September 18, 2012: The Food and Drug Administration (FDA) has released a warning to parents, caregivers and healthcare providers regarding SimplyThick gel, a thickening agent added to breast milk and formula to help premature babies swallow their food and keep it down, without spitting up.
SimplyThick was recalled in May 2011 due to the company's failure to ensure that harmful bacteria were destroyed
in the manufacturing process (read the original recall here). In the 2011 recall warning, the FDA advised parents and healthcare providers against feeding SimplyThick to infants born before 37 weeks gestation who were currently receiving hospital care or those who had been discharged from the hospital in the past 30 days because of the risk of developing a life-threatening condition known as necrotizing entercolitis (NEC).
NEC is characterized by inflammation and death of intestinal tissue and is most often diagnosed in babies who are born prematurely. Signs and symptoms of NEC include a bloated abdomin, signs of illness, feeding intolerance, greenish-tinged (bile) vomiting and bloody stools.
As more studies are conducted to determine if SimplyThick promotes NEC, the FDA released a caution to parents and healthcare providers of the potential risk of NEC in infants of any age, not just those under 37 weeks gestation as in the 2011 recall. Contact your child's healthcare provider before using SimplyThick, if you have any concerns regarding SimplyThick and be sure to report any of the following symptoms:
- Bloated stomach
- Greenish-tinged vomiting
- Bloody stools
To learn more on this recall visit the FDA's website
The recall presented here has been obtained from the U.S. Food and Drug Administration (FDA),a division of the Department Health and Human Services responsible for monitoring medications, biological products, medical devices, food, cosmetics and products that emit radiation.
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Author : Diba Tillery RN, BSN, IBCLC, CPST