FDA warns hospitals about probiotics after death reported.
The FDA Warns Hospitals About Probiotics for Preterm Infants After Baby’s Death
The U.S. Food and Drug Administration (FDA) has issued a strong warning to hospitals regarding the use of probiotics in preterm infants, following the tragic death of a baby. The FDA’s investigation revealed that the infant had been given the probiotic Evivo with MCT Oil, manufactured by Infinant Health, as part of their in-hospital care. Tragically, the child later developed sepsis caused by the bacterium Bifidobacterium longum and passed away.
“Genomic sequencing data demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this probiotic,” stated the FDA’s letter.
It is crucial to note that probiotics are not approved for use as drugs or biological products in infants, according to the FDA. They are considered supplements and are not subjected to the agency’s rigorous manufacturing and testing standards. The FDA also reminded healthcare providers that no probiotic product has been approved for use in infants.
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The American Academy of Pediatrics has also cautioned against the routine administration of probiotics to preterm infants due to conflicting data on safety and efficacy. They emphasize the lack of FDA-regulated pharmaceutical grade products and the potential harm to this vulnerable population.
Infinant Health, the manufacturer of Evivo with MCT Oil, has stated that they are cooperating with the FDA’s ongoing investigation and have ceased distribution of the product. They claim that their products are widely used in hospitals, particularly in neonatal intensive care units, and are clinically shown to work with breast milk to establish a healthy gut microbiome.
Contrary to the FDA’s warning, a recent survey published in JAMA Pediatrics suggests that probiotics with multiple strains of bacteria can reduce infant deaths and inflammation of the intestines caused by necrotizing enterocolitis.
It is essential for healthcare providers and parents to be aware of the FDA’s warning and exercise caution when considering the use of probiotics in preterm infants.
What is the NEC Society statement on probiotics?
What do studies show about probiotics and NEC? Certain probiotics can reduce the risks of NEC in premature infants. When given prophylactically to premature infants, certain probiotics have been shown to reduce the risk of infections and even death. Ents and therefore fall under different regulations. However, hospitals have been using probiotics off-label in preterm infants to promote the development of healthy gut bacteria and prevent conditions such as necrotizing enterocolitis (NEC), which can be life-threatening for premature babies.
The FDA’s warning comes after analyzing the case of the unfortunate infant who had received Evivo with MCT Oil. The investigation revealed that the bacterium found in the probiotic was responsible for the sepsis that ultimately led to the child’s death. This genetic match between the bacteria in the probiotic and the one causing sepsis raises serious concerns about the safety and efficacy of using probiotics in preterm infants.
Probiotics are live microorganisms that, when administered in adequate amounts, are beneficial to the host’s health. They are believed to promote a healthy balance of gut flora, aid digestion, support the immune system, and prevent harmful bacteria from colonizing the intestines. In adults and older children, probiotics have shown promise in treating certain gastrointestinal conditions. However, their use in preterm infants is still relatively new and lacks strong scientific evidence.
The FDA’s warning to hospitals serves as a reminder that the use of probiotics in preterm infants is not without risk. There have been previous reports of serious infections, including cases of sepsis, associated with the use of probiotics in this vulnerable population. While some studies have shown potential benefits, more research is needed to establish the safety and effectiveness of probiotics in preterm infants.
In light of these findings, the FDA has urged hospitals to reassess their use of probiotics in preterm infants and to consider alternative strategies for promoting gut health. The agency has emphasized the need for healthcare providers to adhere to established guidelines and consult with experts in neonatology and pediatric infectious diseases when considering the use of probiotics in preterm infants.
Manufacturers of probiotics have also been alerted to the FDA’s concerns and have been urged to ensure the safety and quality of their products, particularly for use in vulnerable populations such as preterm infants. The FDA has called for greater transparency and better labeling of probiotic products to accurately reflect their intended use and potential risks.
While the use of probiotics in preterm infants may hold promise in the future, it is essential to proceed with caution and prioritize patient safety. Rigorous research and stringent oversight are necessary to determine the appropriate use, dosage, and strains of probiotics in this population. Until then, hospitals and healthcare providers must carefully weigh the potential benefits against the risks and prioritize evidence-based practices to ensure the well-being of preterm infants under their care.
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