Dotarem Approved for Nervous System MRIs03/21/13
THURSDAY, March 21 (HealthDay News) -- 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
Dotarem's safety and effectiveness were evaluated in clinical
studies involving 245 adults and 38 children with suspected
abnormalities of the central nervous system. All side effects were
rare, the agency said, but the most common ones included nausea,
headache, a burning sensation, and injection-site pain and
Dotarem is marketed by Guerbet LLC, based in Bloomington,
The FDA has more about
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