FDA Issues Warning on Contrast Dyes After Reports of Hypothyroidism
The Food and Drug Administration (FDA) is advising healthcare professionals about rare cases of underactive thyroid reported in infants following the use of iodinated contrast media (ICM), or contrast dyes, for X-rays and other medical imaging procedures.
The reported cases involved infants who were either premature or had other serious underlying medical conditions. The underactive thyroid diagnosis was made within a month of receiving ICM products. The FDA is led to believe, from available evidence, that this rare occurrence is usually temporary and resolves without treatment or any lasting effects.
Following these reports, the FDA has approved changes to the labels of all ICM products to include information about these rare cases. No changes to current prescribing, administration, or monitoring practices are recommended. The FDA also required manufacturers of ICM products to conduct a study to investigate this safety issue further.
The FDA will continue to evaluate this issue and will update the public when additional information is available. Healthcare professionals are encouraged to report ICM-related adverse events to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
For more information call (855) 543-3784 or visit FDA.gov.