FDA's crackdown on probiotics for infants may cost lives, physicians say

Last month, the FDA warned hospitals to stop giving probiotics to preterm infants following the death of a baby that was linked to the products. Now, some physicians are concerned that a lack of access to the products will subject premature infants to a severe gut disease, The Wall Street Journal reported Nov. 16. 

In October, the FDA launched an investigation at an undisclosed hospital after the death of a baby who was given Evivo with MCT Oil, a probiotic made by Infinant Health. Genomic sequencing showed the infant died of sepsis caused by a bacterium found in the product, which has since been recalled. Abbott has also pulled its product, Similac Probiotic Tri-Blend, from the market.

Prior to the FDA's actions, about 40% of neonatal units in the U.S. used probiotics to help prevent a condition called necrotizing enterocolitis in premature infants, according to recent estimates and and estimates from neonatologists. The condition typically develops in the first few weeks of life and in some cases, can cause holes in infants' bowels, which allows bacteria to leak into other parts of the body. The probiotics are believed to help prevent the condition by creating a healthy community of microbes in the gut.

"The number of potential lives lost from doing this is, I think, huge," Keith Barrington, MD, a neonatologist in Montreal who has criticized the FDA's response in blog posts, told The Wall Street Journal. 

Probiotics are commonly marketed as foods and dietary supplements, but none are approved for preterm infant use. They contain live organisms such as bacteria or yeast, which can cause invasive and potentially fatal diseases if they are administered to preterm infants, the FDA said in its Oct. 26 warning to healthcare providers. Without rigorous testing and testing standards, agency officials say the products pose a health risk, and have asked manufacturers to conduct comprehensive studies to ensure they are effective and safe for use in premature babies, in line with the standards in place for pharmaceuticals. 

"If there was one product that was remarkably beneficial, we would hope everybody would use it," Robert Califf, MD, FDA commissioner, told the news outlet. "Let's demonstrate it, and it becomes the standard of care."

Some worry, however, about how long that process could take, as studies are costly and could take years. The American Academy of Pediatrics has previously called data on probiotics "conflicting" and does not currently recommend them for premature babies. 

Still, some physicians say the evidence in support of probiotics use in this population has been disregarded by federal regulators, citing a recently published analysis involving more than 25,000 premature infants that found the products contain multiple strains of bacteria linked to reduced deaths and cases of necrotizing enterocolitis. 

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