FDA Warns Not to Use SimplyThick in Milk/Formula with Premature Babies

The FDA recently announced in late May that 15 infants who had been given the product SimplyThick developed a life-threatening intestinal condition known as necrotizing enterocolitis (NEC), and that two have died. This has led the FDA to warn all parents, caregivers, and health care providers NOT to use SimplyThick to help with swallowing problems in babies who were born prematurely. Nearly all of the 15 infants who developed the condition had been born prematurely (before 37 weeks) but had been released by the hospital with a diet regimen that included SimplyThick to be mixed with their milk or formula in order to thicken it so that the babies would be able to keep their liquids down.

Contained within the thickener is a cornstarch-like substance called xanthan gum, used in salad dressings and dairy products. With babies born prematurely, it is mixed in milk or formula to help with swallowing problems they may have. Essentially, it aids the baby from throwing up the liquid.

Necrotizing enterocolitis (NEC) causes severe inflammatory changes in the intestine, which may lead bowel perforations requiring surgery to remove the affected intestine, as well as overwhelming infection, and at times death. Most often it is diagnosed in babies who are born prematurely and are still in the hospital. However, most of the reports received by the FDA were among infants who had been discharged already. Symptoms of the disorder include the appearance of a bloated abdominal area, the appearance of illness, feeding intolerance, greenish-tinged vomiting and bloody stools.

If your child or the child of a loved one has developed necrotizing enterocolitis after using SimplyThick, please contact Pogust Braslow & Millrood for a free consultation to make sure that your rights are protected.