SimplyThick a risk to all infants, FDA cautions
(CNN) -- A product used to help infants with difficulty swallowing could increase their risk of developing a life-threatening illness, the Food and Drug Administration warned Tuesday.
The agency says 22 infants developed necrotizing enterocolitis (NEC) after being fed the thickening agent SimplyThick -- reportedly as directed. Seven of them died. Necrotizing enterocolitis is a condition where tissue in the intestines gets inflamed and dies. It occurs most often in babies that are ill or born prematurely. The cause is unknown.
SimplyThick is mixed with breast milk or infant formula to help babies swallow their food and keep it down without spitting it back up. It's sold in individual packets or 64-ounce bottles that can be bought from local pharmacies or distributors across the country.
Of the 22 infants who became ill, 21 were born premature. Half of the babies developed NEC while still in the hospital and the other half at home. Fourteen of them needed surgery. NEC symptoms include a bloated stomach, greenish-colored vomiting and bloody stools.
Last May, the FDA issued an advisory warning consumers of SimplyThick's risk to premature infants. The agency is now extending that warning to all babies because it believes parents, caregivers and doctors will benefit from the information if considering whether to give the thickener to babies of any age, says FDA spokeswoman Tamara Ward.
Parents and caregivers who have questions or concerns related to the use of the product or medical concerns should contact their doctor, Ward says.
The agency was first alerted to the problem when two reports were filed with its MedWatch Safety Information and Adverse Event Reporting Program. Officials say more study is needed to determine if there is an actual link between NEC and SimplyThick or other thickening agents. In the meantime, they say consumers and health care professionals need to be aware of the possible risks before using the product.
SimplyThick says consumers and doctors should follow the FDA recommendations that "anyone involved in the care of a baby be aware of potential risk before deciding whether to feed SimplyThick to infants of any age."
"If you are currently giving SimplyThick to your infant, please consult your child's health care professional," said John Holahan, CEO of SimplyThick. "We continue to advise following FDA's previous recommendation that SimplyThick brand thickener not be used with or given to babies who were born before 37 weeks. We hope that this does not cause any inconvenience to medical professionals or our customers but, as you can understand, SimplyThick wants to proceed with all due caution."
The FDA says that this product is also used for older children and adults with swallowing problems. These patients are not included in the warning.