FDA issues safety warning for iodinated contrast media use in children
The. U.S. Food and Drug Administration has issued a new warning pertaining to the use of iodinated contrast media in pediatric patients.
On March 30, the FDA released new prescribing information and monitoring recommendations for children 3 years old and younger who receive intravenous iodinated contrast media for various medical imaging procedures, such as computed tomography scans. The new warning regards the entire class of iodinated contrast media (ICM) injections.
The drug safety communication came after the FDA’s recent review of published studies that cite concerns for patients’ thyroid after ICM administration. The warning describes potential risks of underactive thyroid or a temporary decrease in thyroid hormone levels after pediatric patients undergo contrast-enhanced imaging, particularly in at-risk individuals.
“Certain pediatric patients are at an increased risk, including those who are newborns or have very low birth weight, prematurity, or the presence of cardiac or other conditions such as those requiring care in neonatal or pediatric intensive care units,” the statement reads. “Patients with cardiac conditions may be at greatest risk since they often require high doses of contrast during invasive cardiac procedures.”
The FDA recommends that providers monitor these patients directly after ICM administration and to consider checking thyroid function within 3 weeks of the exam, especially in preterm neonates and children who may have other underlying health conditions. If tests uncover thyroid dysfunction, providers should continue to monitor patients for any emerging signs that could signal future cognitive or behavioral disabilities. Though these issues are uncommon, it is necessary to identify and treat them as early as possible.
Parents, providers and healthcare professionals are encouraged to report any adverse events or side effects after ICM administration to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by submitting reports online or calling 800-332-1088 to request a reporting form.
The entire safety communication can be viewed here.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.