FDA’s MIDAC votes to add retention warning to gadolinium contrast agents

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New labels warning that gadolinium-based contrast agents (GBCAs) cause gadolinium retention in some organs and tissues when used during MRIs will soon be seen on bottles.

The U.S. Federal Drug Administration (FDA)’s Medical Imaging Drugs Advisory Committee (MIDAC) voted 13-1 in favor of adding the labels, with one abstention. The only dissenting vote was Alicia Toledamo, president of Biostatistics Consulting, calling the labeling proposition insufficient.

Six linear and three macrocyclic GBCAs are currently approved by the FDA.

According to the recommendations, the prescribing information should include “a warning for retention for all GBCAs with greater retention of all or some of the linear GBCAs compared to the macrocyclics in certain organs including the brain.”

"It was appropriate to state that there may be differences among these agents that need to be explored," said Michael Weisman, MD, a professor at the University of California. "It's also appropriate to state that risk strategies need to be looked at more carefully. There are populations that need to be addressed, such as those that may over utilize this type of contrast imaging."

Earlier this year, the FDA stated that a new review of gadolinium contrasting agents showed retention in organs. The FDA also added that retention is greater for linear over macrocyclic GBCs.

MIDAC heard from various industry experts, researchers and patients who were affected by gadolinium retention. Opinions were wide-ranging including one who dubbed it a “potential overreaction” to gadolinium retention. Other called the usage of gadolinium “essential “and “lifesaving.”

Gena Norris, wife of veteran actor Chuck Norris, also sent a statement addressing her battle with gadolinium deposition disease. She added she experienced a variety of symptoms including severe abdominal pain, tremors and confusion.

And in a 15-0 unanimous vote, MIDAC also voted to require the FDA to have manufacturers of such agents perform more studies to see if additional regulation on GBCAs is needed.

"It's clear we need more information," said Peter Herscovitch, MIDAC chair and director of the Positron Emission Tomography department at the U.S. National Institutes of Health (NIH).