FDA Issues Probiotic Warning for Premature Infants Following Tragic Death
In a recent advisory, the US Food and Drug Administration (FDA) has expressed deep concerns over the administration of probiotics to infants born prematurely, emphasizing the possible life-threatening consequences it may entail. The agency’s advisory was instigated by the unfortunate death of a preterm baby who was administered the probiotic Evivo with MCT Oil at a medical facility.
Highlighting the gravity of this issue, the FDA has stated that certain bacteria and fungi present in probiotics could make premature babies susceptible to critical infections. The particular probiotic under scrutiny, Evivo with MCT Oil, is produced by Infinant Health specifically for hospital environments and comprises the Bifidobacterium longum infantis subspecies. Following the child’s tragic demise, an analysis showed that sepsis, stemming from this bacterium, was the cause of death. Alarmingly, genomic sequencing revealed that the bacteria causing sepsis in the baby was genetically identical to the one present in the administered probiotic.
In the US, probiotics are popular as dietary supplements, and their classification as such means they bypass the FDA approval process. Data from the American Academy of Pediatrics discloses that approximately 10% of preterm infants in neonatal ICUs are given probiotics, a trend that’s seen an upward trajectory. However, their latest guidelines voice against this practice. The primary concern is the unregulated nature of these probiotics, which raises questions on their safety and efficacy, especially for such a vulnerable demographic.
The FDA’s recent correspondence underscores that the agency hasn’t sanctioned any probiotic for infant use. Previously, the FDA had flagged Infinant Health for marketing Evivo with MCT Oil as a medication, terming it an “unapproved new drug.” Responding to these concerns, Infinant Health has initiated a recall of the contentious product, clarifying that their consumer variant, Evivo powder, is not embroiled in this controversy. Concurrently, recent studies in JAMA Pediatrics have suggested that probiotics could potentially benefit preterm infants. However, it’s crucial to differentiate between products with multiple bacterial strains and those like Evivo with MCT Oil that contain just one.
Legal Ramifications: Seeking Damages in Product Liability Lawsuits
Individuals or their guardians who believe they have suffered due to a product’s defect or misinformation might be entitled to seek compensation. If one thinks their child has been harmed due to the administration of a probiotic or any other product, they can consider filing a product liability lawsuit. In such lawsuits, the plaintiffs can potentially recover damages for medical expenses, pain and suffering, loss of consortium, and even punitive damages, depending on the circumstances and jurisdiction.
Manufacturers have an obligation to ensure the safety and efficacy of their products. Any failure in this duty, whether it is due to a manufacturing defect, design flaw, or insufficient warnings, can render them liable. The recent case against Infinant Health concerning Evivo with MCT Oil is a stark reminder of the ramifications companies might face if they neglect this duty.
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