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FDA Warnings for SimplyThick Infant Deaths

No Longer Accepting Cases

September 21, 2012 — At least 7 infants have died and 15 infants were severely injured after being fed SimplyThick. The U.S. Food and Drug Administration (FDA) is warning that infants of any age can die if they are fed this product.

Some people add SimplyThick to breast-milk or infant formula to help babies swallow food, especially if they spit up a lot. Unfortunately, SimplyThick is associated with the development of necrotizing enterocolitis (NEC) — severe inflammation of the intestines that can cause tissue death, and often requires surgery.

Experts at the FDA caution that more research must be conducted, and a causal link between SimplyThick and NEC has not been established. Caregivers for infants should talk to their doctor before feeding SimplyThick to a baby of any age, but especially premature infants and sick infants.

The FDA has been aware of this potential hazard since May 2011, when they issued a warning. The FDA had received 15 injury reports, including 2 reported deaths, of premature infants who were fed SimplyThick. At the time, the FDA cautioned against feeding SimplyThick to premature babies born before 37 weeks of gestation.

The FDA is now updating this announcement to warn that SimplyThick can cause severe injury in infants of any age. The update is in response to a study published in The Journal of Pediatrics, which described 22 cases of infants who developed NEC after being fed SimplyThick — including one full-term infant. This suggests that all infants, not just premature infants, may be at risk of this side effect. The study also reported that 14 babies required surgery to remove diseased portions of their intestines. Half of the babies developed NEC after being discharged from the hospital.

Researchers and the FDA are warning parents to watch for symptoms of NEC if they feed SimplyThick to an infant. Symptoms may include:

  • Distended abdomen
  • Greenish-tinged vomit
  • Bloated stomach
  • Diarrhea
  • Vomiting
  • Blood in stools
  • Lethargy
  • Feeding intolerance

Caregivers should contact a health care professional if a child displays any of the above-listed symptoms, or any other symptoms that cause concern.

In September 2011, the first SimplyThick lawsuit was filed by the parents of Brayden Flowers, a 17 week-old infant who fell into a coma and died after being fed SimplyThick. If your child was injured by SimplyThick, you may still have time to file a lawsuit seeking compensation and justice for your child’s injuries.

Necrotizing enterocolitis (NEC) is a severe inflammatory disease that primarily affects premature infants and sick infants, who often have under-developed digestive system when they are born. Intestinal tissue becomes inflamed and begins to die. Surgery is frequently necessary to excise diseased portions of the intestines.


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