FDA to Require Warning Labels on Gadolinium-Based Contrast Agents

Megan Brooks

Disclosures

December 19, 2017

The US Food and Drug Administration (FDA) will require a new class-wide warning for all gadolinium-based contrast agents (GBCAs) regarding gadolinium remaining in the body for months or years after receipt of the agent, the agency said in an updated drug safety communication issued today.

The FDA will also require a new medication guide that providers should give to patients in advance of receiving a GBCA. And GBCA manufacturers will be required to conduct further studies to assess the safety of this class of contrast agents.

"The FDA reviewed available data about the retention of gadolinium from gadolinium-based contrast agents as part of its role in monitoring the post-market safety of drugs," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement announcing the new actions.

"As a result of that review, we recommend that health care professionals consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk, such as those who may require repeat GBCA MRI scans to monitor a chronic condition," she said.

The linear and macrocyclic GBCAs approved by the FDA are listed below. Linear GBCAs result in more gadolinium retention in the body than do macrocyclic GBCAs, the agency notes.

Table. FDA-Approved GBCAs

Brand Name Generic Name Chemical Structure
Dotarem Gadoterate meglumine Macrocyclic
Eovist Gadoxetate disodium Linear
Gadavist Gadobutrol Macrocyclic
Magnevist Gadopentetate dimeglumine Linear
MultiHance Gadobenate dimeglumine Linear
Omniscan Gadodiamide Linear
OptiMARK Gadoversetamide Linear
ProHance Gadoteridol Macrocyclic

 

In 2015, the FDA first alerted health providers that they were investigating the risk associated with gadolinium deposits in the brain following repeated use of GBCAs for MRI.

In September 2017, the FDA's Medical Imaging Drugs Advisory Committee voted in favor of adding a warning to labels about gadolinium retention for GBCAs used during MRI, as reported by Medscape Medical News.

In the updated drug safety communication issued today, the FDA notes that gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function. The FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks.

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