Probiotics and Your Baby's Health: What Parents Need to Know

Recently, on September 29, the FDA raised a red flag that every parent should be aware of. They issued a warning to healthcare providers about specific probiotics for infants. This alert was prompted by a tragic incident involving a baby’s death, which was linked to a probiotic product called Evivo with MCT Oil, manufactured by Infinant Health, a California-based company[1]. As a result, this product has been recalled.

Understanding Probiotics

Before we dive deeper into probiotics and their use, let’s demystify what probiotics are. Probiotics are live microorganisms, usually beneficial bacteria, that are believed to provide health benefits when consumed in adequate amounts. They’re often referred to as “good or friendly” bacteria because they’re thought to promote a balanced gut microbiome, which can contribute to overall health[1].

Probiotics and NEC in Infants

In theory, probiotics were expected to help infants, especially preterm and underweight ones, by populating their developing gut with beneficial bacteria. This could potentially strengthen their immature immune systems and reduce the risk of necrotizing enterocolitis (NEC), a condition characterized by inflammation and tissue death in the intestines[1]. NEC is more common in preterm infants, and the hope was that probiotics could play a role in preventing this life-threatening condition.

The Science Behind the Danger

Now, let’s talk about why giving live microorganisms, like probiotics, to vulnerable infants can be risky. Infants, especially preterm ones, have developing immune systems that may not be able to fend off harmful bacteria introduced by probiotics. When live bacteria from a probiotic enter the bloodstream, it can lead to a condition called sepsis.

Sepsis is a severe, often life-threatening infection that can cause widespread inflammation throughout the body[2]. In the case of the recent FDA warning, genomic sequencing data revealed that the bacterium responsible for sepsis in the infant matched the bacteria in the probiotic. This genetic match was a crucial piece of evidence that raised concerns about the safety of probiotics for preterm infants. But it does not stop there – the FDA has also received reports of over two dozen adverse events related to probiotics in the United States since 2018. They are actively investigating these cases and gathering medical records and other evidence, including those potentially linked to fatalities.

A Broad Warning

Here is where it gets crucial for all parents. The FDA’s warning is not limited to one specific product; it covers all probiotics that contain live bacteria or yeast. But why is this a big deal? Probiotics are commonly used in hospitals to prevent a condition called necrotizing enterocolitis, which primarily affects newborns and can be life-threatening, with a mortality rate as high as 50%, according to the National Institutes of Health.

The FDA stressed an important point: They have not approved any probiotic product for use as a drug or biological product in infants, regardless of their age. Typically, probiotics are marketed as foods or supplements. The FDA is deeply concerned about the use of these products for the treatment or prevention of diseases in preterm infants in hospital settings.

Expert Insights

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, wants parents to be aware of how serious the situation is. The FDA is concerned about any side effects associated with probiotic use in newborns, but they are especially concerned about the risks that products containing live bacteria offer to preterm infants in hospital settings.

Off-Label Use Based on Science

Healthcare providers may have initially recommended probiotics off-label for preterm infants based on scientific studies suggesting that certain probiotic strains could potentially reduce the risk of NEC. However, these studies were not always definitive, and the risks associated with administering live microorganisms were not fully understood.

It’s important to note that the FDA had not approved any probiotic product for use as a drug or biological product in infants of any age. The recent warning serves as a reminder of the potential risks involved when using probiotics in infants, especially in the absence of rigorous premarket evaluations for safety and effectiveness. The goal is to ensure that healthcare decisions are based on the most robust and up-to-date scientific evidence to protect the health and well-being of our most vulnerable patients.

Taking Action

Following the recall of Infinant Health’s Evivo with MCT Oil product, the FDA issued a warning letter to Abbott Laboratories regarding its Similac Probiotic Tri-Blend. Abbott decided to discontinue the product and is actively working with the FDA to address the issue.

So, what’s the bottom line for parents? The FDA’s recent warning about certain probiotic products is a matter of utmost importance when it comes to your baby’s health. As parents, it’s essential to stay informed and be cautious when considering probiotics for your infants, especially if they’re preterm and in the hospital. Your child’s health and safety are paramount, and it’s crucial to choose products that have undergone rigorous evaluations for safety, effectiveness, and quality.


[1] https://www.cbsnews.com/news/fda-warning-probiotics-preterm-infant-death-linked-evivo/

[2] https://www.nccih.nih.gov/health/probiotics-what-you-need-to-know#:~:text=Probiotics%20are%20live%20microorganisms%20that,dietary%20supplements%2C%20and%20beauty%20products

[3] https://www.nature.com/articles/pr200824