FDA Officials Warn About MRI Dye

DECEMBER 19, 2017
FDA officials are requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, for months to years after receiving these drugs.

In a drug safety communication issued today, FDA officials noted that "gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and we have concluded that the benefit of all approved GBCAs continues to outweigh any potential risks."

However, FDA officials are now requiring a new patient medication guide, providing educational information that every patient will be asked to read before receiving a GBCA, and they are requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.

GBCAs, which contain a heav metal, are used with MRI scanners to examine the body for problems such as cancer, infections, or bleeding. These contrast agents are injected into a vein to improve visualization of internal organs, blood vessels, and tissues during an MRI, which helps health care professionals diagnose medical conditions. After being administered, GBCAs are mostly eliminated from the body through the kidneys. However, trace amounts of gadolinium may stay in the body long-term. Many GBCAs have been on the market for more than a decade.

"To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. We have also received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established," FDA researchers wrote in their communication.

Health care professionals are urged to report side effects involving GBCAs or other medicines to the FDA MedWatch program.