Baby dies after being given probiotic supplement at hospital, FDA investigating
"The U.S. Food and Drug Administration is investigating the death of a preterm infant who developed sepsis and later died as the result of ingesting live bacteria, which the FDA has linked to a probiotic supplement administered during in-hospital care."
"The FDA has not approved “any probiotic product for use as a drug or biological product in infants,” the letter said, as its usage puts them at risk of “invasive, potentially fatal disease caused by the bacteria or fungi contained in probiotics."
The American Academy of Pediatrics, the nations's leading pediatricians' group, also advises against treating preterm infants with probiotics."
Should non-FDA approved treatments come with a warning/disclosure/consent form for persons undergoing them? Or is it alright to use non approved treatments, as long as a doctor thinks it's ok?
"The U.S. Food and Drug Administration is investigating the death of a preterm infant who developed sepsis and later died as the result of ingesting live bacteria, which the FDA has linked to a probiotic supplement administered during in-hospital care."
"The FDA has not approved “any probiotic product for use as a drug or biological product in infants,” the letter said, as its usage puts them at risk of “invasive, potentially fatal disease caused by the bacteria or fungi contained in probiotics."
The American Academy of Pediatrics, the nations's leading pediatricians' group, also advises against treating preterm infants with probiotics."
Should non-FDA approved treatments come with a warning/disclosure/consent form for persons undergoing them? Or is it alright to use non approved treatments, as long as a doctor thinks it's ok?
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