The Food and Drug Administration is warning parents, caregivers and health care professionals 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 FDA has identified 22 infants who developed necrotizing enterocolitis—a condition in which tissue in the intestines becomes inflamed and dies—after being fed SimplyThick. Seven of those infants died.
The FDA reports that further study is needed to determine if there is an actual link between consumption of SimplyThick and necrotizing enterocolitis. Nonetheless, the FDA is now warning 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 thickening agent used to help manage swallowing difficulties. It is advertised as “the next-generation food and beverage thickener designed specifically for people who have difficulties swallowing.” According to the SimplyThick website, the product is intended to provide “a solution to the problems patients, their families and healthcare professionals raise with products currently serving the dysphagic population.”
According to Benson M. Silverman, M.D., director of FDA’s Infant Formula and Medical Foods Staff, the thickening agent is added to breast milk and infants’ formula to help 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.
The FDA reports that it first learned of 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. Later that month, the FDA advised against feeding SimplyThick to infants born before 37 weeks gestation because it could cause life-threatening injuries.
The FDA then 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 one of the babies found to develop necrotizing enterocolitis was a baby born at full term—not a premature baby. The other 21 infants, however, were born prematurely.
According to the FDA, symptoms to watch for include
- 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.
For a free legal consultation about your case, contact the lawyers at Heygood, Orr & Pearson by calling us toll-free at 1-877-446-9001, or by filling out our free case evaluation form on this website.