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Letter
Probiotics for preterm infants and the recent FDA alert in the USA
  1. Nicholas D Embleton1,2,
  2. Janet Berrington1,3,
  3. Paul Clarke4,5,
  4. Aniko Deierl6,
  5. Karen Luyt7,
  6. Marie Spruce8,
  7. Sam J Oddie9
  1. 1Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
  2. 2Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
  3. 3Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK
  4. 4Neonatal Intensive Care Unit, Norfolk Norwich University Hospital, Norwich, UK
  5. 5Norwich Medical School, University of East Anglia, Norwich, UK
  6. 6Neonatology, Imperial College Healthcare NHS Trust, London, UK
  7. 7Bristol Medical School, University of Bristol, Bristol, UK
  8. 8NEC-UK Charity, Nottingham, UK
  9. 9Bradford Neonatology, Bradford Royal Infirmary, West Yorkshire, UK
  1. Correspondence to Dr Nicholas D Embleton, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE1 4LP, UK; nicholas.embleton{at}ncl.ac.uk

https://doi.org/10.1136/archdischild-2023-326580

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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 …

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    Footnotes

    • Twitter @NeoResearch_Net, @neonatalbiobank, @DeierlA, @KarenLuyt

    • Contributors The letter was first drafted by NDE. All authors wrote the letter and approved the final version.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests NDE has provided advice to Neobiomics, which markets a probiotic product available in the UK and Europe, but has never received any remuneration or in-kind benefit. NDE has provided non-remunerated advice to the WHO on the design of probiotic trials in infants.

    • Provenance and peer review Not commissioned; internally peer reviewed.

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      Ashok Karupaiah Abdulhakim Abdurrazaq Josephine Quaynor Ammar Abdelhady
      Archives of Disease in Childhood - Fetal and Neonatal Edition 2023; - Published Online First: 16 Dec 2023. doi: 10.1136/archdischild-2023-326404