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Underactive Thyroid Can Occur in Infants Who Receive Iodine-containing Contrast Agents for Medical Imaging, FDA Warns

Filed November 19th, 2015 F.A. Kelley

In a safety communication to radiology and endocrinology health care professionals, the Food and Drug Administration (FDA) advises that in rare instances underactive thyroid has occurred in infants after the use of “contrast dye” for X-rays and other medical imaging procedures.

In all reported cases, the infant was either premature or had other serious underlying medical conditions. Based on available evidence, the FDA said it believes that this rare occurrence is usually temporary, resolves without treatment, and does not have any lasting effects.

The thyroid controls metabolism, and this affects many body functions, including heartbeat, body temperature, and how well the body burns calories. When an individual has too little thyroid hormone, body processes slow down and the metabolism becomes sluggish, WebMD explains. Continuing low thyroid in an infant may result in the baby not growing properly and having poor muscle tone and other symptoms.

Iodinated contrast media are administered during imaging procedures such as X-rays and computed tomography (CT) scans. The contrast media enhance the physician’s ability to see blood vessels and organs and the media provide greater detail in images to help health care professionals diagnose potential problems.

The FDA directed label changes for all iodinated contrast media (ICM) products to include information about the infant hypothyroid cases. But at this time, the FDA has not recommended any changes to current prescribing, administration, or monitoring practices for the products. The agency said it will continue to evaluate this issue and will issue further updates update the public when it has additional information. The FDA is requiring manufacturers of ICM products to conduct a study to further investigate this safety issue.

The FDA recommends that parents and caregivers contact their baby’s health care provider for additional information about the possibility of low thyroid or if they have concerns about their baby receiving an ICM product. Infants typically do not show any visible signs of underactive thyroid. Health care professionals should continue to follow the label recommendations for ICM products and should consider whether testing for underactive thyroid is necessary.

The FDA encourages health care professionals and parents to report adverse events or side effects related to the use of ICM products in infants. Reports can be made online, by mail, phone or fax to the MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.

 

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