Dotarem approved for nervous system MRIs

(HealthDay)—Dotarem (gadoterate meglumine) has been approved by the U.S. Food and Drug Administration as a contrast agent for use in MRIs of the brain, spine and other parts of the central nervous system.

Approved for people two years and older, the imaging agent helps radiologists detect lesions and other abnormalities. Dotarem and similar agents all carry a boxed label warning of the risk of nephrogenic systemic fibrosis, a rare yet dangerous condition that can develop in people with kidney disease, the FDA said in a news release. The condition is characterized by pain and thickening of the skin.

Dotarem's safety and effectiveness were evaluated in clinical studies involving 245 adults and 38 children with suspected abnormalities of the . All side effects were rare, the agency said, but the most common ones included nausea, headache, a , and injection-site pain and coldness.

Dotarem is marketed by Guerbet LLC, based in Bloomington, Ind.


Explore further

Iclusig approved for rare leukemias

More information: The FDA has more about this approval.

Health News Copyright © 2013 HealthDay. All rights reserved.

Citation: Dotarem approved for nervous system MRIs (2013, March 21) retrieved 23 October 2021 from https://medicalxpress.com/news/2013-03-dotarem-nervous-mris.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
 shares

Feedback to editors