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FDA Issues Urgent Warning on Probiotics for Premature Babies Following Infant Fatality

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"FDA Issues Urgent Warning on Probiotics for Premature Babies Following Infant Fatality; Abbott Laboratories Discontinues Product After Agency's Letter"

The US Food and Drug Administration (FDA) has sounded a fresh alarm on the potential risks associated with probiotics for hospitalized preterm infants. Citing over two dozen reported adverse events since 2018, including a tragic death in 2023, the FDA has heightened concerns regarding the safety of these products. In a significant move, the agency issued a warning letter to Abbott Laboratories specifically addressing its Similac Probiotic Tri-Blend product. The FDA deemed it an "unapproved new drug" and an "unlicensed biological product" based on statements found in marketing materials and on the company's website.

Abbott Laboratories has responded by agreeing to cease the sales of the product in question. The company clarified that the issue pertains to a single probiotic additive for Similac Probiotic Tri-Blend, used by fewer than 200 hospitals and not affecting Abbott infant formula products. Despite the warning, parents and caregivers are assured that Similac infant formulas nationwide remain safe for use, as the FDA emphasizes that the concern is not related to any manufacturing quality issue.

Probiotics, known for their live bacteria or microorganisms promoting health benefits, are widely used in the US as dietary supplements. However, these supplements do not undergo the rigorous FDA approval process. In hospitals, probiotics are often administered to prevent necrotizing enterocolitis (NEC), a life-threatening inflammation of the intestines in preterm infants. Dr. Katherine Chetta, a pediatric neonatologist, notes that NEC affects up to 1 in 20 premature infants, causing approximately one baby's death each day.

The American Academy of Pediatrics reports a steady increase in the use of probiotics in neonatal ICUs, with around 10% of preterm infants receiving them. Probiotics are considered a crucial tool in preventing NEC, according to health care providers. However, the FDA acknowledges "conflicting data" on the safety and effectiveness of probiotics for this purpose and urges further "high-quality clinical trials" to provide conclusive evidence. The cautionary measures underscore the need for a nuanced and evidence-based approach to the use of probiotics in neonatal care.

"FDA Issues Stark Warning on Probiotics for Preterm Infants: Recent Infant Fatality Prompts Caution"

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, has expressed deep concern over adverse events in infants linked to the use of probiotics, particularly emphasizing the serious risks they may pose to preterm infants in hospital settings. This statement follows a recent incident in which an infant died after receiving the probiotic Evivo with MCT Oil, manufactured by Infinant Health for hospital use. The product contained the infantis subspecies of the live bacterium Bifidobacterium longum, leading to sepsis and the infant's tragic demise.

In response to this, the FDA issued a warning letter cautioning health care providers about the potential dangers of bacteria and fungi present in probiotics, highlighting the risk of "invasive, potentially fatal" infections for preterm infants. The affected product was recalled and is no longer available in the US.

The FDA underscored that it has not approved any probiotic products for infants of any age, emphasizing that these products have not undergone evaluation for safety, effectiveness, or compliance with manufacturing and testing standards. Dr. Marks delivered a strong message to parents, caregivers, and healthcare providers, warning them that these products, if used for the prevention or treatment of disease, have not undergone the FDA's rigorous premarket process.

Contrary to the FDA's caution, some physicians express concern about the opposition to probiotic therapy. While the American Academy of Pediatrics does not recommend these supplements for preterm infants, the debate continues, with physicians weighing the potential benefits against the lack of FDA-regulated pharmaceutical-grade products, conflicting safety data, and the vulnerability of the preterm infant population. The ongoing discourse highlights the complex landscape surrounding probiotic use in neonatal care and the need for a careful and evidence-based approach to ensure the well-being of the youngest and most vulnerable patients.

"In Defense of Probiotics: Hospitals Navigate a Delicate Balance for Infant Health"

Dr. Katherine Chetta sheds light on the delicate balance hospitals face in utilizing probiotics for infants undergoing treatment. Antibiotic therapies, crucial in many hospital settings, can disrupt the delicate microbiome in a baby's gut, eradicating beneficial bacteria while allowing harmful strains like E. coli to proliferate. Probiotics emerge as a valuable tool in this scenario, aiding in the reintroduction of diverse and healthy bacteria, thereby reconstructing the microbiome and reducing the risk of infections such as necrotizing enterocolitis (NEC).

Chetta emphasizes the significance of probiotics, citing data supporting their use, particularly in hospitals that carefully select and administer probiotics based on observed efficacy. Hospitals like hers report a decrease in sepsis, NEC, and mortality rates among infants receiving probiotics. Despite the absence of FDA approval for these treatments, Chetta contends that the real concern lies in when such approval will be granted.

Acknowledging a minimal risk — approximately 1 in 5,000 infants developing sepsis from probiotics, significantly lower than the risk of NEC — Chetta stresses the importance of informed decision-making. Parents are involved in the risk assessment process, weighing the unapproved status of probiotics against their proven effectiveness. Chetta argues against a blanket removal of probiotics, advocating instead for a thoughtful approach to ensure infants receive the necessary medicines and supplements safely.

The discourse reflects the ongoing challenge of balancing the potential benefits of probiotics with regulatory considerations, emphasizing the need for nuanced solutions that prioritize infant health in hospital settings.

In conclusion, the debate surrounding the use of probiotics in hospital settings for infant health reveals a delicate balance between potential benefits and regulatory considerations. Dr. Katherine Chetta's perspective highlights the vital role probiotics play in restoring the microbiome of infants undergoing antibiotic treatment, mitigating the risk of infections like necrotizing enterocolitis (NEC). Despite the lack of FDA approval, hospitals, including Chetta's, report positive outcomes and a reduction in sepsis, NEC, and mortality rates among infants treated with probiotics.

Chetta emphasizes the necessity of finding a safe solution rather than outright removal of probiotics, underscoring the importance of informed decision-making. Engaging parents in the evaluation of risks and benefits becomes a crucial aspect of the process, allowing for a more personalized and considerate approach to infant care.

The ongoing dialogue raises broader questions about regulatory processes and the urgency for approval of probiotic products. As healthcare providers navigate this complex landscape, the focus remains on ensuring that infants receive necessary medications and supplements safely. The resolution lies in a careful and evidence-based approach that prioritizes the well-being of the youngest and most vulnerable patients, acknowledging both the potential benefits and the need for regulatory clarity in the realm of infant healthcare.

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