FDA Issues Warning on Probiotics After Baby Dies

The FDA issued a warning on probiotics for certain infants.

A sign for the Food and Drug Administration (FDA) outside of the headquarters in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

The U.S. Food and Drug Administration (FDA) on Thursday warned that probiotics for preterm infants could result in fatal health risks.

The agency said that one infant death was linked to probiotic products earlier this year. It said that since 2018, more than two dozen adverse incidents involving infants were linked to the products, and the agency is also investigating other cases.

“Probiotic products contain live organisms such as bacteria or yeast and are commonly marketed as foods, including as dietary supplements,” the health regulator said in a news release Thursday.

According to the FDA, it has not approved any probiotics for infants of any age. However, some have probiotics to treat some diseases for preterm infants in hospitals, the notice said.

The agency said that “these products can be dangerous for preterm infants and are being illegally sold to treat or prevent diseases” and pose the risk of an “invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics.”

“The warning letter notes the company sells the probiotic product for use in hospital settings for preterm infants,” it added. “Based on the intended uses on the company’s websites and Abbott’s marketing materials, the product is an unapproved new drug and an unlicensed biological product being sold in violation of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.”

The notice made mention of a preterm infant who had been given a probiotic product, Evivo with MCT Oil, made by Infinant Health. The unnamed child developed sepsis, a potentially deadly condition that occurs when an infection triggers a chain reaction throughout the body, leading to organ failure and tissue damage.

It’s not clear what hospital administered the probiotic, which contains the infantis subspecies of the live bacterium Bifidobacterium longum. Other details about the incident weren’t provided.

“We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,” Dr. Peter Marks, a top FDA official, said on Thursday. “We want to caution parents, caregivers and healthcare providers about these products when used for the prevention or treatment of disease, as they have not undergone the agency’s rigorous premarket process to evaluate their safety and effectiveness for these uses,” he added.

A woman shops for yogurt, a food commonly associated with good gut bacteria known as probiotics. Olga Maltseva/AFP/Getty Images

The American Academy of Pediatrics issued guidelines on probiotics, saying due to the “lack of FDA-regulated pharmaceutical grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants, particularly those with a birth weight of less than [2.2 pounds].”

Despite the FDA’s and American Academy of Pediatrics’s claims, a survey of 106 trials involving some 26,000 infants, published in JAMA Pediatrics several weeks ago, found that probiotics with several strains of bacteria can reduce infant deaths overall. The survey also found that it can reduce inflammation of the intestines caused by necrotizing enterocolitis.

Probiotics are a type of bacteria that are consumed for health benefits and are found in yogurt, kefir, and supplements. Evivo with MCT Oil contains only one strain of bacteria, Infinant Health has said.

Several weeks ago, Infinant Health told CBS News that it is “cooperating with FDA’s ongoing investigation” and has agreed to stop distributing the Evivo with MCT Oil products.

In a May news release, Infinant Health said its products are popular among parents and are used in hospitals around the United States, including in neonatal intensive care units.

The product is “clinically shown to work with breast milk,” the company says on its website, adding that “Evivo helps establish a healthy gut microbiome to support healthy digestive and immune function.”

In a statement to news outlets this week, a spokesperson for Abbott said that “this issue pertains to a single probiotic additive for formula called Similac Probiotic Tri-Blend, which is used by fewer than 200 hospitals.”

“Importantly, this does not apply to any of Abbott’s infant formula products available at retail, and parents and caregivers can continue to find and use Similac infant formulas nationwide,” Abbott’s statement said. “This Warning Letter is not related to any manufacturing quality issue. This product has been used for the past several years and has had a strong safety profile.”

In September, meanwhile, the FDA sent out a public warning to Infinant Health and described Evivo with MCT Oil as “an unapproved new drug and unlicensed biological product.”

“Because their gastrointestinal system is not fully matured, preterm infants have more permeable intestinal linings, often referred to as ‘leaky guts,’ and motility problems, which can lead to opportunistic infections and sepsis when ingesting living microorganisms,” the agency said. “The current published literature does not show consensus among qualified experts that the use of living microorganisms in preterm infants is safe.”