September 22, 2017

MIDAC Supports Planned Gadolinium Contrast Warning

The Medical Imaging Drugs Advisory Committee (MIDAC) of the Food and Drug Administration (FDA) voted at a Sept. 8 advisory committee meeting to support an FDA plan to revise the prescribing information for gadolinium-based contrast agents (GBCAs) to include a warning for patient retention of all GBCAs.

The proposed warning would describe the relatively higher retention of all or some linear GBCAs compared to macrocyclic gadolinium contrast media in certain organs, including the brain. It would recommend risk minimization steps for certain patient population groups.

The panel also recommended the FDA should require manufacturers to conduct additional studies to inform future FDA decisions about the need for additional regulations including a possible withdrawal of approval and restriction of indicated populations.

MIDAC deliberations largely echoed a May 22 FDA Public Safety Announcement that recognized the issue of gadolinium retention in the brain and other body tissues, but noted that evidence to date fails to demonstrate adverse health effects from MRI gadolinium contrast media retention in the brain. There was also broad agreement among MIDAC members that GBCAs should be used only when indicated and only in the amounts necessary to yield the required diagnostic information.

Several MIDAC members and members of the public participating in the public comment period emphasized the lifesaving benefits of GBCA-enhanced MRI for disease, noting that millions of patients who receive GBCAs have no reports of adverse events. One industry presenter noted that 450 million doses of GBCAs have been administered since 1988.

Matthew Davenport, MD, chair of the ACR Contrast Committee, presented the ACR-American Society of Neuroradiology position statement on the use of gadolinium contrast agents, and reiterated the ACR statement that disagrees with the recommendation of the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency to suspend use of some GBCAs.