The death of a one-week formula fed infant, Natan, born March 11, in Belgium raises important questions about the safety of breastmilk substitutes. Natan’s untimely death has again focused on the health risks of formula feeding. Born healthy with an excellent AGPAR score, Natan had been fed Nestlé Beba 1 powdered infant formula during his hospital stay in Aalst. Soon after hospital discharge, his fifth day (this is the normal hospital stay in Belgium), he became ill and his parents admitted him during the night to the University Hospital in Ghent. Soon after on the 16th of March he died of meningitis.

The family contacted the Belgian IBFAN group when they became aware that pathogenic bacteria, Enterobacter sakazakii, caused the death of their baby. This highly virulent bacterium can survive the usual heat treatments in the production of powdered infant formulas.

Shortly after, on April 12, the U.S. Food and Drug Administration (FDA) issued a communiqué warning that E. sakazakii linked to the use of powdered formula can be the cause of invasive infections with a high mortality outcome in neonates.

The FDA warning was prompted by the death a year earlier of an infant who had been hospitalized and fed commercial powdered infant formula that was found to be infected with E. sakazakii.

A subsequent investigation to determine the extent of infection with E. sakazakii triggered the FDA warning. The surveillance study found that of 49 cases studied, 10 were identified with positive E. sakazakii cultures. A cohort study was performed to determine the possible risk factors for the infection. Medical records were reviewed to assess risk factors such as gestational age, birth weight, medications, type and mode of feeding. Results of the risk  nalysis determined that only the use of Portagen Mead Johnson powdered formula was associated with the E. sakazakii infections. All case patients had received the contaminated  powdered formula.

Stating that, “Clinicians should be aware that powdered formulas are not sterile products and might contain opportunistic bacterial pathogens such as those in the family Enterobacteriacae, including E. sakazakii,” the FDA warning notes, “These products are commonly used at many hospitals. A recent survey indicated that of 16 responding facilities, nine used powdered formulas.”

In a letter on its website, the FDA reports that it found 14 per cent of tins of powdered formula tested to be contaminated with the E. sakazakii. The letter also mentioned a “Belgian case” dating back to 1998 when two infants died and a number of infants became ill.

It took nearly seven weeks for the Belgian Federal Agency for Food Safety to ask Nestlé to recall its Beba 1 product – as a “precautionary measure.” The surrounding publicity revealed that the parents of the previous two deaths in 1998 had never been informed of the cause of death.

The contaminated batch of Nestlé Beba 1 was manufactured by Nestlé Germany Kapeln. Nestlé claims the product was only distributed to Belgium and Switzerland, but is also being recalled from Luxembourg (although no information has been provided to consumers there).

We wonder how many of these cases go undetected and how many are not traced back to contaminated formula. What happens in countries where rigorous microbial testing and diagnosis is unaffordable. How many infants have died of contaminated formula products. As one European lactation consultant noted, “the formula comes already with the contaminating bacteria.”

The contamination risks demonstrated by the presence of E. sakazakii in powdered infant formulas highlight the critical need for adequate product labeling, and strict enforcement of product regulations. Precautionary principles, adequate surveillance and monitoring systems with immediate, publicly announced, mandatory recalls are essential for health protection. Importantly, the seriousness of E. sakazakii contamination demonstrates the consequences of no code compliance.

In Canada, Nestlé mails its unsolicited powdered formulas accompanied by misleading health claims to pregnant women and new mothers. This practice of promotion and idealization of infant formula products must stop. Instead truthful and independent information about infant feeding is needed so parents and their newborns can avoid the tragedy of E. sakazakii babies.

In Canada

Although there have been no recalls for infant formulas contaminated with E. sakazakii, in Canada, Health Canada will be issuing a Health Provisional Advisory Letter intended for neonatal units, hospitals and health care workers, to warn that formulas are not sterile products and that prescribed procedures must be strictly followed.

 

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