Pharmacy Services

Iodinated Contrast Agents Can Cause Transient Thyroid Suppression in Infants

November 30, 2015

FDA issued an alert stating iodinated contrast agents may rarely cause thyroid suppression in infants. These agents are also called “contrast dye” or iodinated contrast media, and are used for procedures requiring enhanced imaging of organs and blood vessels. Iodinated contrast agents can be administrated orally, intravenously, or rectally. Iodinated contrast agents affected by this alert include:

  • Diatrizoate meglumine (Cystografin, Cystografin Dilute)
  • Diatrizoate meglumine and diatrizoate sodium (MD-76R)
  • Iodipamide meglumine (Cholografin Meglumine)
  • Iodixanol (Visipaque 270, 320)
  • Iohexol (Omnipaque 140, 180, 240, 300, 350)
  • Iopromide (Isovue-200, 250, 300, and 350; Isovue-M 200 and 300; Scanlux-300, and 370)
  • Iopromide (Ultravist 150, 240, 300, 320, 350)
  • Iothalamate meglumine (Conray, Conray 30, 43)
  • Ioversol (Optiray 240, 300, 320, 350)
  • Ioxaglate meglumine and ioxaglate sodium (Hexabrix)
  • Ioxilan (Oxilan-300, 350)

FDA received 10 reports of thyroid suppression in infants (less than 4 months old) who received iodinated contrast agents between 1969 and early 2012. All cases were either premature infants or full term infants with serious underlying cardiac conditions. Thyroid suppression was diagnosed within one month after iodinated contrast agent administration in 7 patients who received an intravenous agents, 1 patient who received a rectal agent, 1 patient who received an intravascular agent, and 1 breast feeding infant whose mother had received an iodinated contrast agent. Infants were usually asymptomatic, and hypothyroidism typically resolved without lasting effects. In the 10 reported cases, 4 patients received hypothyroid treatment.

Continue following the labeled recommendations for iodinated contrast agents and use clinical judgment to determine if hypothyroid testing is necessary. The labeling of all iodinated contrast agents will be updated to include warnings of hypothyroidism in infants, and the manufacturers are conducting additional safety studies. FDA will update the public when additional information is available. Advise caregivers to contact their pediatrician with any questions. Report adverse events to the FDA MedWatch program.

Additional information:

November 30, 2015; University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.