FDA announces new warning, guidelines for gadolinium-based contrast agents
The FDA issued a new Drug Safety Communication Tuesday that requires a warning to be placed on all gadolinium-based contrast agents (GBCAs) for MRI use. The warning should alert providers about the possibility that gadolinium could be retained in the patient’s body, including their brain, for an extended period of time after MRI.
“Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks,” the FDA wrote. “However, after additional review and consultation with the Medical Imaging Drugs Advisory Committee, we are requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems.”
In addition, the FDA will also now require patients to receive a Medication Guide with key information before receiving a GBCA. And GBCA manufacturers must now “conduct human and animal studies to further assess the safety of these contrast agents.”
Providers are also advised to consider potential retention-related issues when choosing GBCAs for patients at a higher risk for retention, including patients requiring multiple doses over the course of their lifetime, pregnant women, pediatric patients and “patients with inflammatory conditions.”
Additional Radiology Business coverage of gadolinium and GBCAs can be found here and here.
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.