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FDA Okays New MRI Agent, Dotarem (Gadoterate Meglumine)
Seventh gadolinium-based contrast agent to win approval (Mar. 20)
The FDA has approved Dotarem (gadoterate meglumine, Guerbet LLC) for use in magnetic resonance imaging (MRI) of the brain, spine, and associated tissues of patients aged 2 years and older.
Dotarem is a gadolinium-based contrast agent (GBCA) that helps radiologists see abnormalities on images of the central nervous system (CNS) and surrounding tissues.
The agent’s safety and effectiveness were established in a clinical trial of 245 adult and 38 pediatric patients aged 2 years and older with suspected CNS abnormalities. Each patient received a baseline MRI without Dotarem, and then the MRI was repeated following Dotarem administration. The results showed that, in comparison with the baseline images, Dotarem MRI helped radiologists better see CNS lesions. Dotarem also helped the radiologists to identify lesion borders and other lesion features. Similar results were obtained in a clinical trial conducted in patients who were known to have CNS abnormalities.
All GBCAs, including Dotarem, carry a boxed warning about the risk of nephrogenic systemic fibrosis (NSF) — a rare but serious condition associated with the use of GBCAs in certain patients with kidney disease. NSF is characterized by pain and thickening of the skin, and can cause fibrosis of internal organs. There is no known treatment for NSF, and all approved GBCA labeling describes ways to minimize the risk of NSF. The most common adverse effects of Dotarem in clinical trials included nausea, headache, pain or coldness at the injection site, and a burning sensation.
Dotarem is the seventh GBCA approved by the FDA for use in patients undergoing CNS MRI. Other FDA-approved GBCAs with a CNS MRI indication include Magnevist (1988), Prohance (1992), Omniscan (1993), Optimark (1999), Multihance (2004) and Gadavist (2011).
Source: FDA; March 20, 2013.