FDA: Monitor Babies & Young Children Who Receive Injections of Iodine-Containing Contrast Media
The FDA released a Drug Safety Communication on March 30, 2022 recommending that newborns and children through 3 years old have follow-up thyroid monitoring within 3 weeks after receiving injections of iodinated contrast media (ICM) for X-rays and other medical imaging procedures.1
FDA approved injectable ICM: iodixanol, iohexol, iopamidol, iopromide, iothalmate meglumine, and ioversol.
On November, 17, 2015, the FDA released a Drug Safety Communication advising that rare cases of underactive thyroid have been reported in infants following injections of ICM.2 Based on a recent review of published studies, the FDA is recommending that newborns and children through 3 years old have follow-up thyroid monitoring within 3 weeks after receiving injections of contrast media containing iodine. If thyroid dysfunction is detected, treat and monitor thyroid function as clinically needed.
Recommendations for Health Care Providers
- FDA recommends monitoring of pediatric patients from birth through 3 years for the possibility of hypothyroidism or a temporary decrease in thyroid hormone levels following exposure to iodinated contrast media (ICM). Consider evaluating thyroid function within 3 weeks, especially in term and preterm neonates. If thyroid dysfunction is detected, treat and monitor thyroid function as clinically needed.
- Thyroid dysfunction characterized by hypothyroidism or a temporary decrease in thyroid hormone levels has been reported after single exposure and multiple exposures to ICM.
- Pediatric patients from birth through 3 years warrant closer monitoring to prevent an underactive thyroid during early life that may harm motor, hearing, and cognitive development and may require transient T4 replacement therapy.
- Certain pediatric patients are at an increased risk, including newborns and those having 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. Patients with cardiac conditions may be at greatest risk since they often require high doses of contrast during invasive cardiac procedures such as catheterization and computed tomography (CT).
- Counsel parents and caregivers about the risk of their child developing hypothyroidism or a temporary decrease in thyroid hormone levels after receiving ICM and inform them that follow-up monitoring may be performed.
To help the FDA track safety issues with iodinated contrast media and other medications, please report adverse events to the MedWatch program recommended in the Indian Health Manual. Instructions for reporting can be found online at the NPTC Pharmacovigilance website.
- Food and Drug Administration. (2022). FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging .
- Food and Drug Administration. (2015). FDA Drug Safety Communication: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging .