New FDA Drug Safety Communication on Iodine-Containing Contrast Media for Medical Imaging - Drug Information Update

If your email program has trouble displaying this email, view it as a web page. FDA Recommends Thyroid Monitoring in Babies and Young Children Who Receive Injections of Iodine-Containing Contrast Media for Medical Imaging Based on our recent review of published studies, the U.S. Food and Drug Administration (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, also called "contrast dye," for X-rays and other medical imaging procedures. Our review showed that underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon. However, the conditions should be identified and treated early when needed to prevent potential future complications. Newborns, particularly those born premature, and children in their first 3 years with underlying conditions such as heart issues may be at higher risk for problems of the thyroid, a gland in the neck that releases hormones that help control many of the body's functions. We have 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. 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. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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