Federal food safety officials are warning parents and caregivers not to feed premature infants SimplyThick, a thickening agent used to treat swallowing disorders, after reports that infants have died due to bowel problems believed to have been caused by side effects of the solution.
On May 20, the FDA issued a SimplyThick public health warning following 15 cases of necrotizing enterocolitis (NEC) in premature infants who were fed it, including at least two deaths. The FDA said the thickening agent should not be given to any infants who were born before 37 weeks of gestation.
SimplyThick is a thickening agent used by both children and adults. When given to infants it is added to their formula or milk to help them keep food down without spitting up. It is distributed by SimplyThick, LLC and has been on the market since 2001.
FDA officials said they were first made aware of the potential risk of bowel problems from SimplyThick after reports were submitted by doctors to the FDA’s Adverse Event Reporting System (AERS) on May 13. At least four different medical centers have had infants contract necrotizing enterocolitis from SimplyThick.
However, FDA officials indicate that they are unable to determine, so far, why SimplyThick side effects would cause necrotizing enterocolitis in premature infants. The condition usually affects infants very early, but those that appear to be related to SimplyThick had a late onset, with some not being affected until they had been released from the hospital.
Necrotizing enterocolitis is an intestinal disorder that results in inflammation and necrosis of intestinal tissues. It is usually diagnosed in premature babies and can be life-threatening. Symptoms can include a bloated abdominal area, green-tinged vomiting and blood stools.
The FDA is currently investigating the link between SimplyThick and the bowel problems for infants, and will provide updates when more information is available, according to the public health warning. In the interim, parents, doctors and care givers are urged not to give SimplyThick to premature infants. Parents or care givers who have been giving an infant SimplyThick should contact a health care professional if the baby begins to show any signs of NEC.