FDA: SimplyThick Should Not Be Used in Premature Infants

Product possibly linked to necrotizing enterocolitis in some infants

MONDAY, May 23 (HealthDay News) -- The U.S. Food and Drug Administration has notified parents, caregivers, and health care providers not to administer SimplyThick to infants born prior to 37 weeks, as the product may cause necrotizing enterocolitis (NEC), a life-threatening gastrointestinal condition.

SimplyThick is a thickening agent used for the management of swallowing disorders that is added to the feeding regimens of infants. On May 13, the FDA was made aware of adverse events possibly linked to the product. Currently, the agency has been made aware of 15 cases of NEC (including two deaths) in premature infants who were fed SimplyThick from at least four different U.S. medical centers.

The FDA notes that these reactions were unusual because NEC most often occurs in babies in the hospital early in their premature course. However, the illnesses reported to the FDA included premature infants who were discharged from the hospital to home on a feeding regimen that included SimplyThick and then became sick at home. SimplyThick is sold in packets of individual servings and in 64-ounce dispenser bottles and is available from U.S. distributors and local pharmacies.

According to the FDA, "health care providers should stop administering the product to premature infants. Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider."

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