FDA to Look at Gadolinium-based Contrast Agent, Known for MRI Health Risks

Berlin, GermanyA German pharmaceutical company recently announced that the US Food and Drug Administration (FDA) has accepted its application for a gadolinium-based contrast agent. Gadolinium-based contrast agents have been associated with MRI health risks in the past.

Bayer Schering Pharma AG says that the new contrast agent, Gadovist, is a non-ionic gadolinium-based contrast agent, according to a news release.

Previously, such MRI contrast agents have been shown to have adverse health effects in some people with kidney problems. Occasionally, those with such conditions have needed dialysis to expel the agents from their bodies.

Gadovist has not yet been approved by the FDA; the FDA has merely has accepted the Bayer product's application.

"If approved by the FDA, Gadovist 1.0 would complement our portfolio of contrast agents in the United States," said Hans Maier, Head of the Diagnostic Imaging business unit at Bayer Schering Pharma, in the release. "This submission to the FDA is an important milestone for us."