News | Contrast Media | September 12, 2017

FDA Committee Votes to Expand Warning Labels on Gadolinium-Based Contrast Agents

Medical Imaging Drugs Advisory Committee (MIDAC) votes 13 to 1 to add warning of the possible risks of gadolinium retention

FDA Committee Votes to Expand Warning Labels on Gadolinium-Based Contrast Agents

September 12, 2017 — The U.S. Food and Drug Administration’s (FDA) Medical Imaging Drugs Advisory Committee (MIDAC) voted overwhelmingly last week to recommend new labels on gadolinium-based contrast agents (GBCAs) warning of the possibility of gadolinium retention in the body following administration during magnetic resonance imaging (MRI) exams. The labels will further explain that linear GBCAs carry a greater risk than macrocyclic agents, and that there is a greater risk for certain patient populations, according to Medscape.

The meeting, held Sept. 8, brought FDA officials together with healthcare professionals, industry representatives, patients and patient advocacy groups to discuss the merit of changing the regulatory approach for GBCAs. Representatives from Guerbet, Bayer, Bracco and GE Healthcare were all present at the meeting.

Concerns have emerged about gadolinium-based contrast agents in recent years as research has suggested that gadolinium is retained in the body, particularly in the brain, after administration and could cause adverse health effects, particularly for patients with renal failure. The FDA issued a Drug Safety Communication in May 2017 titled “No Harmful Effects Identified With Brain Retention,” in which the agency said it had not identified any adverse health effects from gadolinium retained in the brain, but that it would continue its review. 

In a statement released before the Sept. 8 meeting, the FDA said, “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.”

For more information: www.fda.gov

 

Related Content on MRI Gadolinium Retention in the Brain

FDA: No Harm in MRI Gadolinium Retention in the Brain

Recent Trends and Developments in Contrast Media

VIDEO: MRI Gadolinium Contrast Retention in the Brain

ISMRM Issues Guidelines for MRI Gadolinium Contrast Agents

Related Content

SyMRI Software Receives FDA Clearance for Use With Siemens MRI Systems
Technology | Magnetic Resonance Imaging (MRI) | June 14, 2019
SyntheticMR announced U.S. Food and Drug Administration (FDA) clearance for clinical use of its SyMRI Image and SyMRI...
A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse

Figure 1. A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse from Amsterdam Ph.D. researcher Gustav Strijkers.

News | Magnetic Resonance Imaging (MRI) | June 07, 2019
The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular...
Study Identifies MRI-Guided Radiation Therapy as Growing Market Segment
News | Image Guided Radiation Therapy (IGRT) | June 06, 2019
Revenues from the magnetic resonance imaging (MRI)-guided radiation therapy systems market exceeded $220 million in...
Ann Arbor Startup Launches Augmented Reality MRI Simulator
Technology | Virtual and Augmented Reality | June 04, 2019
SpellBound, an Ann Arbor startup specializing in augmented reality (AR) tools for children in hospitals, has officially...

Photo courtesy of Philips Healthcare

Feature | Radiology Business | May 31, 2019 | By Arjen Radder
Change is a consistent theme in our world today, no matter where you look.
MRI Metal Artifact Reduction Poses Minimal Thermal Risk to Hip Arthroplasty Implants
News | Magnetic Resonance Imaging (MRI) | May 23, 2019
Clinical metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) protocols at 3 Tesla (3T) on hip...
Henry Ford Hospital's ViewRay MRIdian linear accelerator system allows real-time MRI-guided radiotherapy. Shown is the support staff for this system. In the center of the photo is Benjamin Movsas, M.D., chair of radiation oncology at Henry Ford Cancer Institute. Second from the right is Carrie Glide-Hurst, Ph.D., director of translational research, radiation oncology.

Henry Ford Hospital's ViewRay MRIdian linear accelerator system allows real-time MRI-guided radiotherapy. Shown is the support staff for this system. In the center of the photo is Benjamin Movsas, M.D., chair of radiation oncology at Henry Ford Cancer Institute. Second from the right is Carri Glide-Hurst, Ph.D., director of translational research, radiation oncology.

Feature | Henry Ford Hospital | May 21, 2019 | Dave Fornell, Editor
Henry Ford Hospital thought leaders regularly speak at the radiation oncology and radiology conferences about new res
Videos | Radiation Therapy | May 21, 2019
This is a walk through of the ViewRay MRIdian MRI-guided radiotherapy system installed at ...
360 Photos | Magnetic Resonance Imaging (MRI) | May 17, 2019
This is a dedicated cardiac Siemens 1.5T MRI system installed at the Baylor Scott White Heart Hospital in Dallas.