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The Risks of Probiotic Use in Preterm Infants: FDA Warning and Recommendations

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In recent years, probiotic products have gained popularity as a dietary supplement for promoting gut health. However, a recent series of events involving preterm infants has led the U.S. Food and Drug Administration (FDA) to issue a warning about the potential risks associated with using probiotics in this vulnerable population. This article aims to explore the FDA’s warning, the reported cases of injuries and deaths, and the implications for healthcare providers and caregivers.

FDA warns about giving probiotics to babies after infant death

Understanding Probiotics and their Use

Probiotics are live microorganisms, such as bacteria or yeast, that are believed to provide health benefits when consumed. They are commonly marketed as foods or dietary supplements. While probiotics have gained recognition for their potential positive effects on gut health, it’s essential to note that no probiotic products have been approved by the FDA for use as drugs or treatments in infants.

The FDA’s Warning and Investigations

The FDA’s warning comes in response to injuries and at least one death in premature infants who were given probiotic products in the hospital. The agency has received reports of more than two dozen injuries associated with these products since 2018. The recent death of a preterm baby who received a probiotic called Evivo with MCT Oil prompted the FDA to investigate further.

Understanding the Risks

According to the FDA, preterm infants who are given probiotics are at risk of developing invasive and potentially fatal infections or diseases caused by the bacteria or yeast present in these products. The agency has identified the bacterium Bifidobacterium longum as a potential culprit in the reported cases. Genetic sequencing confirmed that the bacterium that caused sepsis in the deceased infant was a genetic match to the bacteria contained in the probiotic product.

Lack of FDA Approval and Regulations

One of the key concerns highlighted by the FDA is the lack of FDA-approved probiotic products for use in infants. Unlike drugs or biological products, probiotics fall under the category of dietary supplements, which are not subject to the same rigorous manufacturing and testing standards. This regulatory gap raises concerns about the safety, effectiveness, and quality of probiotics, particularly in vulnerable populations like preterm infants.

Warning Letters and Recalls

As part of their response, the FDA has issued warning letters to companies illegally marketing probiotic products for use in preterm infants. Abbott Laboratories, a well-known infant formula manufacturer, received one of these letters due to its Similac Probiotic Tri-Blend product. Abbott has agreed to discontinue sales of the product and work with the FDA on corrective actions. Another company, Infinant Health, which produced the recalled probiotic Evivo with MCT Oil, has also voluntarily recalled and discontinued the product.

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Recommendations for Healthcare Providers and Caregivers

The FDA’s warning serves as an important reminder for healthcare providers and caregivers to exercise caution when considering the use of probiotic products in preterm infants. It is crucial to weigh the potential benefits against the potential risks, particularly when these products have not undergone the FDA’s rigorous premarket evaluation for safety, effectiveness, and quality in medical uses.

American Academy of Pediatrics Guidelines

The American Academy of Pediatrics (AAP) has also weighed in on the use of probiotics in preterm infants. Their most recent guidelines do not recommend the routine, universal administration of probiotics to preterm infants, especially those with a birth weight of less than 1000 grams. The lack of FDA-regulated pharmaceutical-grade probiotic products, conflicting data on safety and efficacy, and the potential for harm in a vulnerable population all contribute to the AAP’s cautious stance.

The Potential Benefits of Probiotics

While the FDA’s warning raises concerns about the use of probiotics in preterm infants, it’s important to note that research has suggested potential benefits in certain cases. A review of 106 trials, including nearly 26,000 infants, published in JAMA Pediatrics, found that probiotics with multiple strains of bacteria helped reduce overall infant death, feeding intolerance, and necrotizing enterocolitis, a life-threatening inflammation of the intestines. However, it’s important to distinguish between the products studied in these trials and the specific probiotics implicated in the FDA’s warning.


The FDA’s warning about the use of probiotics in preterm infants highlights the potential risks associated with these products. Healthcare providers and caregivers should exercise caution and consider the lack of FDA approval, potential for harmful infections, and the cautious stance of organizations like the AAP. As research continues to explore the benefits and risks of probiotics, it is crucial to prioritize the safety and well-being of preterm infants in medical decision-making.


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