SimplyThick, an additive used to thicken formula and breast milk for babies, may increase the risk of infants’ developing life-threatening intestinal problems, the Food and Drug Administration warns.
SimplyThick is a brand of thickening agent sold to consumers and medical centers used to manage infants’ swallowing difficulties. It is added to breast milk and infants’ formula to help premature babies swallow food and keep it down without spitting up.
Expanding a previous safety warning, the FDA says in the latest advisory that SimplyThick should not be given to premature infants. In the last year, federal regulators have identified 22 infants who developed necrotizing enterocolitis, a condition in which the tissue of the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died, according to the FDA.
In 2011, the FDA warned against feeding SimplyThick to infants born before 37 weeks gestation. After issuing the warning, the agency conducted an extensive review of reports of health problems potentially tied to SimplyThick and found the scope of the problems was broader than recognized.
In a study published in The Journal of Pediatrics in August, FDA physicians identified nearly two dozen infants that developed necrotizing enterocolitis after ingesting SimplyThick, including one baby born at full-term. Half of the infants developed inflamed intestines in the hospital, while half developed symptoms at home after discharge from the hospital. Fourteen required surgery.
The FDA physicians who authored the articles said additional research is needed to establish if there is a link between the inflamed intestines and SimplyThick and other thickening agents.
Symptoms of harmful side-effects to watch for include:
- Bloated stomach
- Greenish-tinged vomiting
- Bloody stools.
If your infant received a formula thickener and developed complications, talk to an attorney with extensive experience helping families injured by unsafe products.
The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by unsafe products and by manufacturers that put profits ahead of safety. We have helped thousands of clients nationwide receive full and fair compensation from pharmaceutical companies and medical product manufacturers whose products cause harm. If you suspect that you or a loved one has been harmed by an unsafe drug, contact us at 314-932-3232 or use our online contact form for a free case review.