Thursday, June 13, 2013

The SimplyThick Mackenna Cope Necrotizing Enterocolitis Case History

SimplyThick is Xanthan Gum

SimplyThick investigative reports: St. Louis Magazine—June 2013—"Simply Thick: A Tragedy No One Saw Coming," Courthouse News Service— June 2013—"Babies' Deaths Blamed on 'Simply Thick' "— The New York Times—February 2013— "Warning Too Late for Some Babies" provide additional information on the subject.

Xanthan gum is classified a benign substance but according to the FDA, "xanthan gum is the primary source of bacterial endotoxin." In spite of manufacturer's and FDA online warnings, SimplyThick remains a recommended infant product.

An unknown number of infants have died or were gravely injured after being prescribed SimplyThick. Mackenna Cope was one of those infants.

"Local Baby May Have Died From Formula Additive"

KKTV—May 2011—David Nancarrow
The Food and Drug Administration has the medical files of a little girl named Mackenna Cope. Her name may be added to a list of two deaths potentially linked to an additive called SimplyThick, which the FDA is telling hospitals and health-care providers not to give premature babies.

The treatment is used at Memorial Hospital as well as in hospitals across the nation and is being investigated as contributing to a deadly condition known as necrotizing enterocolitis.

The only home Mackenna Cope ever knew was the neo-natal intensive care unit. She was born early at 33-and-a-half weeks.

"I never thought, at 26, I would be burying my daughter," said Stacy Cope.

Two years after Mckenna's death, Stacy Cope took a call she never thought she'd get from the doctor who cared for her daughter at Memorial Hospital.

"The doctor said when the FDA's warning came out, the doctor said it alerted him," she said.

The FDA has issued a warning for the use of SimplyThick, an additive used in many cases, including among premature babies who have trouble swallowing, or keeping down food. The product is now under investigation for possibly causing the type of intestinal failure that killed Mackenna a week before she could have gone home.

"At five o'clock that evening she'd been rushed in for emergency surgery, but her intestines were already dead,” Stacy said. “There was nothing they could do."
Two years has brought some peace to Stacy and her family, who originally thought they'd never know what, exactly, caused Mackenna to get so sick.

"Now to know it may be because of something someone put in her bottles is kind of unnerving," Stacy said.

Her thoughts now are for every other parent of a premature baby.

"Make sure you're aware what people are giving your children," she said.

The FDA has not determined what specifically in SimplyThick could be causing the deadly condition.

FDA officials urge care givers to not give SimplyThick to premature babies. Symptoms necrotizing enterocolitis include bloating, as well as greenish tinged bile and vomiting. Parents who have questions or concerns about the product should call their healthcare providers.
11 News has learned Memorial Hospital has referred four cases to the FDA. Parkview Medical Center in Pueblo tells 11 News that they have never used SimplyThick. A spokeswoman with the hospital said that they use rice cereal, because "it's always need to change."

11 News has placed a call with Penrose; the hospital is now looking into whether any cases involving SimplyThick have been reported.

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