The Food and Drug Administration is telling parents, health care workers and people who take care of babies to avoid using a thickener for breast milk or formula fed to premature infants.
A product called may be causing life-threatening damage to children's intestines, the agency said. The FDA, which first learned about possible problems with SimplyThick on May 13, is now aware of 15 cases of necrotizing enterocolitis (NEC), including two deaths.
In all those cases, the FDA says SimplyThick gel was added to the formula or breast milk fed to the babies, who had trouble swallowing because of complications from their premature birth.
The agency said the pattern of illness from NEC seen with SimplyThick is "unusual" because it's more common among premature babies while they're still in the hospital. Some of the cases seen were in babies who had been discharged from the hospital.
Symptoms of NEC include abdominal bloating, greenish-tinged vomiting and bloody bowel movements.
The maker of SimplyThick is conducting its own investigation into the issue and said it is cooperating with the FDA.
What is SimplyThick anyway? The active ingredient is xanthan gum, a goop made by the bacterium Xanthomonas campestris, which causes black rot on vegetables such as broccoli. U.S. Department of Agriculture researchers discovered the stuff, and it found use in the 1960s as a thickener in processed foods. If you've got a bottle of salad dressing in your fridge, you'll probably find xanthan gum among the ingredients.
SimplyThick has marketed its line of patented products as a way to help people who have trouble swallowing.
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