FDA Warns: Do Not Use SimplyThick in Babies

SimplyThick, a product given to infants in formula to manage swallowing disorders, has been associated with a number of adverse events, including the death of at least seven babies and the need for some infants to undergo surgical procedures.

We previously wrote that the U.S. Food & Drug Administration (FDA) warned parents, caretakers, and health care providers not to use SimplyThick in feedings to premature infants born before 37 weeks. Necrotizing enterocolitis (NEC) is a life-threatening condition characterized by inflammation and death of intestinal tissue. The FDA first learned of adverse events possibly linked to SimplyThick on May 13, 2011. At that time, the agency was aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.

After receiving more adverse event reports, the agency updated its prior warning on SimplyThick, recommending against its use in all infants. Now, says The New York Times, an agency investigation into 84 cases of NEC that was published in The Journal of Pediatrics in 2012, revealed a “distinct illness pattern” in 22 cases that suggested a potential link between SimplyThick and NEC. Seven infant deaths were cited and 14 infants required surgery, the Times added. Experts are not clear on how NEC and SimplyThick are linked.

When the FDA issued its previous warning, SimplyThick was used in all neonatal intensive care units. A number of lawsuits have since been filed and the matter has raised concerns about the way in which infant food additives are followed, said the Times. Made from xanthan gum, SimplyThick is a broadly used additive that is classified as a food, is on the FDA’s list of “generally recognized as safe” substances list, and was not assessed by the agency for safety, said the Times.

Another potential issue is that some batches of SimplyThick were contaminated with dangerous bacteria. We previously wrote that Simply Thick recalled some of its thickening gel products manufactured at a Stone Mountain, Georgia food processing plant. At the time, the plant was owned and operated by Thermo Pac, LLC. SimplyThick products manufactured at two additional food processing plants were not subject to the recall.

At the time, the agency said that the SimplyThick products manufactured at the Thermo Pac, LLC Stone Mountain plant were being recalled after the FDA advised the company that Thermo Pac failed to file with it a scheduled process designed to ensure that vegetative cells (harmful bacteria) of possible public health significance are destroyed during the manufacturing process. This failure was discovered during an FDA inspection of the Thermo Pac plant conducted in 2011.

According to the Times, some babies may have ingested the potentially contaminated, recalled batches. FDA report authors theorized that the intestinal membranes of babies might have suffered damage when bacteria broke the xanthan gum down into a number of toxic byproducts, said the Times.

SimplyThick president, John Holahan, said the company marketed SimplyThick to speech language pathologists who, then, recommended the product in infant use. SimplyThick’s patent, however, touted its efficacy in collaboration with breast milk, noted the Times. Neonatal intensive care unit physicians typically ask speech therapists to determine if an infant suffers from a swallowing problem; SimplyThick is often recommended for infants with either acid reflux or swallowing problems. “There was no need to conduct studies, as the use of thickeners overall was already well established. In addition, the safety of xanthan gum was already well established,” Holahan told the Times.

Used in adults since 2001 for swallowing issues, SimplyThick produces a liquid similar in consistency to honey and enables the drinker additional time to close his/her airway and prevent aspiration, the Times explained.