FDA: Do not feed SimplyThick to premature infants

[RainDreamer, BSN, RN]

The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.

FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers' breast milk or infant formula products.

Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of those infants who later developed NEC to help with swallowing difficulties stemming from complications of premature birth.

The current situation is unusual because NEC most often occurs in babies within the hospital early in their premature course. But among the ill babies of which FDA is aware, some had been discharged from the hospital to home on a feeding regimen that included SimplyThick and then fell ill at home.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm256253.htm?sms_ss=email&at_xt=4dda9142a9bc1f75%2C0

[TiffyRN, BSN, PhD]

This does not come as a surprise. I remember a former micro that adjusted age was something like 34-35 weeks and developed surgical NEC which seemed to come out of left field. The neo in charge felt it was possibly related to simply thick. Is the FDA advising against only simply thick or all similar gel thickeners or any thickeners at all?

[RainDreamer, BSN, RN]

Is the FDA advising against only simply thick or all similar gel thickeners or any thickeners at all?

Not sure. The only thickener that we used was SimplyThick and we only used it to thicken breast milk, since we couldn't use rice cereal.

We had a kid earlier this year that was on honey thick feeds, thickened with SimplyThick. He was discharged, was home less than a week, then NEC'd.

Scary stuff.

[NicuGal, MSN, RN]

We have sent a lot of kids home on this...guess we lucked out! But most of ours were greater than 6 months old...we always try rice cereal first when the reflux meds don't work. I'd like to see all the data on this....what corrected age were they when they went home, things like that.

[RainDreamer, BSN, RN]

We have sent a lot of kids home on this...guess we lucked out! But most of ours were greater than 6 months old...we always try rice cereal first when the reflux meds don't work. I'd like to see all the data on this....what corrected age were they when they went home, things like that.

The FDA is recommending that infants born before 37 weeks should not be fed SimplyThick. The corrected age doesn't matter.

We use rice cereal when our kids are on formula, but we can't add rice cereal to breast milk because it breaks down the properties of the milk, therefore we used SimplyThick. But, now with these recommendations if our kids are on breast milk, then they are being switched over to formula with rice cereal or they are gavage all.