FDA Cautions: SimplyThick May Cause Infant Illness and Death

As California defective drug lawyers, we closely follow The Food and Drug Administration’s (FDA) warnings and updates for adults and children with regard to medications and medical devices. The FDA has just issued a caution about a medication called SimplyThick that they say may cause injury and death to newborns and infants.

Specifically, the concern with this medication is the potential effect it has on the intestinal tissues of infants. An earlier warning had narrowed the concern to the use of the drug with premature babies, but it is now thought to be a concern for infants of any age.

The condition that can develop from the use of SimplyThick is called necrotizing enterocolitis (NEC). Premature babies and infants who have taken this have developed inflammation and the dying off of intestinal tissues. This can lead to injury and death and it is suspected that there is a link between infant illness and deaths and SimplyThick.

The use of this medication is intended to assist in swallowing. SimplyThick is used as a thickening agent for breast milk and infant formula and is sold to both health facilities and the public. It is intended to help premature babies with swallowing and is also used in older kids and adults.

The Journal of Pediatrics just published findings that expanded the concern to infants in general. Parents are asked to seek their physicians advise before using this drug for premature babies or infants. More study is underway on this situation.

The FDA has published a list of symptoms that should be a warning to parents or caregivers using this medication. They include: “bloated stomach, greenish-tinged vomiting and bloody stools.”

We will keep readers apprised of further developments about SimplyThick.

With decades of experience protecting infants and children, the lawyers of Hersh and Hersh are here to help. If you have any questions or concerns about a drug, crib or toy that may have injured your baby or infant, please contact us for a free evaluation of your situation and potential case.