The FDA is warning parents and healthcare providers alike to avoid feeding SimplyThick to infants who were born before 37 weeks gestation as it can cause a life-threatening intestinal disorder
The advice is based on reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and dies.
FDA investigating 15 cases
To date, 15 cases of NEC have been reported, including 2 deaths involving premature infants who were fed SimplyThick mixed with mothers’ breast milk or infant formula. The mixture was fed to infants for varying amounts of time.
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At least 4 different medical centers around the U.S. have reported the illness in infants who became sick over the past 6 months. Health Canada is also asking parents to stop using SimplyThick.
In a statement on its website, the company that manufactures SimplyThick said: “SimplyThick is aware of communications from certain neonatal intensive care unit physicians and staff members questioning a potential relationship between the use of Simply Thick with infants born before 37 weeks and late onset necrotizing enterocolitis. Simply Thick is currently conducting our own investigation into those issues in cooperation with the FDA.”
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SimplyThick is a thickening agent used by parents and medical centers to help babies with feeding problems. It’s sold in individual packets and 64-oz. bottles throughout the US. Symptoms parents should watch for include a bloated stomach, feeding avoidance, greenish-tinged vomiting and bloody stools.
Neonatologist Benson M. Silverman, MD, director of FDA’s Infant Formula and Medical Foods, says the thickening agent is added to formula or breastmilk to help premature babies swallow food and keep it down without spitting up.
NEC most often occurs in babies while they’re in the hospital early in their premature course. But some of the ill babies that got sick on a feeding regimen that included SimplyThick after they had been discharged from the hospital and sent home.
It’s not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths. In the meantime, the agency says parents should stop using the product.
Call your pediatrician if you see any of the following with your infant and you’ve been feeding SimplyThick:
- bloated stomach
- greenish-tinged vomiting
- bloody stools
Don’t feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days. Contact your health care professional if your baby has any of the symptoms associated with NEC or if you have other concerns related to SimplyThick.
Report any side effects related to using SimplyThick to FDA’s MedWatch Safety Information and Adverse Event Reporting Program by:
- Reporting online at www.fda.gov/MedWatch/report.htm
- Calling 800-FDA-0178 to get a pre-addressed, postage-paid FDA Form 3500
- Mailing a completed FDA Form 3500 to MedWatch 5600 Fishers Lane, Rockville, MD 20857
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