- Copyright © 2012, The American Academy of Pediatrics
A thickening product used in formula and breastmilk that was found to cause problems in some preterm infants with swallowing problems is now linked to possible necrotizing enterocolitis (NEC) in infants of any age, according to a Food and Drug Administration (FDA) advisory.
In May 2011, AAP News reported on an FDA advisory warning against feeding SimplyThick to infants born before 37 weeks’ gestation because it could cause NEC (http://aapnews.aappublications.org/content/early/2011/05/24/aapnews.20110523-1.full). One case of NEC in a baby born at full term has since been reported. To date, 22 cases have been reported in which infants have developed NEC after being fed SimplyThick. Seven infants have died.
Further investigation is necessary to determine whether there is an actual link between the consumption of SimplyThick and the development of NEC, according to the FDA. Caution also has been advised in the use of thickening products that use xanthan gum or similar agents in any infant with conditions such as intestinal wall defects and congenital heart disease, according to a July 2011 AAP News article (http://aapnews.aappublications.org/content/32/7/23.full).
If the thickening agent is used, health care clinicians and caregivers are advised to watch for symptoms, including: bloated stomach, greenish-tinged vomiting and bloody stools.
Report adverse events associated with SimplyThick to FDA’s MedWatch online at www.fda.gov/MedWatch/report.htm; download the preaddressed, postage-paid FDA Form 35006 and fax to 800-332-0178; or mailing the form to MedWatch, 5600 Fishers Lane, Rockville, MD 20857.
Review the FDA advisory at www.fda.gov/ForConsumers/ConsumerUpdates/ucm256250.htm.