An investigation was launched at an undisclosed hospital after the death of a baby who was given Evivo with MCT Oil, a probiotic made by California-based Infinant Health. Genomic sequencing showed that the baby died of sepsis caused by a bacterium found in Evivo. The product has been recalled.
The FDA warned that no probiotic has been approved for use as a drug or biological product in babies. The American Academy of Pediatrics has also warned against the use of probiotics for preterm infants.
“Healthcare providers should be aware that these products have not undergone the FDA’s rigorous premarket review evaluation for safety and effectiveness, nor have they been evaluated for compliance with the agency’s rigorous manufacturing and testing standards for drugs and biological products, including testing for extraneous organisms,” the warning letter said.
Evivo was used by healthcare professionals in hospital settings, including neonatal care, the company told CBS News on Oct. 2. A 2021 report suggested 1 in 10 “extremely low gestational age” infants were being given probiotics by hospitals.
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