ACR: FDA evidence backing thyroid monitoring in peds after ICM use is 'weak'

Maintaining that the evidence is “weak,” on June 7 the American College of Radiology refuted a recent FDA recommendation that children have their thyroid function monitored after exposure to intravenous iodinated contrast. 

The ACR statement comes on the heels of a safety communication from the U.S. Food and Drug Administration that was released in March 2022. In that communication, the FDA recommended that providers monitor the thyroid function of children aged three years and younger after the administration of intravenous iodinated contrast media (ICM). The statement indicated that certain children—newborns, those with low birth weight or those with cardiac conditions—are at an increased risk of a temporary decrease in thyroid hormone levels. 

To back this warning, the FDA cited 11 research studies that had been published from 1987 to 2020. After a deep dive into the details of these studies, the ACR published a statement suggesting that the FDA’s guidance on thyroid monitoring in this population of patients may be well-intentioned, but it lacks convincing supportive evidence. 

“At this time, the evidence is weak to support thyroid function monitoring in very low birth weight preterm infants, neonates, and infants with congenital heart disease,"  corresponding author of the statement Jonathan R. Dillman, MD, MSc, of the Cincinnati College of Medicine and Department of Radiology at Cincinnati Children’s Hospital Medical Center, and co-authors wrote. "The majority of existing studies suggest that any depression in thyroid function is usually transient and of uncertain clinical significance."