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FDA Warns Simply Thick not safe for newborns born before 37 weeks.

FDA warns that SimplyThick could cause NEC (necrotizing enterocolitis) in infants born before 37 weeks in the womb. NEC can be a terminal condition in premature newborns, and all parents, caregivers and medical professionals should be aware.  

On May 13, 201, the FDA learned of two incidents of NEC related to SimplyThick. So far, 15 cases total have been identified, and two of these were deaths. SimplyThick was mixed with mothers’ breast milk or infant formula, and fed to newborns at various times. Four different medical centers around the country have reported these types of illnesses.  These children were given SimplyThick to help with difficulty swallowing caused by complications associated with their pre-mature birth.

The product is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.

FDA Recommends: Health care providers should stop administering the product to premature infants. Parents and caregivers who have questions or concerns related to the use of the product and/or who have medical concerns should contact their health care provider. See the photographs at the link below for images of the product.

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