Probiotics can work magic in our digestive system. They’re designed to balance and to inject good bacteria into our gut. The gut then affects and influences the health of the rest of the body. Therefore, probiotics can be very beneficial for adults.
But that’s not necessarily the case for infant bodies. Now, the Food and Drug Administration is warning parents that probiotics can be extremely risky for young children. Sadly, they’ve already been linked to one infant death.
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An infant's death was linked to probiotics this year.
Earlier this year, an infant’s death was connected to the use of probiotics, NBC News reported. Although this has been the most severe case, there have been more than two dozen incidents with infants having adverse reactions to probiotics.
Now, the FDA is looking to see if other cases of infant sickness also could have been related to probiotics. The agency has not approved probiotics for infants of any age. Yet, some products are sold illegally to treat infants who were born preterm, the FDA said.
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The FDA issued a statement to medical providers.
Because probiotics are not drugs but dietary supplements, the FDA doesn’t review them for safety or effectiveness. The FDA now is taking a more proactive approach in keeping babies safe. Last month, the agency sent a letter to health care providers warning them about probiotics in preterm infants, citing the death of one infant who had been given a probiotic product called Evivo, produced by Infinant Health.
The company that produced the probiotics has not issued a statement.
The baby, who was still in the hospital after birth, developed sepsis and subsequently died. The letter did not detail where the death occurred, according to NBC News. Infinant Health has not spoken about the death. The problem, however, is larger than Infinant.
The FDA also warned about Abbott’s Laboratories Similac Probiotic Tri-Blend, which was being sold in hospitals. It is unclear whether Abbott’s product had any adverse effects in babies. Still, the company agreed to discontinue sales and is working with the FDA to “take additional corrective actions.”
About 10% of infants in the NICU receive these supplements.
The FDA has previously warned against probiotics, citing the issue in medical literature. The latest statement is a reiteration of that warning.
"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," Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, shared in a statement.
The American Academy of Pediatrics, which also doesn’t recommend the use of probiotics in preterm infants, noted that about 10% of these infants receive these supplements during their stay in the neonatal intensive care unit, NBC News reported.
*Disclaimer: The advice on CafeMom.com is not a substitute for consultation with a medical professional or treatment for a specific condition. You should not use this information to diagnose or treat a health problem without consulting a qualified professional. Please contact your health-care provider with questions and concerns.
