Tags: fda | thickening | agent | risk | simplythick

Regulators: SimplyThick Poses kid Danger

Friday, 21 Sep 2012 02:46 PM


The U.S. Food and Drug Administration is warning parents, caregivers and healthcare professionals that a thickening agent used to help patients manage swallowing difficulties can cause a life-threatening condition if given to infants.
The product, called SimplyThick, has been linked to 22 cases of infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed the thickening agent, the FDA said. Seven of those infants died.
FDA had issued an advisory in May 2011 that warned of the risk to infants born prematurely. Now, FDA is extending that advice to include infants on any age.
SimplyThick is available to consumers and medical centers. It is sold in individual serving packets as well as in 64-ounce dispenser bottles, purchased from distributors and local pharmacies throughout the United States.
Dr. Benson M. Silverman, director of FDA's Infant Formula and Medical Foods Staff, said the thickening agent is added to breast milk and infants' formula to help the premature babies swallow their food and keep it down, without spitting up. It is also used in older children and adults with swallowing problems caused by trauma to the throat.
FDA officials said further studies are needed to determine if consumption of SimplyThick causes the development of NEC. But agency officials said the warning is designed to alert anyone caring for a baby to be aware of the potential risk before deciding whether to feed SimplyThick to infants of any age.
Officials said infants with NEC may experience such symptoms as bloated stomachs, greenish-tinged vomit, and bloody stools.



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Regulators say a thickening agent used to treat swallowing difficulties can pose a danger to infants.
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Friday, 21 Sep 2012 02:46 PM
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