FDA Approves Gadolinium-based Contrast Agent for MRI

The FDA has approved gadolinium-based contrast agent Dotarem (gadoterate meglumine) for MRI of the brain, spine and associated tissues of patients ages 2 and older.

“Today’s approval provides doctors with another option to help evaluate anatomic abnormalities within the central nervous system,” Dwaine Rieves, MD, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, said in a release.

Dotarem, marketed by Bloomington, Ind.-based Guerbet LLC, was found to be safe and effective in a clinical trial of 245 adult and 38 pediatric patients with suspected central nervous system abnormalities. Each patient received a baseline MRI without Dotarem, then a repeated MRI following Dotarem administration.

Compared to the baseline images, Dotarem MRI helped radiologists better see central nervous system lesions, the FDA said. Dotarem also helped the radiologists identify lesion borders and other features. Similar results were obtained in a clinical trial conducted among patients who were known to have central nervous system abnormalities.

Dotarem has been commercialized widely throughout the world since 1989 and is the only macrocyclic and ionic gadolinium-based contrast agents (GBCA ), according to Guerbet.

"This approval is a major milestone for Guerbet, which has a proud history of providing safe and effective contrast agents to patients worldwide," Yves L'Epine, CEO of Guerbet Group, said in a statement. "Dotarem,  already a leader in Europe, is a compelling new CNS imaging option for US healthcare providers and enriches our portfolio for improved patient management with diagnostic imaging in the US."

All GBCAs, including Dotarem, carry a boxed warning about the risk of nephrogenic systemic fibrosis, characterized by pain and thickening of the skin, and can cause fibrosis of internal organs. Side effects to Dotarem were uncommon in clinical trials. The most commonly reported side effects were nausea, headache, pain or coldness at the injection site, and burning sensation.

Dotarem is the seventh GBCA approved by the FDA for use in patients undergoing central nervous system MRI. Others include Magnevist (1988), Prohance (1992), Omniscan (1993), Optimark (1999), Multihance (2004) and Gadavist (2011).