3 cheers for powdered formula
http://www.suburbanchicagonews.com/beaconnews/news/1279129,aurora-baby-formula-risks-au111308.article
i was absolutely sick reading this article.
Powdered infant milk linked to deadly form of meningitis in preemies
November 13, 2008
By DAVE SAVINI AND MICHELE YOUNGERMAN | CBS2 Reporters AND CHRISTINE MOYER | Staff Writer
A warning for parents: Milk-based powdered formula could put premature babies at risk.
And it is a possible cause for the death of an infant born at Rush-Copley Medical Center in Aurora and other babies across the country.
Somonauk residents Amanda Carlin and Timothy McGray hold Kaytlyn Anne McGray (left), 3, and 1-year-old Logan Richard McGray. Logan's twin brother Connor Paul McGray died in May. His death, public health officials say, may be linked with a powdered breast milk fortifier.
(Donnell Collins/Special to Suburban Chicago News)
» Click to enlarge image
Connor Paul McGray died as an infant due to medical complications evolving from meningitis that may be linked to baby formula. Connor has a surviving twin brother named Logan and the family resides in Somonauk.
Connor McGray and his twin brother Logan were born prematurely on Nov. 16, 2007, at Rush-Copley.
Connor appeared to be the healthier of the two - until a week later when their parents, Amanda Carlin and Tim McGray of Somonauk, received a call from a doctor at the hospital, saying the infant was lethargic and refusing to eat.
Doctors discovered Connor had meningitis, McGray said, and "they basically told us, all we could do (was) pray."
The baby died at home on May 3, 2008, five months after he was born.
The cause of death listed on the baby's death certificate is 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 baby while he was being cared for in the Neo-Natal Intensive Care Unit at Rush-Copley.
In a statement released Thursday, Rush-Copley said, "We have the utmost compassion for the baby and his family.
"Rush-Copley delivers 4,000 babies a year and the procedures followed here are consistent with the standards of care provided to prematurely born infants in the U.S."
Bacteria leads to infection
The danger with powdered formula is that, unlike the liquid kind, it cannot be sterilized, making it vulnerable to bacteria growing in it, according to the Centers for Disease Control and Prevention.
The most severe cases involve babies exposed to a bacteria called Enterobacter sakazakii, or E-sak, which can lead to raging infections, severe brain damage and ultimately death, according to the CDC.
Amanda Carlin said Connor died after the E-sak bacteria led to an infection which caused the deadly form of meningitis.
The baby suffered from seizures and brain abscess. And his blood and cerebral spinal fluid tested positive for the organism, the Health Department document says.
During the week before Connor's illness, the Health Department memo says, he was fed ready-to-feed liquid formula as well as breast milk with powdered infant fortifier.
The powdered formula used by the hospital was Enfamil by Mead Johnson. Connor consumed the product from Nov. 20 through Nov. 24 orally and through a nasogastric tube, the Health Department says. The report said 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, McGray said, the family wanted the twin boys together. Logan was being treated at the University of Chicago for an intestinal condition.
Preemies at greatest risk
Infants born prematurely, or those with weak immune systems, are at greatest risk of being infected, according to the U.S. Department of Health and Human Services. 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."
Carlin 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 ahold of whatever medical records we could get," McGray said. "That's the only way we knew."
More cases
A CBS2/Suburban Chicago News investigation 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.
"It's not an isolated problem," said Ed Manzke, one of the attorneys hired in Connor McGray's case.
"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."
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."
The FDA also said there are sterilized liquid fortifiers on the market that can be used as an alternative. The FDA would not put a complete ban on the powder and said it may be used in the NICU when no appropriate liquid product is available.
Five years after this FDA warning, Connor McGray was given the powdered formula, according to the Health Department document.
His family says he was getting stronger and doing well until he got the powder.
Another case
Similar to Connor, Daniel Korte was born prematurely last year. He, too, 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."
On the market
Federal regulators believe the number of cases are under-reported. There may be other infants diagnosed with meningitis that have not been checked for E-sak.
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,'" said Meyer. "Especially if it comes in a hospital gift bag."
Manufacturers
Mead Johnson, manufacturer of powdered formula including Enfamil, 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 said.
Both manufacturers have been sued by formula victims.
