FDA Warns Against Giving SimplyThick to Preemies
May 25, 2011
The U.S. Food and Drug Administration recently warned parents, caregivers and healthcare providers to stop using the thickening product SimplyThick in breast milk and formula given to babies born before 37 weeks. SimplyThick may cause necrotizing enterocolitis (NEC), a potentially life-threatening intestinal disorder, and it has been already been linked to 15 such cases, including two deaths.
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SimplyThick, a thickening agent for management of swallowing difficulties stemming from complications of premature birth, is most commonly given to preemies still in the hospital; illnesses have been reported to the FDA from at least four medical centers around the U.S. during the past six months. But, while NEC usually occurs in babies still hospitalized for treatment of prematurity complications, the FDA has learned that some of the affected babies had been discharged from the hospital and were on a feeding regimen that included SimplyThick at home, where they became ill.
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The FDA suggests that parents and caregivers of babies who received SimplyThick should be on the lookout for signs of NEC, which may include a bloated abdomen, feeding intolerance, greenish-tinged (bile) vomiting and bloody stools, as well as the rather ambiguous “appearance of illness.” Parents and caregivers who have questions or concerns related to SimplyThick should contact their healthcare provider. The FDA will continue to investigate the link between SimplyThick and these illnesses and deaths, and provide updates as additional information is available.
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SimplyThick is sold in single-serving packets and 64-ounce dispenser bottles to medical centers and consumers, both through distributors and local pharmacies throughout the U.S. See additional photos of SimplyThick product packaging and labels here.