FDA Warns of Underactive Thyroid in Some Infants Following Use of Contrast Dyes for Medical Imaging

The Food and Drug Administration (FDA) has advised a safety alert to health care providers about instances of underactive thyroid in infants after the use of “contrast dye” materials for X-rays and other medical imaging procedures.

In all reported cases, the agency says, the infant was either premature or had other serious underlying medical conditions. Based on currently available evidence, the FDA believes that these rare cases are usually temporary. Infants typically do not show any visible signs of underactive thyroid. The condition resolves without treatment and without any lasting effects.

The thyroid, WebMD explains, plays an important role in controlling metabolism, which affects such things as body temperature, heartbeat, and how well the body burns calories. When an individual has too little thyroid hormone, body processes slow down and the metabolism becomes sluggish. If low thyroid persists in an infant, the baby may not grow properly and may have poor muscle tone and other symptoms.

Iodinated contrast media (ICM) are drugs containing iodine that are administered to patients to enhance the ability to see blood vessels and organs on medical images such as X-rays or computed tomography (CT) scans. Contrast media provide greater detail in images and this helps health care professionals in making a diagnosis.

The FDA directed manufacturers of iodinated contrast media products to make label changes to include information about the infant cases. But at this time, the FDA did not recommend changes to prescribing, administration, or monitoring practices. The agency will continue to evaluate this issue and will update the public when there is additional information. Manufacturers of ICM products must 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 to discuss any concerns about the baby receiving an ICM product. Health care professionals should continue to follow the label recommendations for ICM products and should use their clinical judgment to determine if 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. 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.

 

from Parker Waichman http://www.yourlawyer.com/blog/fda-warns-of-underactive-thyroid-in-some-infants-following-use-of-contrast-dyes-for-medical-imaging/