A preterm infant has died after receiving Evivo with MCT Oil probiotic in the hospital. That dietary supplement, produced by Infinant Health, is formulated to contain the live bacterium Bifidobacterium longum subsp. infantis, according to the FDA. The infant developed sepsis caused by that bacterium. The FDA is investigating this death. Genomic sequencing data found that the bacteria that caused sepsis in the infant was a genetic match to the bacteria in the probiotic.
The FDA is now warning that preterm infants who are given these dietary supplements are “at risk of invasive, potentially fatal disease caused by the bacteria or fungi contained in probiotics.” Medical literature reports state that microorganisms in probiotics have caused bacteremia or fungemia, sometimes with severe health effects, in very preterm or very low birthweight infants.
The American Academy of Pediatrics states, “Given the lack of FDA-regulated pharmaceutical- grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of <1000 g.”
The FDA has not approved any probiotic product for use as a drug or biological product in infants. Some unapproved, unlicensed probiotics are still being sold for use to treat or prevent disease in infants, including reducing the risk of necrotizing enterocolitis in preterm infants. Healthcare providers should know that these products have not undergone the FDA’s rigorous premarket review evaluations for safety and effectivness, and they have not been evaluated for compliance with the agency’s manufacturing and testing standards for biological products and drugs, which includes testing for extraneous organisms.
Any healthcare providers who administer probiotics containing live bacteria or yeast to treat, mitigate, cure, or prevent a disease are required to submit an Investigational New Drug Application to the FDA. And the FDA is encouraging healthcare providers and consumers to repot any adviser events following the use of probiotics to the manufacturing and to the FDA through that agency’s MedWatch Adverse Events Reporting System.
If you or a family member have been sickened with a food poisoning infection, please contact our experienced attorneys for help with a possible lawsuit at 1-888-377-8900 or text us at 612-261-0856. Our firm represents clients in lawsuits against grocery stores, restaurants, and food processors, and families in wrongful death cases
