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FDA warns of rare risk for underactive thyroid in children administered iodine contrast dye
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The FDA has issued a safety alert regarding rare cases of underactive thyroid reported among children after the use of contrast dye or contrast media containing iodine intended for medical imaging.
The alert also said all reported cases were in infants who were born prematurely or had other serious medical conditions. Complications related to use of the iodinated contrast media (ICM) are typically temporary and resolve themselves, the FDA said.
According to the alert, the FDA has approved additional label indications to all ICM products, which will include information about reported adverse events. The FDA does not currently recommend any changes to prescribing, administration or monitoring practices for the contrast agents.
The FDA said there have been 10 cases of underactive thyroid reported between 1969 and 2012 among children aged younger than 4 months who received ICM within 1 month of diagnosis. Some of these children, however, received a topical iodine product no longer recommended for use in children that may have caused the thyroid complications.
Parents are advised to contact their child’s health care providers with concerns related to ICM. Physicians and imaging professionals are advised to follow current label recommendations and to use their best clinical judgment to determine if follow-up testing is required for underactive thyroid, the FDA said.
The FDA has asked health care professionals and patients to report adverse events or side effects related to the use of ICM to the agency’s MedWatch Safety Information and Adverse Event Reporting program at www.fda.gov/MedWatch/report.