Cautionary Alert: FDA Sounds Alarm on Infant Probiotic Use, Citing Linked Deaths and Illnesses in Recent Cases

Cautionary Alert: FDA Sounds Alarm on Infant Probiotic Use, Citing Linked Deaths and Illnesses in Recent Cases

  • 27.10.2023 17:32

FDA Issues Urgent Warning: Probiotic Use Poses Grave Risks for Infants

In a stark advisory, the Food and Drug Administration (FDA) has sounded the alarm on the potential fatal consequences of probiotic use in infants. The warning, issued recently, highlights the perilous nature of probiotics—products containing live bacteria and yeasts—especially for pre-term babies. According to the FDA, these infants face an increased risk of invasive and potentially fatal diseases or infections caused by the bacteria or yeast contained in probiotics.

Of particular concern are probiotics that are illicitly sold and marketed as remedies for specific diseases in hospital settings, such as necrotizing enterocolitis—a deadly intestinal disease that frequently afflicts pre-term babies. The FDA noted a disturbing connection between certain probiotics and one infant death this year, along with more than two dozen "adverse events" reported since 2018.

Crucially, probiotics have not received FDA approval for use in infants, a stance mirrored by the American Academy of Pediatrics. Despite this, an estimated 10% of newborns with extremely low gestational age receive probiotics in neonatal intensive care units, exposing them to potential risks.

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, emphasized the serious risks posed by live microorganisms in these products, especially in hospital settings. The FDA's message is clear: parents, caregivers, and healthcare providers should be cautious as these products have not undergone the rigorous premarket evaluation process for safety, effectiveness, and quality required for medical uses.

In response to these concerns, the FDA has recently issued warnings to companies violating regulations. Abbott Laboratories and Infinant Health, Inc. were both reprimanded for marketing probiotic products to infants. Infinant Health, Inc.'s "unapproved and unlicensed" Evivo with MCT Oil led to a voluntary recall, while Abbott Laboratories' Similac Probiotic Tri-Blend, intended for hospital settings for preterm infants, has been discontinued.

This urgent advisory serves as a critical reminder of the potential dangers associated with unregulated probiotic use in the vulnerable population of pre-term infants, urging a reassessment of current practices and heightened awareness among both consumers and healthcare providers.

Clarification Amidst Concerns: Abbott Laboratories Responds to FDA Warning

In response to the FDA's recent warning regarding probiotic products for infants, Abbott Laboratories, the manufacturer of Similac Probiotic Tri-Blend, sought to provide clarity and assurance to concerned parents and caregivers. The company emphasizes that the FDA's advisory does not extend to any of Abbott's infant formula products available for retail purchase, and parents can continue to confidently find and use Similac infant formulas nationwide.

Abbott further clarified that the FDA's warning letter did not involve issues related to manufacturing quality. The company asserts that Similac Probiotic Tri-Blend has been utilized for several years with a robust safety profile. This reassurance aims to address any apprehensions regarding the overall quality and safety of Abbott's infant formula products.

Jim Jones, the FDA’s Deputy Commissioner for Human Foods, underlined the agency's commitment to safeguarding public health, particularly among vulnerable populations like preterm infants. He reiterated the FDA's dedication to further investigate any potential risks associated with the administration of probiotic products to preterm infants in hospital settings.

As concerns linger, Abbott Laboratories remains steadfast in its commitment to transparency and the well-being of infants. The company encourages continued vigilance among all stakeholders involved in the care of preterm infants, urging awareness of potential risks and adherence to the highest standards of safety in healthcare practices.

Navigating Assurance Amid FDA Advisory

In the aftermath of the FDA's warning regarding probiotic products for infants, Abbott Laboratories moves swiftly to offer clarity and reassurance. Emphasizing that the advisory does not extend to their retail infant formula products, Abbott affirms the continued safety and availability of Similac infant formulas nationwide.

The company's prompt response aims to allay concerns, highlighting that the FDA's cautionary letter does not implicate manufacturing quality. With a history of several years of use and a strong safety profile, Similac Probiotic Tri-Blend is asserted to have maintained a standard of reliability.

Jim Jones, the FDA’s Deputy Commissioner for Human Foods, underscores the agency's commitment to protecting public health, particularly among vulnerable populations like preterm infants. The promise of further investigation into potential risks associated with probiotic product administration reflects the FDA's dedication to ensuring the highest standards of safety in healthcare practices.

As the industry grapples with these concerns, Abbott Laboratories stands firm in its commitment to transparency and the well-being of infants. The conclusion urges ongoing vigilance among parents, caregivers, and healthcare providers, fostering awareness of potential risks and adherence to stringent safety protocols in infant care. In navigating this evolving landscape, a collaborative effort is paramount to safeguarding the health of our most vulnerable.