Posted by Hilary Parker on July 1, 2011
A major new recall threatens the very tiniest of babies: Those born prematurely. Make sure you read this if you’re expecting or if you know anyone who is — you could just save a life.
The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) are investigating a potential link between the thickener SimplyThick and necrotizing enterocolitis (NEC) in premature infants.
Medical professionals add SimplyThick to breast milk and infant formula to help premature babies swallow their food and keep it down, FDA officials say. In addition, the thickener is used in older children and adults who have trouble swallowing due to throat trauma.
But the current risk is to premature babies. CDC and FDA are investigating a connection between the thickening gel and NEC, a condition in which tissue in the intestines becomes inflamed and dies.
The company behind the product, SimplyThick LLC, has voluntarily recalled the thickener that was made at its Stone Mountain, Ga., plant, but thickening gel made at other SimplyThick plants remains on the market. The company says that during an FDA inspection of its Stone Mountain plant conducted May 23-June 3, it was revealed that the owners of the plant, Thermo Pac LLC, had failed to file a scheduled process designed to ensure that harmful bacteria “of possible public health significance” get destroyed while processing SimplyThick.
A paperwork snafu? Maybe. But then an uptick in NEC cases began. FDA says 15 cases of NEC have been reported — including two deaths — that involved premature infants whose food was treated with SimplyThick. What’s more, NEC typically only occurs in babies while they are very newly born and still in the hospital. But the recent NEC cases were seen in babies after they were sent home from the hospital but still using SimplyThick.
Of course, the FDA remains circumspect.
“At this time, there is not a confirmed link between SimplyThick and NEC in premature infants, though the investigation continues,” officials say in the recall alert.?”It is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.”
Symptoms of NEC include bloated stomach, greenish-tinged vomiting and bloody stools. Parents are encouraged to report any concerns to their child’s doctor at once.