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FDA warns about giving probiotics to preterm babies after infant dies

FDA warns parents not to give their babies probiotics after infant DIED from bacterial infection that led to sepsis when healthcare worker wrongly gave supplement

  • A premature baby died after it was given the probiotic Evivo with MCT Oil
  • No probiotic products have been approved as a drug or treatment for babies
  • READ MORE: Alabama women forced to drive up to 100 MILES for prenatal care 

Babies should not be given probiotics, the US Food and Drug Administration (FDA) has cautioned parents and healthcare providers.

The warning comes following the death of a premature baby after the child was given a probiotic in the hospital, which led them to develop sepsis caused by the species of bacteria in the probiotic.

Probiotics, which contain live bacteria or other microorganisms like yeast to keep the gut healthy, are often used as dietary supplements and are found in yogurt and other fermented foods.

But the products can also lead to invasive, potentially fatal infections or disease, the FDA said.

The baby, which weighed only two pounds at birth, was given Evivo with MCT Oil, a probiotic made by Infinant Health of Norwalk, Connecticut, as part of in-hospital care.

A sign for the US Food and Drug Administration is displayed outside their offices in Silver Spring, Md., Dec. 10, 2020. On Thursday, Oct. 26, 2023, the FDA warned health care providers and the public about injuries and at least one death in premature infants who were given probiotic products in the hospital

The product is formulated to contain the live bacterium Bifidobacterium longum subsp. infantis.

Genetic sequencing confirmed the bacterium that caused sepsis was the same germ found in the probiotic product, the FDA’s letter said.

Probiotic supplements may prevent necrotizing enterocolitis, a dangerous infection affecting premature infants that inflames and kills intestinal tissue. 

The condition affects up to 9,000 infants a year, with a death rate of about 50 percent.

But if probiotic bacteria gets into the bloodstream, it can lead to sepsis.

A baby born prematurely was given Evivo with MCT Oil, a probiotic made by Infinant Health of Norwalk, Connecticut, as part of in-hospital care

One death this year and more than two dozen reports of injuries since 2018 may be tied to the supplements, FDA officials said in a statement. The agency said it is also investigating additional reports of injuries and deaths.

No probiotic products have been approved as a drug or treatment for babies, the FDA said.

Because probiotics are considered dietary supplements, they are not subject to the FDA approval process.

The American Academy of Pediatrics (AAP) does not recommend the use of probiotics in babies, because studies so far have failed to find evidence of their health benefits.

The FDA issued warning letters to two companies accused of illegally marketing the probiotics products, including Abbott Laboratories, which was at the center of a recall and nationwide shortage of powdered infant formula last year. 

After a letter sent Tuesday, the Illinois firm agreed to halt sales of its Similac Probiotic Tri-Blend product and work with the FDA on additional corrective actions, the agency said.

Abbott officials said in a statement the products were used by fewer than 200 hospitals and are not related to Similac powdered infant formulas sold in stores.

Infinant Health officials said in the statement the firm voluntarily recalled and discontinued the product. 

It was sold only for use in hospital settings and is not related to products available in retail stores.

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  • Posted on November 18, 2023