April 27, 2023

ACR-Backed FDA Action to Monitor Young At-Risk Children Who Receive Iodinated Contrast Media

At the urging of the American College of Radiology® (ACR®) and others, the US Food and Drug Administration will now recommend thyroid monitoring only for high-risk young children who receive intravascular iodine-containing contrast media for computed tomography (CT) or other endovascular procedures. These risk factors may include prematurity, very low birth weight, and underlying medical conditions affecting thyroid function.

Impacting children three years and younger, the FDA had previously adopted advisory labelling that was not patient-tailored but instead recommended universal testing of all young children with intravascular iodinated contrast material exposure, which may contribute to unwarranted testing, expense, and parent anxiety.

“I want to thank the FDA for thoughtfully reconsidering this matter and adopting a more patient-centered and tailored response consistent with scientific evidence presented by ACR experts," said Jonathan R. Dillman, MD, MSc, chair of the ACR Pediatric Quality and Safety Committee and member of the ACR Committee on Drugs and Contrast Media, and Commission on Pediatric Radiology. "The FDA’s recent action allows us to proactively protect the at-risk children, while allowing those unlikely to benefit from the prior well-intended action to avoid unnecessary care, travel, expense, and concern.” 

For more details on this important issue, please review the ACR Statement on Use of Iodinated Contrast Material for Medical Imaging in Young Children and Need for Thyroid Monitoring.