FDA Issues Warning about SimplyThick after Two Infant Deaths

FDA Issues Warning about SimplyThick after Two Infant Deaths

June 2, 2011

Reports of illness in fifteen premature infants related to the use of SimplyThick, including two babies that have died so far, has prompted a warning by the U.S. Food and Drug Administration (FDA).

“Do not feed the thickening product called SimplyThick to infants born before 37 weeks gestation because it may cause a life-threatening condition,” the FDA warns parents, caregivers and healthcare professionals.

They should immediately stop giving this product to preemies, even if the babies do not appear sick.

SimplyThick is a food and beverage thickener intended for use with children and adults who have trouble swallowing. For infants, healthcare providers or parents add SimplyThick to breast milk or formula to help the baby swallow and keep their food down.

The FDA is investigating after receiving fifteen reports of necrotizing enterocolitis (NEC) in premature babies from at least four different hospitals across the United States. In each case, SimplyThick was part of the feeding regimen.

Babies with the gastrointestinal disease necrotizing enterocolitis suffer inflammation and death of their intestinal tissue. As NEC progresses, obstructions and perforations in the intestines may place babies at risk of Peritonitis and Sepsis. Treatment of NEC involves intravenous feeding, antibiotics and surgery.

According to researchers at the University of Virginia Health System, NEC occurs in 1%-5% of premature babies admitted to the neonatal intensive care unit. Overall, about 25% of babies who develop NEC die from the disease. However, the risk of death can be as high as 66% in babies with a very low birth weight.

“This situation is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course,” the FDA said. “But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.”

SimplyThick is available without a prescription. Consumers and medical facilities across the U.S. can purchase the product from distributors, pharmacies and online. The product comes in individual packets and 64-ounce dispenser bottles.

“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,” says the SimplyThick LLC’s website. “SimplyThick is currently conducting our own investigation into those issues in cooperation with the FDA.”

The FDA says anyone caring for an infant fed SimplyThick should immediately seek medical care if noticing the following NEC symptoms:

• Bloated Stomach
• Greenish-tinged vomit
• Blood in the stool

Other symptoms of NEC can include diarrhea, feeding intolerance, lethargy and temperature instability.

“Please note: the FDA has not issued a recall notice regarding SimplyThick, it has issued a targeted advisory for infants born before 37 weeks,” the manufacturer clarified.