The parents of Connor McGray and Daniel Korte are also 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," said Amanda Carlin.
http://www.suburbanchicagonews.com/beaconnews/news/1279129,aurora-baby-formula-risks-au111308.article
i was absolutely sick reading this article.
Powdered infant milk linked to deadly form of meningitis in preemies
November 13, 2008
By DAVE SAVINI AND MICHELE YOUNGERMAN | CBS2 Reporters AND CHRISTINE MOYER | Staff Writer
A warning for parents: Milk-based powdered formula could put premature babies at risk.
And it is a possible cause for the death of an infant born at Rush-Copley Medical Center in Aurora and other babies across the country.
Somonauk residents Amanda Carlin and Timothy McGray hold Kaytlyn Anne McGray (left), 3, and 1-year-old Logan Richard McGray. Logan's twin brother Connor Paul McGray died in May. His death, public health officials say, may be linked with a powdered breast milk fortifier.
(Donnell Collins/Special to Suburban Chicago News)
» Click to enlarge image
Connor Paul McGray died as an infant due to medical complications evolving from meningitis that may be linked to baby formula. Connor has a surviving twin brother named Logan and the family resides in Somonauk.
Connor McGray and his twin brother Logan were born prematurely on Nov. 16, 2007, at Rush-Copley.
Connor appeared to be the healthier of the two - until a week later when their parents, Amanda Carlin and Tim McGray of Somonauk, received a call from a doctor at the hospital, saying the infant was lethargic and refusing to eat.
Doctors discovered Connor had meningitis, McGray said, and "they basically told us, all we could do (was) pray."
The baby died at home on May 3, 2008, five months after he was born.
The cause of death listed on the baby's death certificate is 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 baby while he was being cared for in the Neo-Natal Intensive Care Unit at Rush-Copley.
In a statement released Thursday, Rush-Copley said, "We have the utmost compassion for the baby and his family.
"Rush-Copley delivers 4,000 babies a year and the procedures followed here are consistent with the standards of care provided to prematurely born infants in the U.S."
Bacteria leads to infection
The danger with powdered formula is that, unlike the liquid kind, it cannot be sterilized, making it vulnerable to bacteria growing in it, according to the Centers for Disease Control and Prevention.
The most severe cases involve babies exposed to a bacteria called Enterobacter sakazakii, or E-sak, which can lead to raging infections, severe brain damage and ultimately death, according to the CDC.
Amanda Carlin said Connor died after the E-sak bacteria led to an infection which caused the deadly form of meningitis.
The baby suffered from seizures and brain abscess. And his blood and cerebral spinal fluid tested positive for the organism, the Health Department document says.
During the week before Connor's illness, the Health Department memo says, he was fed ready-to-feed liquid formula as well as breast milk with powdered infant fortifier.
The powdered formula used by the hospital was Enfamil by Mead Johnson. Connor consumed the product from Nov. 20 through Nov. 24 orally and through a nasogastric tube, the Health Department says. The report said 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, McGray said, the family wanted the twin boys together. Logan was being treated at the University of Chicago for an intestinal condition.
Preemies at greatest risk
Infants born prematurely, or those with weak immune systems, are at greatest risk of being infected, according to the U.S. Department of Health and Human Services. 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."
Carlin 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 ahold of whatever medical records we could get," McGray said. "That's the only way we knew."
More cases
A CBS2/Suburban Chicago News investigation 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.
"It's not an isolated problem," said Ed Manzke, one of the attorneys hired in Connor McGray's case.
"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."
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."
The FDA also said there are sterilized liquid fortifiers on the market that can be used as an alternative. The FDA would not put a complete ban on the powder and said it may be used in the NICU when no appropriate liquid product is available.
Five years after this FDA warning, Connor McGray was given the powdered formula, according to the Health Department document.
His family says he was getting stronger and doing well until he got the powder.
Another case
Similar to Connor, Daniel Korte was born prematurely last year. He, too, 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."
On the market
Federal regulators believe the number of cases are under-reported. There may be other infants diagnosed with meningitis that have not been checked for E-sak.
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,'" said Meyer. "Especially if it comes in a hospital gift bag."
Manufacturers
Mead Johnson, manufacturer of powdered formula including Enfamil, 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 said.
Both manufacturers have been sued by formula victims.
The parents of Connor McGray and Daniel Korte are also 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," said Amanda Carlin.