News | Contrast Media | September 07, 2017

FDA Holds MIDAC Meeting on Gadolinium-Based Contrast Agents

Administration looks to solicit opinions and recommendations on regulatory approaches to administration of GBCAs

FDA Holds MIDAC Meeting on Gadolinium-Based Contrast Agents

September 7, 2017 — The U.S. Food and Drug Administration (FDA) held a meeting of the Medical Imaging Drugs Advisory Committee (MIDAC) on Sept. 8 to discuss regulatory approaches for use of gadolinium-based contrast agents (GBCAs).

In a statement, the administration said, “FDA has convened this advisory committee to seek opinions and recommendations on regulatory approaches to the issue of gadolinium retention in the brain and other body organs following administration of gadolinium based contrast agents (GBCAs). The evidence indicating retention following the use of GBCAs has led to concerns that gadolinium retention may cause adverse reactions, if not immediately then at some later date. FDA will ask the committee to focus on scientific facts; observational data; nonclinical, clinical and epidemiological study findings; post-marketing adverse event reports; and regulatory requirements in considering its responses to FDA questions.”

The statement continued, “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.

We now seek advice from the committee on the strength of the scientific evidence that would support potential regulatory actions such as labeling changes in relation to gadolinium retention. We also seek suggestions on the design of further epidemiologic and other studies to investigate potential adverse events associated with gadolinium retention in humans...”

The statement concluded, “…It is important to note that FDA’s intention in convening the current Advisory Committee is to solicit advice limited in scope to safety issues surrounding post-GBCA gadolinium retention in patients with normal renal function.”

The FDA’s decision to convene the MIDAC on this topic follows the May 22, 2017 update to its previous Drug Safety Communication entitled “FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue.”

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

FDA Approves Bayer's Gadavist Contrast for Cardiac MRI in Adult Coronary Artery Disease Patients
Technology | Contrast Media | July 15, 2019
The U.S. Food and Drug Administration (FDA) has approved Gadavist injection for use in cardiac magnetic resonance...
ITN Wins Jesse H. Neal Award for Best Technical Content
News | Radiology Business | April 24, 2019
April 24, 2019 — Imaging Technology News (ITN) was recently named the 2019 Jesse H.
Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Feature | Contrast Media Injectors | April 11, 2019 | By Jeff Zagoudis
One of the most controversial issues in radiology in recent years has been the use of...
Non-Contrast MRI Effective in Monitoring MS Patients
News | Neuro Imaging | March 18, 2019
Brain magnetic resonance imaging (MRI) without contrast agent is just as effective as the contrast-enhanced approach...
Ultrasound Societies Urge FDA to Remove "Black Box" on Ultrasound Contrast Agents
News | Ultrasound Imaging | March 07, 2019
National and international ultrasound societies are urging the U.S. Food and Drug Administration to remove the “black...
Sponsored Content | Case Study | Contrast Media | January 30, 2019
The medical imaging market relies heavily on contrast media, injected into patients to increase the contrast of bodil
Sponsored Content | Videos | Contrast Media | January 22, 2019
ITN Contributing Editor Greg Freiherr speaks with Guerb
Videos | Artificial Intelligence | December 21, 2018
Enhao Gong, Ph.D., founder of Subtle Medical, an artificial intelligence (AI) company that develops products to help
Guerbet Showcases Diagnostic and Interventional Imaging Solutions at RSNA 2018
News | Interventional Radiology | December 12, 2018
Guerbet LLC USA highlighted new and next-level product offerings and partnerships in contrast media, injectors,...
Guerbet Launches Multi-Use OptiVantage Contrast Media Injector in Europe
Technology | Contrast Media Injectors | December 05, 2018
Contrast agent company Guerbet recently announced that the OptiVantage multi-use contrast media injector is now CE...