A recent incident has sparked worries about the safety of probiotics, with a preterm infant allegedly losing their life after being administered the probiotic Evivo with MCT Oil. This incident has prompted the Food and Drug Administration (FDA) to initiate an investigation into the use of such supplements in hospitals, particularly among vulnerable populations like infants.

FDA's Investigation and Warning: Following the tragic incident, the FDA has launched an investigation into the death of the infant associated with the probiotic supplement. The agency has also issued a warning regarding the potential risks of probiotics, emphasizing the need for caution, especially in vulnerable populations.

Genome Sequencing Unveils Concerns: Genome sequencing revealed that the infant succumbed to sepsis caused by a strain of bacteria present in the probiotic itself. This raises significant questions about the safety and proper use of dietary supplements, particularly in cases involving preterm infants.

Probiotics and why we consume them: While probiotics have gained popularity for potential health benefits, it's crucial to recognize their risks. Probiotics are live microorganisms believed to enhance health when consumed adequately. These supplements come in various forms and are often marketed to improve digestive health, boost the immune system, and address various health issues.

Potential Risks of Probiotics:

1. Infection Risks: Individuals with weakened immune systems, such as those recovering from critical illnesses or recent surgery, may be at a higher risk of infections introduced by probiotic supplements. The live microorganisms in probiotics can pose a threat to individuals with compromised immune function.

2. Allergic Reactions: Probiotics may trigger allergic responses in certain individuals. This includes symptoms such as skin rashes, itching, swelling, and difficulty breathing.

3. Digestive Distress: In the initial days of probiotic use, individuals may experience moderate stomach distress, gas, and diarrhoea. This digestive discomfort can be a temporary side effect, but it underlines the need for careful monitoring, especially during the initial phases of supplementation.

4. Unregulated Products: The lack of regulated pharmaceutical-grade probiotic products raises concerns about the quality and consistency of available supplements. Consumers should exercise caution when choosing probiotic products, ensuring they come from reputable sources.

5. Limited Research in Specific Populations: Despite the popularity of probiotics, there is a notable gap in significant research, especially concerning specific populations such as infants. The incident involving the preterm infant highlights the need for more targeted research to understand the potential risks and benefits in vulnerable groups.

FDA's Cautionary Measures: The FDA is cautioning hospitals against administering probiotics to preterm infants, especially in light of the recent fatality. Despite probiotics appearing in infant formulas and supplements, there's a lack of significant research on their safety and efficacy in infants. The American Academy of Pediatrics also recommends against the widespread use of probiotics for preterm infants.


In conclusion, while probiotics offer potential health benefits, this incident highlights the importance of careful consideration, especially in vulnerable populations. The FDA's investigation aims to shed light on the safety of probiotics, urging healthcare practitioners and consumers to approach these supplements with caution, particularly when dealing with infants and other at-risk individuals.