For Immediate Release
May 25, 2011

KDHE Office of Communications
communications@kdheks.gov, 785-296-0461

FDA Advisory: Use of SimplyThick for Premature Infants Linked to Necrotizing Enterocolitis

Topeka – The Kansas Department of Health and Environment would like to alert consumers that the US Food and Drug Administration (FDA) has advised parents, caregivers, and healthcare providers to not use SimplyThick, a thickening agent used for management of swallowing disorders, to infants born before 37 weeks. Use of this product may cause necrotizing enterocolitis (NEC). NEC is a life-threatening condition that can cause inflammation and death of an infant’s intestinal tissue.

As of May 20, 2011 FDA has been notified of 15 cases of NEC, including two deaths, involving premature infants who were given SimplyThick. In Kansas, KDHE has been notified of two additional cases of NEC in premature infants that were given this product. SimplyThick is mixed with mothers’ breast milk or infant formula products and 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.

Signs and symptoms of NEC include appearance of a bloated abdomen, feeding intolerance, greenish-tinged (bile) vomiting and bloody stools. Any parent or caregiver who has an infant with these symptoms should contact a healthcare provider immediately. Parents and caregivers who have questions or concerns related to the use of the product should contact a health care provider.

FDA is actively investigating the link between SimplyThick and these illnesses and deaths and will provide updates as more information becomes available. Updated information can be found at the FDA website, www.fda.gov/.