Other safety alerts
|
| |
| The United States: Drug Safety Communication: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging |
| |
The U.S. Food and Drug Administration (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.
FDA approved changes to the labels of all iodinated contrast media (ICM) products to include information about these cases. FDA does not recommend changes to current prescribing, administration, or monitoring practices. FDA will continue to evaluate this issue and will update the public when there is additional information. Manufacturers of ICM products have been required to conduct a study to investigate this safety issue further.
Parents and caregivers should contact their baby’s health care professional for additional information or if they have questions or concerns about their baby receiving an ICM product. Infants typically do not show any visible signs of underactive thyroid. The thyroid is a gland in the neck that releases hormones. Health care professionals should continue to follow the label recommendations for ICM products. They should continue to use their clinical judgment to determine if testing for underactive thyroid is necessary.
ICM are drugs containing iodine that are given to patients to enhance the ability to see blood vessels and organs on medical images such as X-rays or computed tomography (CT) scans. These images provide greater detail when necessary to help health care professionals diagnose potential problems.
A search of the FDA Adverse Event Reporting System (FAERS) database identified 10 cases of underactive thyroid reported between 1969 and early 2012 in infants younger than 4 months who received ICM. FAERS includes only reports submitted to FDA, so there may be additional cases about which FDA is unaware. In addition to ICM, several of these infants also received a topical iodine product that is no longer recommended for young infants, and that may have contributed to their underactive thyroids. All of the infants were diagnosed with underactive thyroid within a month of receiving ICM. Some infants were treated and improved while others improved without treatment.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm472782.htm
In Hong Kong, there are 15 registered pharmaceutical products which are ICM products under the brand names of Visipaque containing iodixanol (2 products), Omnipaque containing iohexol (2 products), Iopamiro containing iopamidol (4 products), Ultravist containing iopromide (2 products), Optiray containing ioversol (4 products) and Hexabrix containing meglumine ioxaglate and sodium ioxaglate (1 product). All products are prescription-only medicines. So far, the Department of Health has not received any adverse drug reaction case related to ICM products. In view of the above FDA announcement, letters to inform local healthcare professionals of the risk will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Wednesday, November 18, 2015
Issued at HKT 13:00
|
| |
|
