GUT loving probiotics could be ‘extremely risky’ for babies, experts have warned.
The health alert from the US Food and Drug Administration (FDA) comes after one baby developed sepsis and later died after ingesting the supplement.
GettyProbiotic supplements can be used to prevent necrotising enterocolitis[/caption]
Probiotics, which contain healthy bacteria, are often used as dietary supplements in improve gut health.
But the trendy products can also cause “invasive, potentially fatal” infections, the FDA said.
The baby who died was given Evivo with MCT Oil, a probiotic made by Infinant Health of Norwalk, Connecticut, while in hospital.
Probiotic supplements can be used to prevent necrotising enterocolitis, a dangerous infection affecting premature infants that inflames and kills intestinal tissue.
The condition affects up to 9,000 infants a year and kills around 50 per cent of those infected.
But if probiotic bacteria gets into the bloodstream, it can lead to sepsis, a serious condition in which the body overreacts to an infection.
More than two dozen additional reports of injuries since 2018 may be tied to probiotics, the FDA said in a statement.
The agency said it is also investigating additional reports of injuries and deaths.
In the US, no probiotic products have been approved as a drug or treatment.
This is because they are considered to be supplements, not drugs, and the FDA doesn’t review them for their safety or effectiveness.
In the UK, over 40 per cent of all hospitals routinely give probiotics to preterm babies, a recent study found.
But similar to the US, they are not considered medicines, so do not go through the rigorous testing medicines do.
This means no probiotics are approved as a medicine by the Medicines Healthcare Regulatory Agency (MHRA).
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.
In a statement seen by Associated Press (AP), Abbott officials said fewer than 200 hospitals used the products 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.