Abbott Ends Sales of Probiotic Infant Formula After FDA Warning, Child’s Death

Decision came after FDA determined Similac Probiotic Tri-Blend is an unadulterated drug product, which could put preterm infants’ lives at risk.

Abbott Laboratories has announced it is ending sales of all infant formula probiotic products, following a warning by federal regulators that was prompted by the death of at least one child.

The decision to stop sales of its Similac Tri-Blend infant formula products came on October 26, the same day the U.S. Food and Drug Administration (FDA) issued an infant formula probiotics warning, indicating the products contain live organisms, such as yeast or bacteria, which may be dangerous to preterm infants.

The FDA sent a warning letter to Abbott Laboratories the day before, indicating that Similac Probiotic Tri-Blend contained Bifidobacterium infantitis and Streptococcus thermophilus.

According to the agency, B. infantitis is an unsafe food additive. The FDA also warned that S. thermophilus is a new, unproven, dietary ingredient “for which there is inadequate information to provide reasonable assurance that such an ingredient does not present a significant or unreasonable risk of illness or injury, when used in preterm infants.”

The use of these ingredients, and the way Abbott has marketed the infant formula makes it Similac Probiotic Tri-Blend an unadulterated drug product, the FDA determined.

Infant Formula Probiotics Put Preterm Children At Risk: FDA

The warning letter and market removal came about a month after the FDA issued a letter to healthcare providers, warning that at least one preterm infant has died after receiving probiotic formula and developing sepsis.

The agency indicates Abbott’s sales representatives gave doctors and healthcare professionals marketing handouts, which claimed that the product could reduce all-cause mortality, late-onset sepsis, and reduces the risk of necrotizing enterocolitis (NEC); a potentially deadly gastrointestinal complication that can lead to severe injury, disability, and death for newborns.

“The FDA is concerned as these products can be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preterm infants in hospital settings, such as to reduce the risk of necrotizing enterocolitis,” the most recent FDA warning states. “Preterm infants who are administered a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics.”

Similac Infant Formula Lawsuits

The Similac Tri-Blend infant formula recall also comes amid continuing concerns about Abbott’s marketing of cow’s milk-based formula products for preterm infants, which has been linked to a risk of NEC, and resulted in a number of Similac infant formula NEC lawsuits being filed by families of children who have developed this devastating condition.

NEC is a devastating gastrointestinal disease, which primarily impacts premature babies, occurring when harmful bacteria breaches the walls of the intestines, causing portions of the tissue to become inflamed or die. The condition often results in the need for emergency surgery while the baby is still in the NICU, and many infants do not survive NEC.

Over the past few years, a number of prominent health organizations have raised concerns about the aggressive marketing of Similac, Enfamil and other formula products, which promote the cow’s milk-based formula as an equally effective alternative to a mother’s breast milk.

False and misleading statements have been blamed for driving many families away from breastfeeding, and suppressed demand for human donor milk, while also increasing the incidence of NEC from infant formula.

These allegations have been mirrored in a number of Similac lawsuits and Enfamil lawsuits filed in recent years.

Each of the infant formula lawsuits over NEC raise similar allegations, indicating that manufacturers of cow’s milk-based infant formula and human milk fortifier specifically marketing products for use by preterm newborns, without providing warnings to hospitals, doctors or families. However, as parents and hospitals now better understand the risk information that manufacturers have known for some time, there has been increasing adoption of human donor milk and increased efforts to encourage breast feeding.