WASHINGTON The Food and Drug Administration is warning parents and health care providers to stop using the SimplyThick additive in the breast milk and formula of premature babies after the deaths of two infants who were given it.
The FDA said the product, a thickening agent that helps infants with swallowing, may cause a potentially life-threatening intestinal disorder.
The agency said it is investigating 15 cases of necrotizing enterocolitis from at least four medical centers around the country. SimplyThick is most commonly given to premature babies who still are in the hospital.
But the FDA said some of the ill babies already had been sent home on a feeding plan that included SimplyThick.
Symptoms may include a bloated abdominal area, feeding intolerance, greenish-tinged vomiting and bloody stools.