FDA Warning: Do not feed the thickening product called SimplyThick to infants born before 37 weeks, because it may cause a life-threatening condition. This advice comes from both the FDA and the product’s manufacturer. The FDA has NOT issued a warning for children older than 37 weeks who are using this product.
Multiple medical centers in the U.S. have reported several illnesses and a few deaths in certain infants who were using this product. These infants suffered from a condition known as necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and dies. The FDA does not know what in SimplyThick may be making these babies sick, but it is actively investigating this link.
The FDA advises:
Parents and caregivers should not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.
Parents and caregivers should watch for symptoms – bloated stomach, greenish-tinge vomiting, and bloody stool – and report them and other concerns to their physicians or health care providers.
Parents or health care providers can report side effects to the FDA by visitingwww.fda.gov/MedWatch/report.htm or calling 1-800-332-1088 for a postage-paid form that can be faxed or mailed.
Memorial Health System is following the same FDA warning and guidelines.