Be cautious in using thickening agents for preemies
- Copyright © 2011, The American Academy of Pediatrics
Pediatricians should use caution when advising families to use thickening products containing xanthan gum or similar agents for management of swallowing disorders in infants at high risk for necrotizing enterocolitis (NEC). This includes infants born before 37 weeks’ gestation until they are at least 44 weeks postmenstrual age.
It is unknown if infants with other conditions at increased risk for NEC, including those with intestinal wall defects and congenital heart disease, also should avoid these products.
On May 20, the Food and Drug Administration (FDA) warned that use of a product called SimplyThick should be stopped immediately in hospitalized infants born before 37 weeks’ gestation and premature infants discharged from the hospital in the last 30 days (http://aapnews.aappublications.org/cgi/content/full/aapnews.20110523-1v1). This warning was based largely on reports circulated via listservs and then reported to the FDA. Approximately 15 babies were reported to have developed NEC after using this product. Two babies died after SimplyThick was mixed with breast milk or formula to help with swallowing difficulties from complications of premature birth. Several of the babies developed NEC after hospital discharge.
The FDA and product manufacturer are investigating these reports. The problem may be isolated to certain batches of a single product. However, the risk of NEC may be related to the use of thickening products in general, especially those made with xanthan gum or other thickeners such as cornstarch.
Xanthan gum is widely available in stores and on the Internet as are guidelines for mixing it into infant formula or breast milk. Parents may use these products without consulting their pediatrician, so a proactive approach to discussions with families may be advised.
This is a challenging situation for both families and pediatricians. Commercial thickeners are popular and have become widely used despite little evidence for their benefit in preterm infants. For now, pediatricians should limit their use to older and non-preterm infants and advise families that the safety and effectiveness of alternatives are uncertain. An individualized approach using paced feedings is needed, and consultation with a pediatric gastroenterologist may be advised.
The practice of thickening feeds in premature infants assumes that infants have the same oropharyngeal and digestive protective mechanisms as older infants. There also is concern that additives may further decrease motility and nutrient absorption due to the slower gastrointestinal motility of preterm infants. In addition, these additives may increase the risks associated with aspiration of the thickened feeds due to immature esophageal motility and function.
Guidelines for use of xanthan gum and other commercial thickeners may be developed as more information becomes available from the FDA and product manufacturers. For now, caution is recommended in using these products in preterm infants or other infants at high risk for NEC.
For a link to the FDA safety alert and related resources, visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm.
Dr. Abrams is a member of the AAP Committee on Nutrition.