FDA Warns of Potential Dangers of Probiotics for Preterm Infants

The Food and Drug Administration (FDA) has issued a warning about the potential dangers of probiotics for preterm infants. The agency said that these products, which contain live organisms such as bacteria or yeast, can cause “invasive, potentially fatal disease, or infection” in very young babies.

The FDA’s warning comes weeks after the agency announced it was investigating the death of a preterm baby that was given a probiotic in the hospital, which ultimately caused the child’s death. Since 2018, there have been more than two dozen adverse events in infants linked to the products, and the agency is investigating whether probiotics have contributed to other cases in babies.

Probiotics are commonly used as dietary supplements in the U.S., but the FDA does not regulate them as drugs. Some products, however, are illegally sold to treat diseases in preterm infants in hospital settings, the FDA said.

In response to the risks associated with probiotics, the FDA has sent a letter to health care providers about the dangers of these products. The agency is also urging parents and caregivers to talk to their health care provider before giving probiotics to preterm infants.

The FDA is continuing to investigate the safety of probiotics and is encouraging health care providers to report any adverse events associated with the products. The agency is also encouraging parents and caregivers to report any adverse events associated with probiotics to the FDA’s MedWatch Adverse Event Reporting program.