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
PY - 2024/10/18
Y1 - 2024/10/18
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.
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.
U2 - 10.1136/archdischild-2023-326580
DO - 10.1136/archdischild-2023-326580
M3 - Letter (Academic Journal)
C2 - 38123949
VL - 109
JO - ADC Fetal & Neonatal edition
JF - ADC Fetal & Neonatal edition
IS - 6
M1 - e1
ER -