FDA Issues New Class Warnings For GBCAs
The U.S. Food and Drug Administration recently issued a drug safety communication requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Earlier this year, the Agency determined the benefits associated with approved GBCAs outweighed any potential risks, as it has not been directly linked to any adverse health effects. However, following additional review with the Medical Imaging Drugs Advisory Committee, the FDA will now require manufacturers to take additional actions to notify health care providers and patients about gadolinium retention and preventative actions.
Health care professionals are encouraged to weigh the retention characteristics of each agent when selecting a GBCA for patients with a higher risk for gadolinium retention and to reduce repeated GBCA imaging studies when possible. GBCA manufacturers are also required to conduct additional human and animal studies to further evaluate the safety of these contrast agents. Read the full safety alert here.
Keywords: Gadolinium, Contrast Media, Advisory Committees, Pharmaceutical Preparations, United States Food and Drug Administration, Magnetic Resonance Imaging, Communication, Drug-Related Side Effects and Adverse Reactions, Health Personnel, ACC Advocacy
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