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FDA Approves New MRI Contrast Agent

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Wayne, NJThe US Food and Drug Administration (FDA) recently approved a new MRI contrast agent called Gadavist for people having the imaging conducted on their central nervous system, HealthDay News reports.

According to the news provider, the FDA said that the gadolinium-based contrast agent is expected to help doctors identify lesions that affect cell barriers between the blood stream and the brain.

After evaluating the new contrast agent in two clinical studies that included a total of 657 patients, the FDA approved it for patients two years and older, the news source said.

Gadavist and similar contrast agents reportedly come with boxed warnings about the potential for nephrogenic systemic fibrosis (NSF) in patients with kidney issues. According to the FDA, Gadavist is expected to put patients at a lower risk of developing the rare condition than similar contrast agents.

During testing, the most common side effects of the new contrast agent included nausea, headaches and "hypersensitivity" reactions, according to the FDA.

The news source reports that Gadavist is manufactured by Wayne, New Jersey-based Bayer Pharmaceuticals.


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