SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition
Audience: Consumers, Pediatrics, Emergency medicine
[Updated 09/18/2012] FDA issued an advisory in May 2011 that warned of the risk to infants born prematurely. FDA is now extending that advice to include infants of any age.
[Updated 06/05/2011] Simply Thick, LLC is announcing a voluntary recall of its SimplyThick thickening gel products manufactured at a food processing plant owned and operated by Thermo Pac, LLC. This voluntary recall is limited to only those products manufactured at the Stone Mountain, Georgia plant. The SimplyThick thickening gel products manufactured at the Thermo Pac, LLC Stone Mountain plant are being recalled because FDA advised the company that Thermo Pac, LLC failed to file with the FDA a scheduled process designed to ensure that vegetative cells (harmful bacteria) of possible public health significance are destroyed during the manufacturing process. See the company press release for additional information.
ISSUE: FDA notified parents, caregivers and health care providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks gestation. The 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. To date, 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 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. See the photographs at the link below for images of the product.