Infant Formula Notification


Every week I get news stories that are gathered from Google searches on prematurity. This morning I was looking though the stories and found a series of alarming stories on the use of Enfamil powdered breast milk fortifier

Formula For Tragedy: Milk-Based Powdered Formula



Powdered Baby Formula Could Be Dangerous For Some Infants


CHICAGO (CBS News) ―

Connor McGray and his twin brother, Logan, were born prematurely on Nov. 16, 2007 at an Illinois hospital.

Connor
appeared to be the healthier of the two. It wasn't until their parents,
Amanda Carlin and Tim McGray of Somonauk, Ill., received a call from a
doctor at the hospital a week later saying the infant was lethargic and
refusing to eat.

Doctors discovered Connor had meningitis and "they basically told us, all we could do was pray," their parents recall.

On May 3, 2008, their baby died at home.

"He knows there's something missing," Amanda Carlin says of their surviving child, Logan, who turned 1 last week.

Officials
listed the cause of death as hydrocephalus and bacterial meningitis.
The bacterial infection, according to a memo from the Illinois
Department of Public Health, "may be associated with the consumption of
a powdered breast milk fortifier."





The Enfamil brand powdered
formula was fed to the Connor during his time in the the Neo-Natal
Intensive Care Unit at Rush-Copley Medical Center.

In a statement released on Nov. 13, 2008, Rush-Copley said: "We have the utmost compassion for the baby and his family."

Hospital
officials noted 4,000 babies are born at the facility each year and
"the procedures followed here are consistent with the standards of care
provided to prematurely born infants in the U.S."

"There was nothing I could do. I felt helpless and part of me was gone forever," Carlin said.

During
an investigation by the CBS station in Chicago, research found Connor's
death was not the only associated with the tainted baby formula claim.

The
Centers for Disease Control and Prevention says the danger with
powdered formula is that -- unlike the liquid kind -- it cannot be
sterilized, which makes it vulnerable to bacteria growing in it, CBS
station KTVT-TV reported.

The most severe cases involve babies
exposed to a bacteria called Enterobacter sakazakii, or E-sak. The CDC
notes e-sak can lead to raging infections, severe brain damage and
ultimately death, as in Connor McGray's case.

The baby
suffered from seizures and brain abscess. According to official health
records, his blood and cerebral spinal fluid tested positive for the
organism.

Premature Infants or those with weak immune systems
are at greatest risk of getting infections, the U.S. Department of
Health and Human Services reports.

There is even a warning on
powdered formula containers. One brand warns: "... powdered infant
formulas are not sterile and should not be fed to premature infants or
infants who might have immune problems unless directed and supervised
by your baby's doctor."

During the week before Connor's
illness, a health department memo notes he was fed ready-to-feed liquid
formula, as well as, breast milk with powdered infant fortifier.

Hospital records show the powdered formula the hospital used was Enfamil by Mead Johnson.

From Nov. 20 to Nov. 24, Connor was fed the product orally and through a nasogastric tube.

The
same health department report noted the product was prepared at the
hospital in a prep area/station, not a dedicated formula preparation
room.

On Dec. 3, 2007, Connor was transferred from Rush-Copley
to the University of Chicago because, Tim McGray said, the family
wanted the twin boys together. Logan was being treated at the
University of Chicago for an intestinal condition.

His mother said the hospital did not tell her about the risks of powdered formula.

She said she also didn't learn about her son being given the powder, until she hired The Collins Law firm in Naperville.

"We
didn't find out until afterward, when we got a hold of whatever medical
records we could get," McGray adds. "That's the only way we knew."

The
CBS2 investigation also uncovered other cases in which powdered formula
was blamed for causing brain damage or death in infants. There have
been at least two Illinois cases and cases in at least 17 other states,
including Texas.

Ed Manzke, one of the attorneys hired in Connor McGray's case said it's not an isolated problem.

"There
have been deaths all across the country related to powder infant
formulas. And what is so shocking about it, is hardly anyone knows it.
It's like leaving a loaded gun in a nursery."

A 2001 E-Sak outbreak in Tennessee led to a 2002 U.S. Food and Drug Administration warning to health professionals.

In
a letter the FDA wrote: "FDA recommends that powdered infant formulas
not be used in neonatal intensive care settings unless there is no
alternative available."

FDA officials also said there are sterilized liquid fortifiers on the market that can be used as an alternative.

The
FDA stopped short of issuing a complete ban on the powder, but said it
may be used in the NICU when no appropriate liquid product is
available.

Despite the warning, five years later Connor McGray
was given the powdered formula. His family says he was getting stronger
and doing well until he got the powder.

Daniel Korte also was
fed powdered infant formula and was struck with the same infection and
meningitis. His parents said the contaminated formula was fed to him at
Mercy Medical Center in Des Moines, Iowa.

Daniel survived, but is living in a nursing facility on a ventilator.

"It
basically turned his brain to mush," said Michelle Korte, Daniel's
mother. "He is ventilated and his upper brain is destroyed."

Korte said the hospital in this case also never warned her about the risk associated with the formula.

An
attorney she hired, Andy Weisbecker, said powdered formula
manufacturers need to do a better job of informing doctors and parents
about the danger.

"More needs to be done to increase the level
of knowledge about this deadly bug," Weisbecker said. "Who knows how
many parents are out there with affected children who may still not be
aware of a possible connection between these illnesses and contaminated
formula."

Federal regulators believe the number of cases are
underreported. There may be other infants diagnosed with meningitis
that have not been checked for E-sak.

"They pretty much just
want to sweep it under the rug and it's not an issue you can just sweep
under the rug. I mean it took a baby's life," Copley stresses.

Babies
are not just being sickened by formula in hospitals, however. Parents
unknowingly are buying the powdered formula for at-risk babies.

Stephen
Meyer, an attorney at the Law Office of Nick Stein in Indiana, has
spent nine years working on E-sak cases. He said the FDA's warning
should have gone to consumers.

"Most moms would think 'If it's marketed to me, it's safe' … especially if it comes in a hospital gift bag."

Mead Johnson officials said its products are safe as long as they are used according to label directions.

The
company said it has "taken the position that powdered infant formula
should not be used in neonatal intensive care settings unless no
alternative is available."

Tracey Noe, a spokesman for Abbott, which manufactures formula including Similac, said it uses rigorous testing procedures, including bacterial testing, on its powdered formulas.

"Abbott
agrees with the U.S. Food and Drug Administration/Centers for Disease
Control and Prevention joint recommendation that powdered formula
should not be used in hospital neonatal intensive care units — unless
no nutritionally suitable alternative is available," Noe responded.

Both manufacturers have been sued by families who say they were affected by the tainted formula.

The
parents of Connor McGray and Daniel Korte also are planning to file
lawsuits. In the meantime, they are talking about what happened in
hopes of warning — and educating — doctors, hospital staff and other
parents about the potential danger of powdered formula.

"I want other people to be aware of it so they don't have to go through what I did," Amanda Carlin said.


 

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