Do not feed the thickening product called SimplyThick to infants born before 37 weeks because it may cause a life-threatening condition.

This advice to parents, caregivers, and health care providers from the Food and Drug Administration (FDA) is based on reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and dies.

SimplyThick is a brand of thickening agent-available to consumers and medical centers-to help manage swallowing difficulties. It is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.

Benson M. Silverman, M.D., director of FDA's Infant Formula and Medical Foods Staff-himself a neonatologist-explains that the thickening agent is added to infants' formula to help the premature babies swallow their food and keep it down, without spitting up. The product is also used in older children and adults with swallowing problems caused by trauma to the throat, he notes.

FDA first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. Silverman says he was alerted by two reports in FDA's MedWatch Adverse Event Reporting system. He followed up with the physicians who filed those reports and subsequently with a network of other neonatologists.

Karl Klontz, M.D., a medical officer in FDA's Center for Food Safety and Applied Nutrition, says the severity and scope of the problem soon became apparent. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick mixed with mothers' breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.

At least four different medical centers around the U.S. have reported the illness in infants who became sick over the past six months.

This situation is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.

At this time it is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.

In the meantime, adds Klontz, parents should stop using the product even if their babies don't appear to be sick. "Why take the risk?" he asks.

Advice for Parents and Caregivers

Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.
Contact your health care professional if your baby has any of the symptoms listed above or if you have other concerns related to using SimplyThick.
You or your health care professional may report side effects related to using SimplyThick to FDA's MedWatch Safety Information and Adverse Event Reporting Program by:
Completing and submitting the report online: www.fda.gov/MedWatch/report.htm;
Downloading the pre-addressed, postage-paid FDA Form 3500 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or
Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857.

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