AUDIENCE: Pediatrics, Radiology, Health Professional, Patient, Caregiver, Pharmacy
ISSUE: The FDA approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring recommendations for children 3 years or younger. The warning describes the risk of underactive thyroid or a temporary decrease in thyroid hormone levels. These risks and recommendations pertain to ICM given as an injection through an artery or vein.
BACKGROUND: ICM have been approved for decades and are drugs containing iodine given to patients to enhance the ability to see blood vessels, organs, and tissues on medical images such as X-rays or computed tomography scans. This results in detailed images that can help health care professionals diagnose potential problems.
Parents and caregivers should talk to your child’s health care professional for additional information or if you have any questions or concerns about your child receiving an ICM injection. Babies and young children typically do not show any visible signs of thyroid problems and may need to be monitored by their health care professionals after receiving ICM.
Health care professionals should perform appropriate monitoring of patients from birth through 3 years for the possibility of hypothyroidism or a temporary decrease in thyroid hormone levels following exposure to ICM. Consider evaluating thyroid function within 3 weeks, especially in term and preterm neonates and children with some underlying conditions. If thyroid dysfunction is detected, treat and monitor thyroid function as clinically needed to avoid future cognitive and other developmental disabilities.
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. Patients with cardiac conditions may be at greatest risk since they often require high doses of contrast during invasive cardiac procedures.
Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
[03/30/2022 - Drug Safety Communication - FDA]