Probiotic Safety Warning For Premature Babies (2023) After An Infant’s Death

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probiotic safety warning for premature babies

2023 Probiotic Safety Warning For Premature Babies 

What’s The Probiotic Safety Warning About?

On September 29, 2023, the FDA (Food and Drug Administration) issued a safety warning against using probiotics for premature babies after an infant died in a hospital. (1)(2)

According to the FDA’s warning letter issued to healthcare providers, the premature baby (birthweight <1000 g) was administered Infinant Health’s Evivo probiotic with MCT Oil as part of their in-hospital care. (1)(2)

However, the little one developed sepsis caused by Bifidobacterium longum, the same bacteria in the probiotic product. (1)(2)

Further tests and genomic sequencing data confirmed that the bacteria (live Bifidobacterium longum subsp. infantis) in the probiotic is a genetic match to the one that caused the baby’s death. (1)(2)

The FDA also issued and published a warning letter directly addressed to Infinant Health, Inc. (or formerly Evolve Biosystems Inc.) over violations concerning their “unapproved and unlicensed product.” (7)



According to CNN, the company has agreed to recall Evivo with MCT Oil. However, although the company claims to have informed hospitals and healthcare providers about this recall, no official recall has been posted on the FDA’s website as of writing. (2)


What Probiotic Products Are Affected?

The FDA’s warning isn’t limited to Evivo with MCT Oil but to all types of probiotics and any product that contains live bacteria, fungi, or other microorganisms. (1)(2)

Probiotics usually contain bacteria but can also have fungi. 

The federal agency warned that probiotics can put preterm babies at risk of invasive and potentially life-threatening diseases caused by their live, active components. (1)(2)


Studies & Previous Warnings Against Probiotic Use For Preterm Babies

The FDA warning also cites guidelines from the AAP (American Academy of Pediatrics), which reported that as many as 10% of extremely premature (low gestational age) newborns in the US receive probiotics in the NICU (neonatal intensive care unit). (3)

The AAP issued a warning against using probiotics for preterm infants (particularly those with low birth weights of <1000 g) through their recent guidelines, citing the following reasons: (3)

  • The lack of FDA-regulated pharmaceutical-grade probiotic products in the US
  • Conflicting data on probiotic safety and efficacy
  • The potential for harm in this highly vulnerable population (preterm infants)


Currently, the FDA doesn’t regulate probiotics because these are considered dietary supplements.

The FDA also reminds healthcare providers that the federal agency hasn’t approved any probiotic product for infants, whether as a drug or a biological supplement. (1)(2)

They acknowledge awareness of products marketed as a treatment or preventive strategy to help reduce the risks of NEC (necrotizing enterocolitis). This potentially deadly medical condition affects more preemies than full-term newborns.  (1)(2)

In the safety warning, the FDA points out that medical literature or research studies have reported incidents of bacteremia or fungemia (bacteria or fungi in the blood) linked to probiotic use in VLBW (very low birthweight) or very preterm infants. (1)

For example, seven cases of Saccharomyces fungemia from a probiotic product containing Saccharomyces cerevisiae were reported in a 2017 Mycoses journal study. These strains were also confirmed to genetically match the strains that caused the fungemia in the patients. (4)

A 2020 study in the Clinical Nutrition ESPEN (European Society for Clinical Nutrition and Metabolism) journal also reported one known case of Bifidobacterium longum bacteremia. (5)

The study also cited 13 other cases of bacteremia in very low birth weight or premature babies, still linked to probiotic use. (5)



Are Probiotics Good For Premature Babies?

Probiotics are commonly used at home and even in the hospital setting, especially to prevent and treat NEC. (3)

Discuss with your pediatrician the best course of action for your baby, especially because the FDA and the AAP warn against the risks of using them for preemies.


Are Probiotics Safe For Neonates (Newborns)?

If you’re wondering whether probiotics are safe for full-term newborns, we recommend discussing it with your pediatrician.

Although the FDA and AAP warnings above only cover probiotic use in premature babies, studies on probiotic effectiveness and safety have conflicting results. The lack of FDA regulation is also a primary cause of concern for probiotic products sold in the US. (6)

The AAP also points out that although full-term neonates might have fewer risks than preterm or low birth weight babies, they still belong to the vulnerable group. They can still be considered “high-risk” patient groups for probiotic use. (6)

On the other hand, some studies have also shown that probiotics, especially when combined with prebiotics and lactoferrin (protein in human milk) can be safe and effective in preventing preterm infants’ mortality (death) and morbidity (suffering from a disease). (8)

A 2023 literature review of 106 trials involving 25,840 premature babies found that probiotics can have these effects (compared to placebo): (8)

  • Multiple-strain probiotics can lead to reduced all-cause mortality
  • Multiple-strain probiotics alone or in combination with oligosaccharides (prebiotics) may be the most effective interventions to reduce severe necrotizing enterocolitis
  • Single-strain probiotics with lactoferrin may be the most effective against sepsis
  • Multiple-strain probiotics alone or in combination with oligosaccharides and single-strain probiotics can be more effective in reducing feeding intolerance
  • Single-strain and multistrain probiotics can be more effective in reducing the time to reach full tube or enteral feeding
  • Single-strain and multistrain probiotics can be more effective in reducing hospitalization duration


What Are The Effects Of Probiotics On Infants?

According to the AAP, probiotics are commonly used for the following clinical diseases in children: (6)

  • Acute infectious diarrhea
  • Antibiotic-associated diarrhea
  • Infantile colic
  • Constipation
  • Atopic (allergy-related) diseases or autoimmune responses
  • NEC (primarily with premature and low birth weight neonates)
  • Crohn’s disease or CUC (chronic ulcerative colitis)
  • IBS (irritable bowel syndrome) 
  • Extraintestinal infections (infections that occur outside the intestines)


What Are The Guidelines For Using Probiotics In Neonates?

There are currently no guidelines on the use of probiotics in neonates, and as already explained above, both the FDA and the AAP warn against their use, especially in premature infants. (1)(3)(6)

Our Probiotic Recommendations

If you have your pediatrician’s go-signal, here are our recommendations and top 5 choices for baby probiotics (read our article for more detailed reviews for each one):

LoveBug Baby Probiotic Drops



BioGaia Protectis Probiotic Drops


Culturelle Baby Grow



Gerber Good Start Soothe Comforting Probiotic Drops


Garden of Life Baby Probiotics


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