Genomic sequencing matched baby's fatal sepsis case to bacteria in Evivo with MCT Oil.
A spokesperson for the company responded to CBS News, however, saying that Infinant Health is planning to continue distributing its “Evivo powder product” for consumers to buy and intends “to work with the FDA toward approval of the use of our MCT oil product in hospital settings.”
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The infant developed sepsis from the bacterium in the probiotic product—Evivo with MCT Oil made by Infinant Health—and subsequently died.
In a statement to Ars, the FDA said it quickly investigated the death after receiving an initial report on July 31.
“In September 2023, genomic sequencing data analysis performed by the FDA found that the probiotic bacteria present in Evivo with MCT Oil was a genetic match to the bacterium isolated from the infant’s blood,” the agency said.
The agency noted that the case isn’t the first of its kind; there have been previous reports of infections and sepsis in infants due to the use of probiotics containing bacteria and yeast.
“Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of <1000 g.” Still, a 2021 report found that approximately 10 percent of very premature infants in the US receive some sort of probiotic preparation while receiving specialized care in hospitals.
The agency criticized the California-based company for clearly marketing its unapproved product—sold as a dietary supplement—for use in the prevention of a serious disease in highly vulnerable pre-term infants.
I am not the brightest bulb, so I do feel bad about saying this does come down to the intersection of intelligence and common sense. Back in my day it was vitamins for kids. My mother had us taking 6 or 7 a day because that fucking doctor on Oprah said vitamins and supplements were good. There was no thought process. She just went to the store the next day and loaded up on dozens of bottles of stuff.
I would wager that in the case of this infant, a similar situation occurred. The parent outsourced their thought processing to the groupthink of a Facebook mom-group and never gave it a second thought.
Similarly, when I was young, doctors and pharmacists/chemists would tell you to never give Aspirin to babies and very young children. Did the mothers listen? They did not. Later when I worked in a pharmacy we kept all Aspirin behind the counter and specifically told them in blunt language about the risks of giving this to babies.
Anyway, this is a horrible story. Right up there with parents giving their babies almond milk and seemingly competent adults drinking colloidal silver.
The parent outsourced their thought processing to the groupthink of a Facebook mom-group and never gave it a second thought.
In my due date/birth/parenting group* , the common response to anyone mentioning that their child is plagued by gas, writhing discomfort credited to gas or constipation, or constipation, is one of two things – chiropractor or probiotics. Mind you, my child isn’t even as old as an infant, they are new born new born new born. Kids at that age just have digestive issues because it is the only body system that hasn’t been used in utero so it has to work the kinks out land-side. But given that the comments are overwhelmingly in favor of these two absolutely awful choices** because we who follow science-based parenting have fled the group to save our brain beans by not spending every hour of every day countering the essential oil mommies, I can see where a truly bewildered new parent who doesn’t know how to vet credibility might conclude that a seemingly unanimous response means it is the right thing to do.
Now, I still am struggling with how, if you’ve had a child and have a pediatrician, you might not know how to vet credibility. Seems obvious to me that the one who went to med school is credible. But the world has all kinds.
So yes, I do suspect that your reasoning is the answer.
*I don’t know what to call it. It started out as a due date bump-buddies group when I first learned I was pregnant and has evolved now that the children are born.
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🤖 I’m a bot that provides automatic summaries for articles:
Click here to see the summary
The infant developed sepsis from the bacterium in the probiotic product—Evivo with MCT Oil made by Infinant Health—and subsequently died.
In a statement to Ars, the FDA said it quickly investigated the death after receiving an initial report on July 31.
“In September 2023, genomic sequencing data analysis performed by the FDA found that the probiotic bacteria present in Evivo with MCT Oil was a genetic match to the bacterium isolated from the infant’s blood,” the agency said.
The agency noted that the case isn’t the first of its kind; there have been previous reports of infections and sepsis in infants due to the use of probiotics containing bacteria and yeast.
“Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of <1000 g.” Still, a 2021 report found that approximately 10 percent of very premature infants in the US receive some sort of probiotic preparation while receiving specialized care in hospitals.
The agency criticized the California-based company for clearly marketing its unapproved product—sold as a dietary supplement—for use in the prevention of a serious disease in highly vulnerable pre-term infants.
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good bot
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Why would anyone give a probiotic to an infant?!
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I am not the brightest bulb, so I do feel bad about saying this does come down to the intersection of intelligence and common sense. Back in my day it was vitamins for kids. My mother had us taking 6 or 7 a day because that fucking doctor on Oprah said vitamins and supplements were good. There was no thought process. She just went to the store the next day and loaded up on dozens of bottles of stuff.
I would wager that in the case of this infant, a similar situation occurred. The parent outsourced their thought processing to the groupthink of a Facebook mom-group and never gave it a second thought.
Similarly, when I was young, doctors and pharmacists/chemists would tell you to never give Aspirin to babies and very young children. Did the mothers listen? They did not. Later when I worked in a pharmacy we kept all Aspirin behind the counter and specifically told them in blunt language about the risks of giving this to babies.
Anyway, this is a horrible story. Right up there with parents giving their babies almond milk and seemingly competent adults drinking colloidal silver.
In my due date/birth/parenting group* , the common response to anyone mentioning that their child is plagued by gas, writhing discomfort credited to gas or constipation, or constipation, is one of two things – chiropractor or probiotics. Mind you, my child isn’t even as old as an infant, they are new born new born new born. Kids at that age just have digestive issues because it is the only body system that hasn’t been used in utero so it has to work the kinks out land-side. But given that the comments are overwhelmingly in favor of these two absolutely awful choices** because we who follow science-based parenting have fled the group to save our brain beans by not spending every hour of every day countering the essential oil mommies, I can see where a truly bewildered new parent who doesn’t know how to vet credibility might conclude that a seemingly unanimous response means it is the right thing to do.
Now, I still am struggling with how, if you’ve had a child and have a pediatrician, you might not know how to vet credibility. Seems obvious to me that the one who went to med school is credible. But the world has all kinds.
So yes, I do suspect that your reasoning is the answer.
*I don’t know what to call it. It started out as a due date bump-buddies group when I first learned I was pregnant and has evolved now that the children are born.
**For the lurking parents or parents-to-be who are skeptical about the claim I casually tossed out: Chiropractic at best does nothing but is a parental placebo and at worst can permanently injure the child. Nothing but milk or formula is supposed to be given to a child before 4 months of age lest there be risks of life threatening infection as seen in the parent article.