The U.S. Food and Drug administration (FDA) has advised that a few cases of underactive thyroid have been reported in infants following the use of iodinated contrast media for x-ray and other medical imaging procedures.
The cases occurred in infants who were premature or had other medical conditions, the agency said in a November 17 communiqué. Evidence suggests that the cases are rare and usually temporary; most appear to resolve without treatment or lasting effects, the FDA said.
The agency has approved changes to the labels of all iodinated contrast media products to include information about these cases; however, no changes are recommended in prescribing, administration, or monitoring practices for x-ray contrast. The FDA said it will continue to evaluate the issue and will deliver updates when additional information is available. Meanwhile, manufacturers of iodinated contrast products have been required to conduct a study to further investigate this issue.
The agency advises parents and caregivers to contact their child's healthcare professional for additional information or to ask questions about iodinated contrast. Healthcare professionals should continue to follow label recommendations and use their clinical judgment to determine if testing for underactive thyroid is needed, the FDA said.
The agency encourages healthcare professionals and patients to report adverse events or side effects through the FDA's MedWatch reporting system, or to call 800-332-1088.
