Probiotics Abbott to cease sale of infant probiotic products (Similac Probiotic Tri-Blend) after FDA warning (Oct 2023) FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants

[Michael Harrop]

Article https://www.reuters.com/business/healthcare-pharmaceuticals/fda-issues-warning-letter-abbott-probiotic-products-infants-2023-10-26/

FDA Warning Letters Issued to Two Companies for Illegally Selling Probiotic Products to Treat Diseases in Preterm Infants (Oct 26, 2023) https://www.fda.gov/news-events/press-announcements/fda-raises-concerns-about-probiotic-products-sold-use-hospitalized-preterm-infants

This is different from the one earlier this month regarding Evivo with MCT Oil, Infinant Health, Bifidobacterium longum subsp. infantis EVC001. https://forum.humanmicrobiome.info/threads/after-death-of-infant-fda-warns-hospitals-about-probiotics-for-prematu.172.

Related Information:

• Dear Healthcare Provider Letter: Warning Regarding Use of Probiotics in Preterm Infants
• Warning Letter: Abbott Laboratories
• Warning Letter: Infinant Health, Inc formerly Evolve Biosystems Inc.

 

[Michael Harrop]

FDA's crackdown on probiotics for infants may cost lives, physicians say (Nov 2023) https://www.beckershospitalreview.com/patient-safety-outcomes/fdas-crackdown-on-probiotics-for-infants-may-cost-lives-physicians-say.html

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.

"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.