Probiotics are live microorganisms found in foods like yogurt, but they are increasingly marketed as health supplements. In a recent advisory communication, the FDA has warned hospitals about the use of probiotics for babies born prematurely (preterm). The warning came in late September 2023, mainly as a response to the news of the death of one preterm infant at a medical facility. The infant was given the probiotic Evivo with MCT Oil, which contains the infantis subspecies of the live bacterium Bifidobacterium longum. Evivo is manufactured by Infinant Health, and it is only administered under the supervision of healthcare professionals. A post-mortem of the infant found that the baby died through sepsis, which was proven through genome sequencing to have been caused by the same species of bacteria found in Evivo with MCT Oil. There is conflicting guidance on the safety and efficacy of probiotics for preterm infants, but lawsuits may follow if it becomes apparent that healthcare organizations, medical practitioners, and suppliers of probiotic supplements ignored warnings.

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The tragic death of an infant, coupled with the FDA’s warning, has refueled the debate over the use of probiotics to treat preterm infants. While the FDA’s response came in the fall of 2023, the debate is not a new one. According to the American Academy of Pediatrics, around 10% of preterm babies are provided with probiotics, and the number has increased in recent years. In response to the FDA’s warning, Infinant Health ordered a recall of Evivo with MCT Oil. It continues to sell other probiotic healthcare supplements. However, we should be clear that probiotics represent a broad field of supplements, and not all types of probiotics are being questioned, at least at the moment. Evivo with MCT Oil uses single-strain bacteria, whereas studies show that some multi-strain bacteria probiotics may be beneficial, even life-saving, for newborns in hospital care.

The FDA warning on probiotics for preterm infants is unusual for several reasons. First, the FDA does not approve probiotics as it does drugs, due to the fact that probiotics are considered dietary supplements. Secondly, the FDA’s warning was not a standard product advisory statement but rather a strong criticism of Infinant Health, denouncing its marketing of “an unapproved new drug and unlicensed biological product.” The FDA also remarked that Infinant Health may have violated the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Such actions may be considered important in any upcoming preterm probiotic lawsuits.

At this stage, we are only at the very beginning point of understanding the scope of the probiotics lawsuit. While Infinant Health was singled out in the FDA warning, there may well be more companies supplying unlicensed products to medical facilities. Nonetheless, anyone who has had their newborn come to harm through probiotics will inevitably want answers, and they may take the step of pursuing compensation through a lawsuit.

If your preterm infant was fed any products that contained probiotics (live bacteria or yeast) and, as a result, suffered death, injury, or sepsis, you may be eligible to join a probiotics lawsuit. As mentioned, probiotics is a broad term for live bacteria found in everyday products like yogurt, and it is possible that the probiotics lawsuits focus on single-strain bacteria products only. However, if you feel that your newborn has been harmed through supplement feeding while in hospital, you should contact a preterm probiotics lawsuit lawyer for more advice.

Are probiotics safe for preterm babies?

There is currently a debate over the safety of giving probiotics to preterm babies. Some studies have shown positive outcomes, whereas we know that a preterm infant recently died through sepsis which is believed to have been caused by a probiotic supplement. Always contact your healthcare provider for more advice before making any decision.

Are infant probiotics FDA approved?

Probiotics are considered dietary supplements, so they are not subject to approval status from the FDA. However, the FDA has recently sent out a warning on the use of certain probiotic supplements for preterm infants.

What is the effect of probiotics in preterm infants?

The effect of probiotics on preterm babies is up for debate, and it may depend on the type of probiotic. One supplement, Evivo with MCT Oil, has had to be recalled because it is suspected to have caused the death of a preterm infant.

How safe are probiotics in infants?

In short, we just don’t know. Experts have argued that probiotics can have life-saving functions in preterm infants under hospital care. On the other hand, there is evidence that certain probiotics may cause life-threatening incidents like sepsis.

Can probiotics have side effects in babies?

Yes. The case discussed above showed that the single-strain bacterium in the Evivo with MCT Oil probiotic likely caused sepsis in a newborn who later died in a medical facility. Probiotics are available over the counter (OTC), but you should always contact your child’s pediatrician for advice regarding the foods and medicines you give your infants.