U.S. Food and Drug Administration Warns Against Using Probiotic Products for Preterm Infants
The U.S. Food and Drug Administration (FDA) has issued a warning regarding the use of probiotic products for preterm infants due to potential health risks. This announcement comes after the agency revealed its investigation into the death of a preterm baby who had been given a probiotic while in the hospital.
Probiotic products, which contain live organisms like bacteria or yeast and are often marketed as food or dietary supplements, pose a grave risk to preterm infants. The bacteria or yeast in these products can cause invasive and potentially fatal diseases or infections.
In response to these risks, the FDA has sent a letter to healthcare providers to alert them and has also issued two warning letters to companies illegally selling these products. The agency is concerned about adverse events in infants following the use of probiotics and emphasizes that these products have not undergone the FDA’s rigorous evaluation process for safety, effectiveness, and quality for medical uses.
The FDA has reported more than two dozen adverse events associated with probiotic products in the United States since 2018. The latest death followed the use of Evivo with MCT Oil, a probiotic manufactured by Infinant Health. This product has now been recalled. Infinant Health and Abbott Laboratories, the manufacturer of Similac Probiotic Tri-Blend, both received warning letters from the FDA.
Abbott Laboratories has agreed to discontinue the sales of its product and is cooperating with the FDA to take additional corrective actions. The FDA emphasizes that no probiotics have been approved for use as drugs or biological products in babies. Unlike other medications regulated by the FDA, probiotics are sold as dietary supplements, allowing them to bypass the agency’s rigorous manufacturing and testing standards.
The FDA’s warning serves as a reminder to parents, caregivers, and healthcare providers to exercise caution when it comes to using probiotic products, especially for preterm infants. The agency is committed to ensuring the safety and effectiveness of medical products and urges comprehensive evaluation before their use.
The FDA’s statement underscores the importance of proper regulation and evaluation processes to protect the health and well-being of vulnerable populations.