Scholarlink

<p>Necrotizing enterocolitis (NEC) is a severe gastrointestinal emergency in preterm infants, leading to high mortality and long-term complications. Probiotics have been extensively studied and shown in multiple randomized trials and meta-analyses to significantly reduce the incidence of severe NEC, all-cause mortality, and late-onset sepsis. Despite strong evidence and international guidelines supporting their use, probiotic administration in US neonatal intensive care units has sharply declined following a 2023 FDA advisory. The FDA cited safety concerns, lack of product quality control, and the unapproved drug status of probiotics as reasons for this warning. This paper reviews the compelling evidence for probiotic efficacy, examines the FDA’s rationale, and contrasts US policy with global practices. It highlights the risk-benefit imbalance of withholding probiotics, analyzes the resulting clinical dilemma, and proposes a path forward through regulatory reform, ongoing research, and stakeholder collaboration to ensure access to this potentially life-saving intervention for preterm infants.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Navigating the United States FDA advisory: Probiotics in Preterm Infants

  • 期刊论文

  • 发表日期：

    2026年2月3日

查看全文
  • Sreekanth Viswanathan,
  • Kanekal Suresh Gautham

摘要

Necrotizing enterocolitis (NEC) is a severe gastrointestinal emergency in preterm infants, leading to high mortality and long-term complications. Probiotics have been extensively studied and shown in multiple randomized trials and meta-analyses to significantly reduce the incidence of severe NEC, all-cause mortality, and late-onset sepsis. Despite strong evidence and international guidelines supporting their use, probiotic administration in US neonatal intensive care units has sharply declined following a 2023 FDA advisory. The FDA cited safety concerns, lack of product quality control, and the unapproved drug status of probiotics as reasons for this warning. This paper reviews the compelling evidence for probiotic efficacy, examines the FDA’s rationale, and contrasts US policy with global practices. It highlights the risk-benefit imbalance of withholding probiotics, analyzes the resulting clinical dilemma, and proposes a path forward through regulatory reform, ongoing research, and stakeholder collaboration to ensure access to this potentially life-saving intervention for preterm infants.