SimplyThick Not for Preemies

FDA says SimplyThick may cause life-threatening condition in premature babies

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Sometimes health care providers suggest premature babies be fed milk with a thickening agent, but SimplyThick should not be offered as this type of agent.

The Food and Drug Administration (FDA) has found that infants born before 37 weeks who consumed SimplyThick may have developed necrotizing enterocolitis (NEC), a potentially fatal intestinal disorder. The FDA is not sure of the cause, but is researching it now.

"Do NOT feed SimplyThick to infants born before 37 weeks."

SimplyThick is a common brand of thickening agent that people use to help manage swallowing difficulties. People of all ages use this product, but Benson M. Silverman, M.D., neonatologist and director of FDA's Infant Formula and Medical Foods Staff, warns that infants who are born before 37 weeks should not be fed SimplyThick for swallowing problems.

Reports of bad side effects began to show up on May 13, 2011. After more research, 15 cases were found that involved premature babies who were fed SimplyThick with their mother's milk or infant formula products. The infants suffered from NEC, and two deaths were reported.

NEC causes cell death in the intestines in premature or newborn babies. It usually occurs while premature babies are still in the hospital. However, the new cases show the babies developed NEC within six months after being released from the hospital. This suggested that there was something else causing the NEC and SimplyThick was the only link found.

The FDA is uncertain of why SimplyThick is causing babies to get sick and is still researching.

Karl Klontz, M.D., a medical officer in FDA's Center for Food Safety and Applied Nutrition says we shouldn't put babies at risk even if they aren't showing symptoms. Just to be on the safe side, do NOT feed your premies SimplyThick until the FDA can get to the bottom of it.

Reviewed by: 
Review Date: 
June 2, 2011
Last Updated:
June 5, 2011