FDA Issues Alert on Potential Risks of Giving Probiotics to Preterm Infants Following Death and Injury

The U.S. Food and Drug Administration (FDA) is cautioning healthcare providers and the public about injuries and a reported death in premature infants who received probiotic products in the hospital.

Probiotic products, which are supplements containing live organisms such as bacteria or yeast, can potentially lead to invasive and fatal infections or diseases, according to the FDA.

Since 2018, there have been more than two dozen reports of injuries and one death that may be associated with these supplements. The FDA is currently investigating additional reports of injuries and deaths.

The FDA emphasizes that no probiotic products have been approved for use as a drug or treatment for babies.

Two companies, including Abbott Laboratories, have received warning letters for illegally marketing probiotic products. Abbott Laboratories has stopped sales of its Similac Probiotic Tri-Blend product and is cooperating with the FDA on corrective actions.

In September, the FDA reported that a probiotic made by Infinant Health was linked to the death of a premature infant. The bacterium that caused sepsis in the infant was found to be the same as the one found in the probiotic product.

Probiotic supplements are sometimes used to prevent necrotizing enterocolitis, a dangerous infection that affects premature infants and can result in death.

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AP Health Writer Matthew Perrone in Washington contributed to this report.

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