September 7, 2017 — The U.S. Food and Drug Administration (FDA) held a meeting of the Medical Imaging Drugs Advisory Committee (MIDAC) on Sept. 8 to discuss regulatory approaches for use of gadolinium-based contrast agents (GBCAs).
In a statement, the administration said, “FDA has convened this advisory committee to seek opinions and recommendations on regulatory approaches to the issue of gadolinium retention in the brain and other body organs following administration of gadolinium based contrast agents (GBCAs). The evidence indicating retention following the use of GBCAs has led to concerns that gadolinium retention may cause adverse reactions, if not immediately then at some later date. FDA will ask the committee to focus on scientific facts; observational data; nonclinical, clinical and epidemiological study findings; post-marketing adverse event reports; and regulatory requirements in considering its responses to FDA questions.”
The statement continued, “FDA’s approach has been educational: alerting the public and clinicians to the retention phenomenon but not issuing any restrictions on use because toxic effects in humans have not been established.
We now seek advice from the committee on the strength of the scientific evidence that would support potential regulatory actions such as labeling changes in relation to gadolinium retention. We also seek suggestions on the design of further epidemiologic and other studies to investigate potential adverse events associated with gadolinium retention in humans...”
The statement concluded, “…It is important to note that FDA’s intention in convening the current Advisory Committee is to solicit advice limited in scope to safety issues surrounding post-GBCA gadolinium retention in patients with normal renal function.”
The FDA’s decision to convene the MIDAC on this topic follows the May 22, 2017 update to its previous Drug Safety Communication entitled “FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue.”
For more information: www.fda.gov
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