FDA cautions against using SimplyThick in premature infants

June 3, 2011

The US Food and Drug Administration (FDA) is warning parents and health care providers against feeding the thickening agent SimplyThick to premature babies. The agency has received 15 reports of necrotizing enterocolitis (NEC) involving infants born before 37 weeks who ingested the product in breast milk or formula.

The US Food and Drug Administration (FDA) is warning parents and health care providers against feeding the thickening agent SimplyThick to premature babies. The agency has received 15 reports of necrotizing enterocolitis (NEC) involving infants born before 37 weeks who ingested the product in breast milk or formula.

SimplyThick added to milk helps premature babies swallow their food and keep it down without spitting up. The thickener also is used for older children and adults who are experiencing problems in swallowing liquids caused by trauma to the throat.

FDA was alerted in mid-May to serious adverse effects of SimplyThick through its MedWatch Adverse Event Reporting System. FDA followed up with the physicians who filed the reports and with a network of neonatologists. Four medical centers also reported adverse events in infants during the last 6 months.

Necrotizing enterocolitis causes inflammation and bacterial invasion of the bowel wall and can lead to necrosis of the ileum and colon in premature infants. It usually occurs while these babies are still in the hospital, but in the reported cases some of the infants became ill after they had been discharged and sent home with a feeding regimen that included SimplyThick. Two infant deaths attributed to NEC were among the 15 reported cases.

It is not known exactly what in the thickening agent is making premature infants sick, says FDA. The agency advises parents and caregivers to immediately stop using the product even if their infant does not appear to be sick and to contact their health care provider if their baby shows symptoms such as bloated stomach, green-tinged vomit, or bloody stools.

FDA is actively investigating the link between SimplyThick and the illnesses and deaths.

FDA warns not to feed SimplyThick to premature infants [consumer update]. May 20, 2011. www.fda.gov/forconsumers/consumerupdates/ucm256250.htm. Accessed June 2, 2011.