The U.S. Food and Drug Administration approved a brand new MRI contrast agent called Dotarem that will be used to image the central nervous system (CNS) in adults and pediatric patients (2 years of age and older).

In an e-mail to DOTmed News, Guerbet LLC, the company that is marketing Dotarem, said it will be the only macrocyclic and ionic gadolinium-based contrast agent available in the U.S.

Imaging the CNS accounts for approximately 60 percent of contrast enhanced MRI exams.
Dotarem has been commercially available in Europe since 1989 when it was introduced. According to Guerbet, it's the leading contrast agent in Europe with 47 percent market share in 2012.

"The well-established efficacy and safety profile of our contrast agent will be positioned in the U.S. in similar ways as it is in the rest of the world," a Guerbet spokesperson said in the e-mail.

Besides Europe, Dotarem is also available in Asia, Africa, the Middle East, and South America.

According to a statement from the FDA, the agent's approval in clinical trials showed that in comparison to baseline images, Dotarem MRI helped radiologists better detect CNS lesions in 245 adults and 38 pediatric patients with CNS abnormalities. Dotarem also helped the radiologists identify lesion borders and other lesion features. Although reported side effects were uncommon in the trials, patients with kidney disease are advised not to take any gadolinium-based contrast, including Dotarem, because of the risks it poses.

Bloomington, Ind.-based Guerbet said that they plan to have Dotarem available to U.S. radiologists as soon as possible.

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