If you are a parent and currently have or have had an infant that suffered from acid reflux you know all too well the frustration involved with keeping your baby’s milk down, as the most common symptom of acid reflux is spitting up. Some of the advice you may be given is to thicken your baby’s breast milk or formula, by adding rice cereal, etc. And, even though adding rice cereal isn’t recommended by most professionals, one company, Simply Thick LLC, has an alternative that you may desire to try; but the FDA is warning consumers to stay away from it, as acid reflux could be the least of your worries if you use this product!
The FDA has just announced that Simply Thick, a product given to infants who have difficulty swallowing their food and keeping it down, may increase their risk of developing a life-threatening illnes.
According to the agency, since May 2011, 22 infants developed necrotizing enterocolitis (NEC) after being fed baby formula or breast milk mixed with Simply Thick. 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. Seven of them unfortunately died.
NEC is a disease that causes severe inflammatory changes in the intestine. It most often strikes infants born prematurely, and all but one of the babies who fell ill after being fed Simply Thick were premature. But the FDA warned that any infant given Simply Thick was at risk. It extended previous warnings to include all babies because it believes parents, caregivers and doctors should consider this information before giving the thickener to babies of any age. Previously, the agency warned against giving Simply Thick to infants born before 37 weeks.
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.
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.
So what does this mean for parents who have given their child Simply Thick?
Dr. Ari Brown, a pediatrician in Austin, Texas, and co-author of Baby 411 said that if you’re currently using the product to thicken your baby’s breast milk or formula, discontinue use immediately and call your pediatrician. Be on the lookout for NEC symptoms, which include a bloated stomach, greenish vomit, bloody stools and lack of interest in feeding.
“If you’ve already stopped using the product for a while and your baby seems fine, there’s no need to worry,” Brown said.
Brown said that if reflux and spitting up continues to be an issue, parents do have other options. “They can try doing smaller, more frequent feedings; keeping infants upright for at least 20 minutes after eating; and placing them at a 30 percent incline for sleeping,” she said. “In severe cases, your pediatrician may prescribe medication to help treat.”
Formula-fed babies may find some relief with products that have rice starch added to their recipe. But adding rice cereal to breast milk won’t work because it breaks down and thins out too quickly, Brown said.
The agency says that further study is needed to determine whether there is an actual association between use of the thickening agent and enterocolitis, but at this point the link is unclear.