Probiotics for preterm infants and the recent FDA alert in the USA

Nicholas D. Embleton, Janet Berrington, Paul Clarke, Aniko Deierl, Karen Luyt, Marie Spruce, Sam J. Oddie

Research output: Contribution to journalLetterpeer-review

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The US Food and Drug Administration (FDA) recently issued a warning regarding probiotic use in preterm infants1 leading to the withdrawal of at least two products in the USA. Product withdrawal may extend to Europe, if companies become unwilling to risk legal challenges for products that may not generate significant profits. The FDA alert highlighted the risk of € invasive, potentially fatal' sepsis with probiotics, and the unregulated nature of the market. Product marketing may have implied probiotics reduce necrotising enterocolitis (NEC), when such a claim can only be made with high-quality randomised controlled trial (RCT) evidence. Despite a plethora of RCTs and meta-analyses (MAs), no RCT with NEC as a primary outcome has shown benefit, nor has any RCT been powered with NEC as the primary outcome. This is disappointing as NEC is responsible for more than 1:20 child deaths before age 10 years.2 Nevertheless, most neonatal medicine practice is based on MAs, observational studies and clinician experience rather than definitive RCTs.

Original languageEnglish
JournalArchives of Disease in Childhood - Fetal and Neonatal Edition
Early online date16 Dec 2023
Publication statusE-pub ahead of print - 16 Dec 2023


  • Gastroenterology
  • Intensive Care Units, Neonatal
  • Microbiology
  • Sepsis
  • Therapeutics

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