FDA warns hospitals about giving probiotics to preemies following one death.
FDA warns hospitals about giving probiotics to preemies following one death.
Probiotics Can Be a Risky Business for Preterm Infants
Babies are adorable bundles of joy, but they also have delicate systems that require special care. When it comes to preterm infants, caution should be exercised even more. In a recent warning letter, the U.S. Food and Drug Administration (FDA) revealed a heartbreaking incident involving a preterm infant who died after being given probiotics at an undisclosed hospital[^1^]. This tragedy has prompted federal regulators to urge doctors to refrain from giving probiotics to preterm infants.
The Dangers of Probiotics for Preterm Infants
Preterm infants, especially those who weigh less than 2.2 pounds, are at an increased risk of developing potentially fatal infections if given probiotics[^1^]. The FDA warns that these supplements may contain bacteria and fungi that can be harmful to these vulnerable babies. In this particular case, the infant developed sepsis caused by a type of bacteria that was genetically identical to that found in the probiotic given to him[^1^]. This is not the first instance where microorganisms found in probiotics have caused illness in very preterm or low birthweight babies[^1^].
The American Academy of Pediatrics’ Guidelines
The American Academy of Pediatrics (AAP) supports the FDA’s warning, citing conflicting data on safety and efficacy, and the potential for harm to this vulnerable population[^1^]. The AAP emphasizes that the current evidence does not support the routine use of probiotics, particularly for preterm infants weighing less than 2.2 pounds[^1^]. It is important to note that the FDA has not approved any probiotic products for use in infants[^1^]. However, some products are marketed without approval, claiming to prevent the risk of a condition called necrotizing enterocolitis in preterm infants[^1^].
Necrotizing enterocolitis is a serious condition characterized by inflammation of the intestine, leading to bacterial invasion that causes cell death in the colon and intestine[^1^]. It is crucial to prioritize the safety and well-being of preterm infants by avoiding unapproved probiotic products.
The Investigation and Actions Taken
The probiotic in question was manufactured by California-based Infinant Health[^1^]. The company has expressed their cooperation with the FDA’s ongoing investigation and has voluntarily halted the shipment of their Evivo with MCT Oil product[^1^]. This demonstrates a commitment to ensuring the safety of preterm infants.
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Reporting Adverse Events
Healthcare providers and consumers are urged to report any adverse events related to probiotics to the manufacturer and the FDA[^1^]. This information can be provided either through the contact details on the product label or by contacting the FDA directly. Prompt reporting is essential to help prevent further harm.
Conclusion
As we marvel at the beauty of newborn babies, we must also remember the fragility of their young lives. The recent tragedy involving the death of a preterm infant serves as a solemn reminder of the potential risks associated with probiotics for this vulnerable population[^1^]. Healthcare professionals and parents alike should adhere to the FDA and AAP guidelines, ensuring the safety and well-being of preterm infants.
