Concord, NH – The New Hampshire Department of Health and Human Services (DHHS) informs consumers that the Food and Drug Administration (FDA) has issued an alert not to use SimplyThick, a thickening agent for the management of swallowing disorders in preterm infants. The FDA is aware of 15 cases, including 2 deaths, of necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue, in premature infants who were fed SimplyThick for varying amounts of time.
The thickener is added to infant formula or breast milk to aid in feeding for premature infants, born before 37 weeks gestation. The product is sold in packets of individual servings or in 64-ounce dispenser bottles.
While most babies would be in the hospital if receiving this product, it is possible that a premature infant may be discharged and still on this regimen.
“This product has been distributed nationally,” said Dr. Sharon Alroy-Preis, New Hampshire State Epidemiologist, “so there is a possibility that some parents may have been advised to use this product with their babies and we want to make sure this message gets out to ensure no one else becomes ill.”
The FDA is advising that preterm infants currently under hospital care and those discharged from the hospital within the past 30 days stop using the product. FDA has sent out a public advisory recommending that parents and caregivers contact their child’s health care provider if they have any questions or concerns about using the product.
For more information, go to MedWatch safety alert, including links to the Press Release and product photos, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm256257.htm. To speak with someone at DHHS, Division of Public Health Services call 603-271-4496 (after hours 1-800-852-3345 ext.5300).