Drug Information Update- New Drug Safety Communication on iodine-containing contrast agents

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration (FDA) is advising 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. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads us to believe that this rare occurrence is usually temporary and resolves without treatment or any lasting effects.

We have approved changes to the labels of all iodinated contrast media (ICM) products to include information about these cases. We do not recommend changes to current prescribing, administration, or monitoring practices. We will continue to evaluate this issue and will update the public when we have additional information. Manufacturers of ICM products have been required to conduct a study to investigate this safety issue further.

For more information, please visit: iodine-containing contrast agents.