Categorized | FDA Approvals

Dotarem Received FDA Approval For MRIs of Central Nervous System


210301What’s New: FDA has approved Dotarem (gadoterate meglumine) to be used as a contrast agent in MRIs of various parts of the central nervous system such as spine and brain.

Important Detail: The Food and Drug Administration of the United States said that the imaging agent has been approved for use among people 2 years and over. It makes it easy for radiologists to detect lesions and other nervous system irregularities. A boxed label warning also comes up with such agents that specify the risk of developing nephrogenic systemic fibrosis basically among kidney patients. Pain and skin thickening are the symptoms of this condition.

Nearly 38 kids and 245 adults were included in the clinical studies aimed at evaluating the safety and effectiveness of Dotarem.

Conclusion: Dotarem showed its effectiveness at easing the detection of abnormalities in central nervous system. Coldness, pain at injection site, a burning sensation, headache and nausea are the most common side effects linked to Dotarem.