SimplyThick Risky for Babies

FDA warning about SimplyThick expanded to include all babies

(RxWiki News) Warnings about the use of a product called SimplyThick for children have been expanded by the FDA. Parents should talk to a doctor before giving it to infants.

SimplyThick is a thickening product added to baby formula or breast milk to help babies swallow food better without spitting up. It has commonly been given to premature babies.

However, SimplyThick has been linked to a dangerous condition in babies called necrotizing enterocolitis that can be fatal.

"Talk to a doctor before using SimplyThick."

Necrotizing enterocolitis occurs when the tissue of the intestines experiences inflammation and dies.

The U.S. Food and Drug Administration already issued a warning about SimplyThick in May, 2011, but that warning was limited to feeding it to babies who were born before 37 weeks of pregnancy.

It has been expanded following a review of cases conducted by Jennifer Beal, MPH,

Since May, 2011, the FDA has been notified of 22 cases in which babies who had been fed SimplyThick developed necrotizing enterocolitis. All the babies had been fed the product as directed, mixed with either breast milk or formula.

Seven of those children died, and 14 required surgery. Only one of the 22 cases involved a baby born at full term. The others were preemies.

Half of the babies developed necrotizing enterocolitis at the hospital, and half developed it at home after they had been discharged from the hospital.

The FDA does not know for certain at this time that SimplyThick caused the necrotizing enterocolitis.

However, all of the babies who developed it had been fed SimplyThick, so the FDA is warning consumers that babies who eat the product may be at a higher risk for developing the condition.

Symptoms of necrotizing enterocolitis include a bloated stomach, vomit with a greenish color to it and bloody stools (poop). If your child has any of these symptoms, seek medical care immediately.

The study of the 22 infants who developed necrotizing enterocolitis was published May 11 in The Journal of Pediatrics. The FDA updated its alert on September 18.

Review Date: 
September 22, 2012