FDA warns against administering probiotics to newborns following the death of an infant

By Claire Wolters | Fact-checked by Davi Sherman
Published November 1, 2023

Key Takeaways

  • An infant died after being administered an illegally marketed probiotic.

  • Now, the FDA is warning against probiotic use for newborns, which are unapproved and unlicensed for infants and can pose risks like sepsis or even death.

The United States Food and Drug Administration (FDA) is warning doctors about the risks that probiotic products pose to preterm infants in hospital settings.

The warning follows a case of a newborn dying from sepsis after being given Evivo with MCT Oil, an unapproved and unlicensed product that, according to the FDA, Infinant Health, Inc illegally sold in hospitals to treat diseases in preterm infants.[]

The FDA wrote in a press release that it has not approved probiotic drugs for use in infants of any age, particularly those who are preterm and have a low birth weight. According to research by the American Academy of Pediatrics, “current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of <1000 g.”[]

The agency sent warning letters to probiotic manufacturers this fall, detailing their missteps, and to healthcare providers, warning of product risks and encouraging adherence to FDA-vetted protocols.

In its warning letter to Infinant Health, Inc, the FDA addressed how the company directly marketed its probiotic for use in infants aged 0 to 36 months despite the drug’s risks and lack of approval and licensing. The agency also wrote to Abbott Laboratories, another company that illegally marketed probiotics—its Similac Probiotic Supplement—for use in preterm infants.

In the letter to Abbott Laboratories, the FDA addressed the company’s contradictory marketing materials, including its Similac Probiotic Supplement label.

The FDA told Abbott Laboratories that while the product “label states that the product is ‘not intended for infants with compromised intestinal permeability,’ and your Pediatric Product Nutrition Guide states that your product is ‘not intended for infants with intestinal permeability,’ other marketing materials of yours directly contradict these statements.” The agency pointed to an infographic titled, “How Probiotics Can Help My Preterm Infant, Infancy is an Important Time in Developing a Healthy Gut Microbiome,” as an example.

Both Infinant Health, Inc and Abbott Nutrition have since voluntarily recalled the products. 

How can probiotics impact newborns?

Probiotics can increase an infant’s risk for serious and life-threatening infections like sepsis, says Ilan Shapiro, MD, MBA, FAAP, FACHE, a pediatrician and Chief Health Correspondent and Medical Affairs Officer at AltaMed Health Services.

“What we know about probiotics, especially with kids who have problems with their gut or were born premature, is that the bacteria and yeast can go inside the bloodstream and create an infection the body will not know how to respond to,” Dr. Shapiro says. “The recommendation in the past was not clear, but mounting evidence now shows there's no advantage [to] using probiotics in the early stage of life.”

At times, infants have been given probiotics as a prevention treatment for necrotizing enterocolitis (NEC). NEC is a life-threatening illness that can cause inflammation of the intestine, leading to bacterial invasion causing, cellular death, and necrosis of the intestine and colon; this often leads to death in newborns.[]

“Necrotizing enterocolitis is one of the most devastating problems we can have, especially among babies born premature,” Dr. Shapiro says. “Sadly, even though we do much to prevent it, it still happens.”

Some studies suggest probiotic use in newborns may reduce NEC risks. However, doctors and researchers note that, as a whole, studies have been contradictory and lack comprehensive comparisons of specific bacterial strains and recommendations regarding optimal doses and duration of treatment. Furthermore, the benefits of probiotics for newborns cannot be assessed without studying their risks, which can include sepsis or potential death, as in the incident being investigated.[]

In its press release, the FDA states that it “understands there are conflicting data in the literature on the safety and effectiveness of probiotics for the prevention of necrotizing enterocolitis, and that the study of the use of probiotics has been complicated by several factors, including the use of different probiotics in different trials.”

To reduce the risks of NEC without probiotics, Dr. Shapiro says, “the best advice is to follow neonatal intensive unit guidelines for feeding” and to evaluate the infant daily.

Reporting unapproved and unlicensed probiotics 

The FDA encourages healthcare providers not to administer probiotics to newborns but directs those who do to first submit an Investigational New Drug (IND) application, which can provide doctors with some safeguards for use. To be considered for FDA approval, probiotic drugs must also undergo the Biologics License Applications (BLA) Process.

“[P]roducts containing live microorganisms may present serious risks to preterm infants in hospital settings,” Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research, said in the press release. “[W]e want to warn parents, caregivers, and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agency’s rigorous premarket process to evaluate their safety, effectiveness, and quality for these medical uses.”

What this means for you

Due to the risks of deadly infections, the FDA is warning against probiotic use for treating newborns in hospital settings. Two companies marketing probiotics to newborns have since voluntarily recalled their products.

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