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November 17, 2015: FDA Alerts Public of Risk of Contrast Dye-Related Underactive Thyroid in Infants

As reported in a Safety Communication released by the U.S. Food and Drug Administration (FDA) on November 17, 2015, following the use of contrast media containing iodine, also called ā€œcontrast dye,ā€ on an infant, that infant may suffer from underactive thyroid. While these cases are rare, the adverse effects of underactive thyroid in infancy may include slow growth, significant intellectual disability, and developmental delays.

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Details of Contrast Dye-Related Underactive Thyroid in Infants

In every reported case, the underactive thyroid had developed in infants who were either premature or had other serious underlying medical conditions.

The labels of all iodine-containing contrast dyes have been changed in consideration of these cases.

The FDA is requiring manufacturers of iodine-containing contrast dyes to conduct a study to investigate iodine contrast dye-related underactive thyroid in infants further.

Iodine-containing contrast dyes are used for X-rays and other medical imaging procedures in order to provide greater detail when necessary to help health care professionals diagnose potential problems. To see FDA Approved Marketed Iodinated Contrast Media Products visit the FDA Safety Communication regarding contrast dye-related underactive thyroid in infants.

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