Abbott Laboratories has announced that it will stop selling all infant formula probiotics after the FDA reported that an infant died.
Abbott said it will stop selling Similac Tri-Blend Infant Formula on October 26, after the FDA issued a warning about the risk of deadly infections, especially in hospitalized premature infants.
The FDA said it is concerned because probiotics may contain live bacteria or fungi such as yeast, which may cause deadly invasive infections in infants.
The warning was prompted by the death of a premature infant who was given a probiotic — Evivo with MCT Oil (Infinant Health) — as part of in-hospital care. Tragically, the infant developed a severe infection caused by bacteria in the probiotics and subsequently died.
The agency also sent a Letter to Healthcare Providers, warning that some unapproved, unlicensed probiotics are advertised to reduce the risk of Necrotizing Enterocolitis (NEC).
NEC is a devastating disease that occurs primarily in preterm infants, when dangerous bacteria ruptures the walls of the intestines.
In recent years, Abbott has been hit by a growing number of lawsuits involving babies who developed NEC after being fed infant formula.
These lawsuits have raised concerns about the aggressive marketing of cow’s milk-based formula as an effective alternative to human breastmilk, despite the increased risk of deadly side effects like NEC.