As a food additive, SimplyThick is indicated to assist in the process of swallowing in those who exhibit a genetic predisposition for dysphagia and infants who are unable to do so on their own. Of significant concern, however, are reports by the U.S. Food and Drug Administration (FDA) cautioning the use of SimplyThick by certain populations. According to a recent FDA Consumer Update, infants who receive SimplyThick may face an increased risk of developing a life-threatening condition known as necrotizing enterocolitis (NEC).
SimplyThick has been touted as a revolutionary thickening agent in which the dysphagic population may use to assist with swallowing. Dysphagia is a condition in which an individual may not be able to swallow properly due to throat trauma or the presence of an obstruction. By thickening the consistency in food and beverages, SimplyThick aids in the natural swallowing process. However, SimplyThick is often used to help premature infants overcome swallowing difficulties as well. The thickening agent may be added to their food or formula, therefore preventing the possibility of malnourishment. 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.
Unfortunately, many people may be unaware of the dangerous side effects that coincide with the ingestion of this thickening agent. Of significant concern, however, are several reports cautioning the use of SimplyThick by certain populations. The FDA has already advised parents, caregivers and health care providers not to feed SimplyThick to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.
Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition characterized by an infection in the intestine that leads to inflammation. In many cases, the infected tissue detaches itself from the wall of the intestine. In severe cases, the symptoms can manifest themselves into a potentially fatal complication. Unfortunately, seven infants have been confirmed dead following the ingestion of SImplyThick
According to the recently released FDA Consumer Update, officials were made aware of this association on May 13, 2011. Benson M. Silverman, M.D., director of FDA’s Infant Formula and Medical Foods Staff, was alerted by two reports in FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Upon a follow-up, officials at the FDA conducted an extensive review of reports of health problems potentially tied to SimplyThick. Their findings, published recently in The Journal of Pediatrics, included the discovery that among almost two dozen infants ultimately found to develop NEC after ingesting SimplyThick.
SimplyThick lawsuits are currently evaluating the potential link between the thickening agent and the development of the following complications:
- Bloated stomach
- Vomit consisting of a greenish tinge
- Bloody stools
- Necrotizing enterocolitis (NEC)
Do I Have a SimplyThick Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in SimplyThick lawsuits. We are currently accepting new cases in all 50 states.
If you or a loved one has been injured by SimplyThick, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.