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FDA officials warn against food thickener for preemies

FDA officials are discouraging parents of premature infants from feeding them a food-thickening agent, after receiving 15 reports of necrotizing enterocolitis, including two deaths, in infants that may be associated with this product.

FDA officials said they were not recalling the product, which is designed to make liquids easier to swallow.

On its website, the manufacturer, SimplyThick of St. Louis, encouraged those to follow the FDA recommendation and said it was working with the FDA to investigate the reports. The newborns had been fed the product for various lengths of time, and typically, it had been mixed with mothers’ breast milk or infant formula products.

“The current situation is unusual because necrotizing enterocolitis most often occurs in babies within the hospital, early in their premature course,” FDA officials said in a press release, adding that some of the babies had been discharged from the hospital.

Signs and symptoms of necrotizing enterocolitis include appearance of a bloated abdominal area, appearance of illness, feeding intolerance, greenish-tinged (bile) vomiting and bloody stools.

The product is sold in single-serving packets and 64-oz dispensers. The product can be purchased from distributors and local pharmacies throughout the United States.

Simply Thick officials asked those wanting more information to call 800-205-7115 or email latestinfo@simplythick.com.

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