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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 …
Footnotes
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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.