FDA Launches Probe into Safety of Common MRI Contrast Agent

By Rheingold, Giuffra, Ruffo & Plotkin LLP of Rheingold, Giuffra, Ruffo & Plotkin LLP posted in FDA on Tuesday, October 13, 2015.

A startling amount of research suggests deposits of gadolinium-based contrast agents (GBCAs) remain in the brain after repeat MRI procedures, prompting the FDA to investigate the products' safety and risks.

The agency plans to work with its National Center for Toxicological Research (NCTR), as well as the research industry and community, to determine why gadolinium deposits build up in the brain and assess any adverse effects.

In a statement released by the FDA, research has found that deposits of GBCAs stay in the brain after 4 or more contrast MRI scans, but whether the deposits are indeed harmful remains unclear.

Until more information is uncovered, healthcare professionals are urged to limit their use of GBCA products to "clinical circumstances in which the additional information provided by the contrast is [absolutely] necessary."