FDA: Reports of Underactive Thyroid in Infants After Iodinated Contrast Media Use

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The FDA has issued a drug safety communication regarding iodine-containing contrast agents in infants.

The United States Food and Drug Administration (FDA) issued a drug safety communication stating that rare cases of underactive thyroid in infants have been reported after the use of iodinated contrast media (ICM) used for medical imaging procedures.

Ten cases of underactive thyroid have been reported between 1969 and 2012 in infants aged younger than 4 months who received ICM, according to the FDA Adverse Event Reporting System (FAERS) database.

Several of the infants received a topical iodine product, which may have contributed to the underactive thyroid, in addition to ICM, but this product is no longer recommended for infants, the agency stated in the communication. 

All of the infants with underactive thyroid were diagnosed within a month after receiving an ICM product. Some of the infants required treatment to improve the condition and some infants improved without treatment.

The FDA advises that parents and caregivers should contact a healthcare professional if they have concerns about their baby undergoing a procedure involving ICM. Healthcare professionals should follow label recommendations for ICM products and use clinical judgment to determine whether testing for underactive thyroid is necessary.

“We have approved changes to the labels of all iodinated contrast media (ICM) products to include information about these cases,” the FDA noted in their statement. “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.”

The FDA will require manufacturers of ICM products to conduct a study to determine how often underactive thyroid occurs with ICM use, how long the condition lasts, and if any further treatment is required.


  1. FDA Drug Safety Communication: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging. U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/DrugSafety/ucm472782.htm. Published November 17, 2015. Accessed November 18, 2015.