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FDA Warning for Simply Thick

by Sue Hubbard, M.D.

I have been receiving many questions regarding Simply Thick, a thickening agent that is used in formula to aid in swallowing and gastro-esophageal reflux.  The FDA has issued a warning against the products use after a recent investigation.

The product is often used in premature infants as they seem to have more difficulty in coordinating suck and swallow and may aspirate breast milk or formula. It also seems to help with spitting up/reflux.

Simply Thick has also been used in full term healthy infants who seem to have a problem with frequent spitting, including inability to gain weight due to their reflux, or even excessive irritability thought to be due to their spitting up and esophageal irritation.

There have been recent reports from several medical centers around the United States relating necrotizing enterocolitis and the use of Simply Thick.

Necrotizing enterocolitis (NEC) is seen more often in premature infants and causes severe inflammatory changes in the intestine, which may lead bowel perforations requiring surgery to remove the affected intestine, as well as overwhelming infection, and at times death.

The FDA is now aware of 15 cases of NEC, including two deaths, involving premies who were being fed breast milk or formula with Simply Thick added. Each of these babies had received the mixture for varying amounts of time. While NEC typically occurs early in the course of a premature baby’s life, some of these cases have even occurred after the baby had been discharged from the hospital and were at home receiving thickened feedings. At this time the link between Simply Thick and babies becoming sick is not known.

Bottom line? I would recommend to any patient, stop using Simply Thick immediately, even if your baby was not premature. Why take a risk?  We can go back to thickening feedings with rice cereal if necessary, as it was the standard before Simply Thick was introduced. A little bit messier and time consuming, but rice cereal has been used “forever” with no known problems.

That’s your daily dose for today.  We’ll chat again tomorrow.

Related Posts on www.kidsdr.com

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