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Gadolinium MRI/MRA Contrast Dye
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FDA Safety Alert Underactive Thyroid following use of Contrast Agents in Infants

Nov 18, 2015

The U.S. Food and Drug Administration (FDA) has issued a safety alert noting that "rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called 'contrast dye,' for X-rays and other medical imaging procedures." The agency stated that the infants were all premature or had other serious underlying health issues. The labels of all iodinated contrast media (ICM) will be updated to include information about the underactive thyroid cases. The FDA believes the occurrence is rare and usually temporary without lasting side effects, according to the alert.

Contrast dye is used in medical imaging to visualize blood vessels and organs on medical images. It is utilized in medical imaging techniques such as X-ray and computed tomography (CT) scans. If parents or caregivers are concerned, they should contact the child's health care provider. Generally, an underactive thyroid will not present any visible symptoms in infants.

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