FDA Approves Popular European MRI Contrast Agent Dotarem

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The U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine) as the first macrocyclic and ionic gadolinium-based contrast agent (GBCA) that can be used in the United States.

Given intravenously, Dotarem helps detect and visualize areas with disruption of the blood brain barrier and/or abnormal central nervous system vascularity on MRI scans. Because of its stable profile, it is considered useful for people undergoing frequent MRIs with contrast and children. It is approved for patients 2 years of age and older.

The biggest risk is nephrogenic systemic fibrosis (NSF), and Dotarem should not be used in patients with impaired renal function unless absolutely necessary, its maker says.

Dotarem is a leading European MRI contrast agent, with 47 percent marketshare last year, according to the company. It has been in use since 1989 and is available in 70 countries in Europe, Asia, Africa, Middle East and South America. The Guerbet pharmaceutical group, which makes Dotarem, says 37 million doses of the contrast agent have been administered worldwide.