TY - JOUR
T1 - Probiotics for preterm infants and the recent FDA alert in the USA
AU - Embleton, Nicholas D.
AU - Berrington, Janet
AU - Clarke, Paul
AU - Deierl, Aniko
AU - Luyt, Karen
AU - Spruce, Marie
AU - Oddie, Sam J.
PY - 2024/11
Y1 - 2024/11
N2 - 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.
AB - 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.
KW - Gastroenterology
KW - Intensive Care Units, Neonatal
KW - Microbiology
KW - Sepsis
KW - Therapeutics
UR - http://www.scopus.com/inward/record.url?scp=85180324040&partnerID=8YFLogxK
U2 - 10.1136/archdischild-2023-326580
DO - 10.1136/archdischild-2023-326580
M3 - Letter
VL - 109
JO - Archives of Disease in Childhood-Fetal and Neonatal Edition
JF - Archives of Disease in Childhood-Fetal and Neonatal Edition
SN - 1359-2998
IS - 6
M1 - e1
ER -