Health Law

E. sakazakii infection from powdered infant formula: Know the risks

By Marler Clark

In early May of 2007, the Center for Acute Disease Epidemiology (CADE) of the Iowa Department of Public Health (IDPH) was notified that a two-week-old premature infant had been diagnosed with Enterobacter sakazakii (E. sakazakii) infection. The child, a twin, was born at a low birth weight, and was fed a mixture of powdered infant formula and breast milk while in the NICU. Records indicated that the baby was fed the powdered infant formula and breast milk mixture three times the day he became ill with symptoms of E. sakazakii infection. By that evening, he had developed a faster than normal heart rate. Lab tests confirmed E. sakazakii infection within 48 hours.

The infant remained hospitalized for nearly five months, suffering multiple complications of E. sakazakii infection – seizures, respiratory distress, diabetes insipidus, and others. He underwent multiple surgeries for digestive and respiratory management, but remains on a ventilator today. The E. sakazakii infection resulted in significant brain damage, and an early assessment of the child's brain function revealed that it was doubtful he would ever be able to understand, talk, think, or gain motor function. In mid-2008, an MRI of the child's brain revealed that he is in a permanent vegetative state, and he remains in a care facility, as his parents are unable to care for him at their home. 

In 2002, the FDA issued a letter to healthcare providers regarding E. sakazakii infection associated with powdered infant formula in neonatal intensive care units. In it, FDA wrote:

As background information for health professionals, FDA wants to point out that powdered infant formulas are not commercially sterile products. Powdered milk-based infant formulas are heat-treated during processing, but unlike liquid formula products they are not subjected to high temperatures for sufficient time to make the final packaged product commercially sterile. FDA has noted that infant formulas nutritionally designed for consumption by premature or low birth weight infants are available only in commercially sterile liquid form. However, so-called "transition" infant formulas that are generally used for premature or low birth weight infants after hospital discharge are available in both non-commercially sterile powder form and commercially sterile liquid form. Some other specialty infant formulas are only available in powder form.

The FDA has become increasingly aware that a substantial percentage of premature neonates in neonatal intensive care units are being fed non-commercially sterile dry infant formula. In light of the epidemiological findings and the fact that powdered infant formulas are not commercially sterile products, FDA recommends that powdered infant formulas not be used in neonatal intensive care settings unless there is no alternative available.

Although healthcare providers should be aware of the risks of serving powdered infant formula to newborns – especially those hospitalized in NICU – this family's story is only one of many. The National Healthy Mothers, Healthy Babies Coalition website and others that help parents prepare for the birth of their child should include information about this virulent pathogen that can be present in powdered infant formula. In 2004, the World Health Organization published information regarding E. sakazakii contamination of powdered infant formula. That information, along with any information from the FDA and CDC, should be disseminated to expecting parents. 

Full post as published by Food Poison Blog on July 16, 2009 (boomark / email).