Infants of any age who are fed SimplyThick in breast milk or formula can develop a life-threatening intestinal condition called necrotizing enterocolitis (NEC). At least 20 lawsuits have already been filed on behalf of infants who were injured.
What is SimplyThick?
SimplyThick is a xanthan gum-derived thickening agent that has been sold since 2011. It is marketed toward parents, infant caregivers, and healthcare professionals to be added to breast milk and infant formula. SimplyThick helps babies swallow their food and keep it down, without spitting up. It is sold in individual packets as well as in 64-ounce dispenser bottles that can be purchased from distributors or pharmacies. It is also used in older children and adults with swallowing problems.
FDA Safety Warnings for SimplyThick
In May 2011, the U.S. Food and Drug Administration (FDA) advised against feeding SimplyThick to premature infants born before 37 weeks gestational age. At the time, they had received 15 reports of necrotizing enterocolitis (NEC), including two deaths, among premature infants who were fed SimplyThick.
After issuing that warning, the Journal of Pediatrics published a study linking SimplyThick to almost two dozen cases of NEC — including one baby who was not premature. Fourteen of the babies required surgery. In 2012, the FDA warned that SimplyThick could potentially cause NEC in infants of any age. Click here to read more.
At least 20 lawsuits have been filed on behalf of infants who developed necrotizing enterocolitis (NEC) after being given SimplyThick, including 10 wrongful death lawsuits. According to the complaints, Xantham gum is likely responsible for the infections. Plaintiffs allege that researchers have been warning about health risks since 2004, but the manufacturers of SimplyThick failed to adequately test their product, investigate its health risks, or remove it from the market.
What is Necrotizing Enterocolitis?
Necrotizing enterocolitis (NEC) is a disease that causes inflammation and death of intestinal tissue. The damage can cause a hole in the intestines that allows bacteria to leak into the abdomen and cause infection. Treatment may involve surgery, antibiotics to fight infection, feeding through an IV, and more.
- Bloated stomach
- Greenish-tinged vomiting
- Frequent vomiting
- Low energy (lethargy)
- Bloody stools
- Problems feeding