FDA Alert: Necrotizing Enterocolitis in Premature Infants Exposed to a Thickening Agent

FDA Alert: Necrotizing Enterocolitis in Premature Infants Exposed to a Thickening Agent

Brief Summary of Report:

FDA is advising health-care providers and consumers to refrain from using the thickening agent SimplyThick in premature infants. Two possibly related deaths have been reported.

This U.S. Food and Drug Administration (FDA) alert warns of a life-threatening bowel condition in premature infants that has been associated with eating SimplyThick, a thickening agent. This information is intended for public health officials, emergency medicine practitioners, pediatric health-care providers, and consumers. ISSUE:FDA notified parents, care givers, and health-care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks. This product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue. BACKGROUND:FDA first learned of adverse events possibly linked to the product on May 13, 2011. As of May 20, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers' breast milk or infant formula. Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants. SimplyThick was added to the feeding regimen of those infants, who later developed NEC, to help with swallowing difficulties stemming from complications of premature birth. The product is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States. RECOMMENDATION:Health-care providers should stop administering the product to premature infants. Parents and care givers who have questions or concerns related to the use of the product or who have medical concerns should contact their health-care provider. Please see the photographs at the link below for images of the product. Please read the MedWatch safety alert, including links to the Press Release and product photos, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm FDA is requesting that public health partners report cases of necrotizing enterocolitis in infants consuming SimplyThick to emergency.operations@fda.hhs.gov.