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September 21, 2012 — The U.S. Food and Drug Administration (FDA) is warning that infants can die if they are fed SimplyThick, a thickening agent that is sometimes added to breast-milk or infant formula to help babies swallow their food without spitting up.

Since May 2011, the FDA has identified 22 infants who were fed SimplyThick and developed necrotizing enterocolitis (NEC), a life-threatening condition in which the intestines become inflamed and the tissue dies. At least 7 infants have died from this condition.

The FDA cautions that more research needs to be conducted, but parents and caregivers should be aware of this potential risk before feeding SimplyThick to any infant. Parents should contact their physician before feeding SimplyThick to their infant.

The FDA previously warned about the dangers of SimplyThick in May 2011. At the time, the FDA had received 15 reports of NEC, including 2 deaths, associated with SimplyThick. They warned that SimplyThick should not be fed to premature infants (born before 37 weeks gestational age). Now, the FDA is warning that infants of any age could develop NEC after being fed SimplyThick.

A study published in The Journal of Pediatrics found reports of 22 infants who developed NEC linked to SimplyThick. Of these, 21 infants were premature, but one infant was full-term. About half of these babies developed NEC after being sent home from the hospital, and 14 infants required surgery.

The researchers are cautioning that more research is needed to determine if there is a definite link between SimplyThick and NEC. However, in the meantime, infant caregivers should take precautions — including talking to a doctor before feeding SimplyThick to an infant, and watching for early symptoms of NEC.

Symptoms to watch for include:

  • Bloated stomach
  • Greenish-tinged vomit
  • Bloody stools
  • Diarrhea
  • Lethargy
  • Vomiting
  • Feeding intolerance

If a baby has any of the above-listed symptoms, or any other concerning symptoms, the FDA recommends contacting a health care professional immediately.

The first SimplyThick lawsuit has already been filed by the parents of Brayden Flowers, an infant who died after consuming the product. The lawsuit alleges that Brayden fell into a coma after being fed SimplyThick, and died at the age of 17 weeks.

Necrotizing enterocolitis (NEC) is a life-threatening disease that occurs when portions of the intestines become inflamed, and tissue begins to die. It primarily affects premature, sick infants, who are typically born with under-developed gastrointestinal system. Surgery is often necessary to remove the necrotic portion of the intestines.