Injuries and at least one death have been reported in premature newborns who received probiotic supplements in hospitals, according to a warning from the U.S. Food and Drug Administration to medical professionals and the general public.
The products can cause invasive, potentially fatal illnesses or diseases since they include live organisms like bacteria or yeast and supplement regular meals.
The supplements may be responsible for one fatality this year and more than twenty reports of injury since 2018, according to a statement from FDA authorities. The organization declared that it is also looking into other injury and fatality complaints.
According to the FDA, no probiotic products have been authorized as a medicine or treatment for infants.
The FDA sent warning letters to two businesses, including Abbott Laboratories, which was at the center of a recall and nationwide shortage of powdered infant formula last year and was accused of improperly marketing the probiotic products.
The FDA said that following a letter received on Tuesday, the Illinois company agreed to stop selling its Similac Probiotic Tri-Blend product and cooperate with the agency on additional corrective measures.
Fewer than 200 hospitals used the items, according to a statement from Abbott officials, and they had no connection to the commercially available Similac powdered infant formula.
The probiotic Evivo with MCT Oil, manufactured by Infinant Health in Norwalk, Connecticut, was blamed by FDA officials in September for the death of a premature baby this year.
The sepsis-causing bacterium was identified by genetic sequencing to be the same germ that was present in the probiotic product. Officials from Infinant Health stated in a statement that the company voluntarily recalled and stopped selling the medicine.
It was solely offered for use in healthcare facilities; it has nothing to do with items sold in general merchandise establishments.
Necrotizing enterocolitis, a potentially fatal infection that affects premature infants and causes intestinal tissue to become inflamed and die, may be avoided with probiotic supplements. Up to 9,000 infants can get the illness each year, and it has a 50% mortality rate.