Reevaluating the FDA's warning against the use of probiotics in preterm neonates: A societal statement by ESPGHAN and EFCNI

Author:

van den Akker Chris H. P.12ORCID,Embleton Nicholas D.3ORCID,Lapillonne Alexandre45ORCID,Mihatsch Walter A.678ORCID,Salvatore Silva9ORCID,Canani Roberto B.10ORCID,Dinleyici Ener C.11ORCID,Domellöf Magnus12ORCID,Guarino Alfredo13ORCID,Gutiérrez‐Castrellón Pedro14ORCID,Hojsak Iva15ORCID,Indrio Flavia16ORCID,Mosca Alexis17ORCID,Orel Rok18ORCID,van Goudoever Johannes (Hans) B.19ORCID,Weizman Zvi20ORCID,Mader Silke21ORCID,Zimmermann Luc J. I.2122ORCID,Shamir Raanan23ORCID,Vandenplas Yvan24ORCID,Szajewska Hania25ORCID

Affiliation:

1. Department of Pediatrics‐Neonatology, Amsterdam UMC University of Amsterdam Amsterdam The Netherlands

2. Amsterdam Reproduction and Development, and Amsterdam Gastroenterology Endocrinology Metabolism Research Institutes Amsterdam The Netherlands

3. Neonatal Unit, Royal Victoria Infirmary, Population Health Sciences Institute Newcastle University Newcastle upon Tyne UK

4. Department of Neonatology, APHP Necker University Hospital Paris Cite University Paris France

5. Department of Pediatrics, Children's Nutrition Research Center Baylor College of Medicine Houston Texas USA

6. Department of Pediatrics Ulm University Ulm Germany

7. Department of Health Management Neu‐Ulm University of Applied Sciences Neu‐Ulm Germany

8. Department of Pediatrics Zollernalb Klinikum Balingen Germany

9. Department of Medicine and Technological Innovation, Pediatrics, Hospital “F. Del Ponte” University of Insubria Varese Italy

10. Department of Translational Medical Science and the ImmunoNutritionLab at the Ceinge Research Center and Task Force on Microbiome Studies University of Naples Federico II Naples Italy

11. Department of Pediatrics, Faculty of Medicine Eskisehir Osmangazi University Eskisehir Turkey

12. Department of Clinical Sciences, Pediatrics Umeå University Umeå Sweden

13. Department of Translational Medical Science, Section of Pediatrics University of Naples Federico II Naples Italy

14. International Scientific Council for Probiotics, A.C. Ciudad de México (CDMX) Mexico

15. Department of Pediatrics, University of Zagreb Medical School Children's Hospital Zagreb Zagreb Croatia

16. Department of Experimental Medicine, Pediatric Section, Medical School MedTech University of Salento Lecce Italy

17. Department Pediatric Gastroenterology and Nutrition Robert‐Debré Hospital, APHP Paris France

18. Department of Gastroenterology, Hepatology and Nutrition, University Medical Center Ljubljana, University Children's Hospital Ljubljana, Medical Faculty University of Ljubljana Ljubeljana Slovenia

19. Department of Pediatrics, Amsterdam UMC, Emma Children's Hospital University of Amsterdam Amsterdam The Netherlands

20. Faculty of Health Sciences Ben‐Gurion University Beer‐Sheva Israel

21. European Foundation for the Care of Newborn Infants (EFCNI) Munich Germany

22. Department of Pediatrics, School for Oncology and Reproduction (GROW) Maastricht UMC+ Maastricht The Netherlands

23. Institute for Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center, Faculty of Medicine Tel Aviv University Tel Aviv Israel

24. Department of Pediatrics, UZ Brussel, KidZ Health Castle Vrije Universiteit Brussel (VUB) Brussels Belgium

25. Department of Pediatrics The Medical University of Warsaw Warsaw Poland

Abstract

AbstractThe recent advisory issued by the United States Food and Drug Administration, cautioning against the routine administration of probiotics in preterm neonates, has sparked a lively debate within the scientific community. This commentary presents a perspective from members of the Special Interest Group on Gut Microbiota and Modifications within the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and other authors who contributed to the ESPGHAN position paper on probiotics for preterm infants, as well as representatives from the European Foundation for the Care of Newborn Infants. We advocate for a more nuanced and supportive approach to the use of certain probiotics in this vulnerable population, balancing the demonstrated benefits and risks.

Publisher

Wiley

Reference29 articles.

1. U.S. Food and Drug Administration. Safety and availability communication and press anouncement.2023. Accessed October 27 2023.https://www.fda.gov/media/172606/download?attachment

2. https://www.fda.gov/news-events/press-announcements/fda-raises-concerns-about-probiotic-products-sold-use-hospitalized-preterm-infants

3. International Scientific Association for Probiotics and Prebiotics. Probiotic administration in preterm infants: scientific statement.2023. Accessed October 27 2023.https://isappscience.org/probiotic-administration-in-preterm-infants-scientific-statement/

4. BarringtonK.Neonatal research blog: probiotics. What now? October 6 2023. Accessed October 27 2023.https://neonatalresearch.org/2023/10/06/probiotics-what-now/

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

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