Skip to Content

Join the 'Oraltag' group to help and get support from people like you.

Oraltag News

FDA Medwatch Alert: Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants

Posted 17 Nov 2015 by Drugs.com

ISSUE: FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads FDA to believe that this rare occurrence is usually temporary and resolves without treatment or any lasting effects. See the Drug Safety Communication for a data summary and a list of approved Approved Iodinated Contrast Media Products. FDA approved changes to the labels of all iodinated contrast media (ICM) products to include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended. FDA will continue to evaluate this issue and will update the public when there is ... Read more

Related support groups: Diagnosis and Investigation, Isovue-370, Optiray 320, Omnipaque 350, Iohexol, Visipaque, Ioversol, Isovue-300, Gastrografin, Hypaque, Cysto-Conray II, Conray, Omnipaque 240, Optiray 350, Omnipaque 300, Cysto-Conray, Diatrizoate, Iopamidol, MD-Gastroview, Iothalamate

Ask a Question

Further Information

Related Condition Support Groups

Body Imaging

Oraltag Patient Information at Drugs.com