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FDA Expands Caution About SimplyThick

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The Food and Drug Administration (FDA) wants parents, caregivers and health care professionals to be aware that infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick.

Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died.

Further study is needed to determine if there is an actual link between consumption of SimplyThick and the development of NEC. But, FDA wants everyone involved in the care of a baby to be aware of the potential risk before deciding whether to feed SimplyThick to infants of any age.

SimplyThick is a brand of thickening agent—available to consumers and medical centers—used to help manage swallowing difficulties. It is sold in individual serving packets as well as in 64-ounce dispenser bottles, which 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 breast milk and 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.

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The Problem

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 Safety Information and Adverse Event Reporting Program. He followed up with the physicians who filed those reports and later with a network of other neonatologists, doctors who treat newborns in need of special care. 

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

In May 2011, FDA advised against feeding SimplyThick to infants born before 37 weeks gestation because it could cause NEC. (Gestational, or post-menstrual, age is calculated from the first day of the last menstrual period, which is about two weeks before ovulation.) 

After issuing that warning, FDA conducted an extensive review of reports of health problems potentially tied to SimplyThick. Its findings, published recently in The Journal of Pediatrics, included the discovery that among almost two dozen infants ultimately found to develop NEC after ingesting SimplyThick was a baby born at full term—not a premature baby. The other 21 infants, however, were born prematurely.

The infants ranged from about 24 to 48 weeks post-menstrual age when they became sick. (An infant who is 24 weeks post-menstrual age is about four months premature.) 

Half of the infants developed NEC in the hospital, while half developed the condition at home following discharge from the hospital. Fourteen required surgery.

Silverman and Klontz are among the authors of the report that concluded that further study is warranted to establish if there is a link between NEC and SimplyThick and other thickening agents. In the meantime, says Klontz, parents should contact their child's health care provider before using SimplyThick.

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Symptoms to Watch for

  • bloated stomach
  • greenish-tinged vomiting
  • bloody stools

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 by:

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Updated Sept. 18, 2012

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