FDA links seven fatalities to infant formula additive.

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Bloomberg News (9/19, Edney) reports that the Food and Drug Administration in a Consumer Update issued Tuesday, said, "seven babies died after being fed an additive used to help thicken infant formula or breast milk." The agency said the deaths were "among 21 premature infants and one born full-term that developed inflamed intestines after they were given SimplyThick." The FDA's Infant Formula and Medical Foods Staff Director Benson Silverman explained that the thickening gel "was designed to help premature babies swallow food and keep it down." He said the product is also used to help older children and adults "with swallowing problems caused by trauma to the throat." The FDA said the product, which comes in "individual serving packets and in 64-ounce dispenser bottles," is available "to consumers and at medical centers"; and it can also be "purchased from distributors and pharmacies."

        CNN (9/19, Young) in its "The Chart" blog notes that of the 22 infants who developed necrotizing enterocolitis after being fed SimplyThick, "half of the babies developed NEC while still in the hospital and the other half at home" and 14 of them "needed surgery." The agency initially warned of SimplyThick's "risk to premature infants" in May 2011; and FDA spokesperson Tamara Ward said it is "now extending that warning to all babies because it believes parents, caregivers and doctors will benefit from the information if considering whether to give the thickener to babies of any age."

        WebMD (9/19, Mann) adds that Ward said the FDA warning is "specific to SimplyThick and does not include other thickening products."