Avoid Giving Probiotics to Preemie Babies
Medically reviewed by Drugs.com.
By Physician’s Briefing Staff HealthDay Reporter
FRIDAY, Oct. 27, 2023 -- Federal regulators have sent warning letters to two companies for illegally selling probiotic products for use in preterm infants. The U.S. Food and Drug Administration also sent a letter to health care providers warning of the risks.
Probiotic products may be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preemies in hospitals, such as necrotizing enterocolitis. Those young babies who are given a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast in the probiotics, the FDA said.
Certain products have contributed to invasive disease in hospitalized babies, including one death this year. They have been linked to more than two dozen other reported adverse events nationwide since 2018, according to the FDA.
No probiotic product is approved by the FDA for infants of any age. Products sold for this purpose have not gone through FDA safety evaluations or been checked for compliance with the agency’s rigorous manufacturing and testing standards. These products would need an approved Biologics License Application. Without the approval, health care providers who administer products containing live bacteria or yeast to treat or prevent disease are required to submit an Investigational New Drug application to the FDA.
A warning letter was sent to Abbott Laboratories on Oct. 24 for its Similac Probiotic Tri-Blend, which contains B. infantis (Bb-02), S. thermophilus (TH-4), and B. lactis (BB-12). Abbott has agreed to stop selling this product. The other warning letter was sent to Infinant Health, Inc. (formerly Evolve BioSystems Inc.) regarding its probiotic product, Evivo with MCT Oil. It has been voluntarily recalled and is no longer available in the United States.
"Protecting public health, especially of the most vulnerable populations such as preterm infants, is one of the highest priorities for the FDA," James Jones, deputy commissioner for human foods at the FDA, said in an agency news release. "We are encouraging all involved in the care of preterm infants -- including parents, caregivers, and health care providers -- to be aware of the possible risks associated with the administration of probiotic products to preterm infants in hospital settings."
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted October 2023
Read this next
Nutritional Interventions for Moderate- to Late-Preterm Infants Show No Effect
MONDAY, April 29, 2024 -- Routine nutrition interventions to support moderate- to late-preterm infants until full nutrition with mother’s breast milk does not impact...
Antenatal Corticosteroids Do Not Negatively Impact Offspring
FRIDAY, April 26, 2024 -- Administration of antenatal corticosteroids to persons at risk for late preterm delivery is not associated with adverse childhood neurodevelopmental...
Occurrence of Low-Birth-Weight Babies Heightened in Active-Duty Servicewomen
THURSDAY, April 25, 2024 -- Active-duty servicewomen in the United States appear to have an increased occurrence of low-birth-weight babies compared with nonservice women...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.