The specific label changes for GBCAs concerning retention, the FDA stated, are in the sections covering adverse reactions, pregnancy, clinical pharmacology, and patient instructions.

The announcement comes over 2 years after the agency had reported that it was investigating possible adverse gadolinium reactions.


In September, the Medical Imaging Drugs Advisory Committee voted to recommend revisions to the prescribing information after a public hearing at which, among others, the wife of action star Chuck Norris, Gena, recounted her own health struggles. After a series of scans with gadolinium, she suffered severe abdominal pain.

She has resorted to treating her condition with an expensive professional hyperbaric chamber.

"My heart breaks for those who don't have the financial means they need," she said. "We will continue to use our platform to raise awareness about the dangers of gadolinium."

That said, despite the risks of retention, Dr. Elizabeth Morris, past president of the Society of Breast Imaging and a breast radiologist at Memorial Sloan Kettering Cancer Center, called its use essential and a “lifesaving test."

The strongest – and only – dissenting vote on the panel came from Alicia Toledano, who is president of Biostatistics Consulting in Kensington, MD. She felt it did not go far enough.

"It is hard to dismiss an anecdotal report when you are the anecdote. A life ruined is a life ruined," she said. "What does a patient do when doctors and everyone she or he turns to for help 'pooh-poohs' his or her concerns and does not order a simple urine test? When a patient finally gets tested and is found to have gadolinium retention, there is no FDA-approved antidote. What does that patient do?"

She called the proposal “insufficient.”

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