Rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, or contrast dye, for X-rays and other medical imaging procedures.
In every reported case, the infants were premature or had other serious underlying medical conditions. These rare occurrences usually are temporary, however, and resolve without treatment or any lasting effects, the FDA noted.
Ten cases of underactive thyroid were reported to the FDA Adverse Event Reporting System database between 1969 and early 2012 in infants younger than 4 months who received iodinated contrast media (ICM) products.
The FDA approved changes to the labels of all ICM products to include information about these cases. No changes to current prescribing, administration or monitoring practices are recommended. FDA will continue to evaluate this issue and update the public when there is additional information. The manufacturers have been required to conduct a study to investigate this safety issue further.
Health care professionals should continue to follow the label recommendations for ICM products and use clinical judgment to determine if testing for underactive thyroid is necessary.
Read the MedWatch safety alert, including a link to the FDA drug safety communication, which lists approved ICM products, at www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm472995.htm.
Health care professionals and patients can report adverse side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.
