FDA, CDC say bacterial infections not linked to infant formula
Updated to reflect new information released by the FDA and CDC on Friday, Dec. 30.
A joint statement released Friday by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) says their investigation has found no evidence linking four recent cases of Cronobacter infection in infants to Enfamil or any other infant formula.
According to the statement, there is no evidence that four recent cases of Cronobacter infection in infants in four states - Missouri, Illinois, Florida, and Oklahoma - are related. The infants in Missouri and Florida died as a result of their infection, while the infants in Illinois and Oklahoma have survived.
The statement says there is no need for a recall of infant formula and that parents may continue to use powdered infant formula following the manufacturer’s directions on the printed label.
The ongoing investigation includes laboratory testing of various types of infant formula, the water used in preparing the formula, and when available, clinical samples from the infants.
More from Friday's FDA-CDC statement:
"The ongoing investigation includes laboratory testing of various types and brands of powdered infant formula, nursery water and, when available, clinical samples from the infants. The investigation also includes the inspection of manufacturing facilities for infant formula and nursery water.
The following results have been confirmed from completed laboratory tests, although additional lab results are pending release:
- CDC’s laboratory conducted DNA fingerprinting of the bacteria from two recent cases of Cronobacter infection in infants (Missouri and Illinois). The results show that the Cronobacter bacteria differ genetically, suggesting that they are not related. (Bacteria from cases in Oklahoma and Florida are not available for analysis.)
- CDC laboratory tests of samples provided by the Missouri Department of Health and Senior Services found Cronobacter bacteria in an opened container of infant formula, an opened bottle of nursery water and prepared infant formula. It is unclear how the contamination occurred.
- The FDA tested factory sealed containers of powdered infant formula and nursery water with the same lot numbers as the opened containers collected from Missouri and no Cronobacter bacteria were found."
Mo. Department of Health: Discard 12.5 oz. cans of Enfamil PREMIUM Newborn powder with lot number ZP1K7G
Il. Department of Health: Boil water and make up fresh formula for every feeding
Health authorities are investigating a possible link between the death of a Missouri newborn and the formula powder he was fed. Now, they say another baby in the region may have contracted the same rare bacterial infection from formula.
Ten-day-old Avery Cornett died Sunday after he was fed Enfamil PREMIUM Newborn powder bought at a Wal-Mart in the southern Missouri town of Lebanon.
Wal-Mart subsequently pulled a batch of the infant formula from more than 3,000 of its stores.
The Illinois Department of Health (IDHP) said in a statement on Thursday that an Illinois infant also contracted the Cronobacter (formerly Enterobacter) sakazakii bacterial infection earlier this month. The infant, who has recovered, was fed several different types of infant formula. The Illinois infant was treated at a Missouri hospital.
And health officials are also more closely investigating the death on Thursday of a second Illinois infant, four-week-old Ivyionna Ayne Marie Pinnix of Granite City. A report from the Madison County coroners' office says an autopsy performed Thursday found no overt signs of injury to the infant, who was born four weeks premature.
The report continues:
"Further consideration is being given with consultation being sought to the possibility of congenital or developmental defects playing a role in the sudden demise of this infant. In view of recent public health reports concerning the possibility of infant formula contamination, blood culture testing has been initiated, but the autopsy examination revealed no physical manifestations of an infectious or communicable disease process."
The Missouri Department of Health is recommending that customers who purchased Enfamil PREMIUM Newborn powder in 12.5 oz. cans with lot number ZP1K7G printed on the bottom discard the product or return it to the store where it was purchased. Wal-Mart is offering to refund or exchange the product at its stores.
On Friday, officials at Supervalu Inc., Walgreen Co., Kroger Co. and Safeway said they have also removed cans of Enfamil Newborn with the lot number ZP1K7G from various stores across the country.
The product manufacturer, Mead Johnson, says there is no official government recall on Enfamil Newborn or any of its other infant formulas at this time. The company says it tests all of its infant powdered products for C. sakazakii prior to shipment.
The U.S. Food and Drug Administration has collected multiple brands of infant formula and water from the homes of the two infants with confirmed C. sakazakii infections and is testing them for the bacterium. The agency is also testing formula from sealed containers collected from from area stores.
The U.S. Centers for Disease Control and Prevention is participating in the investigation.
The Illinois Department of Health recommends the following precautions to reduce the risk of infection in infants:
- Wash hands, forearms and fingernails thoroughly before handling any feeding materials or preparing formula.
- All bottles, nipples, caps and rings should be washed in hot, soapy water with thorough rinsing.
- Before use, powdered formula should be kept dry in an airtight container with a firm cap or lid and stored in a cool, dark area. Make sure the expiration date has not passed.
- During formula preparation, bring water to a bubbling boil for two minutes and allow the water to cool before mixing.
- Do not use a microwave oven to warm the formula.
- Formula should be prepared in small amounts immediately before feeding time to minimize the need for storing reconstituted formula.
- Reconstituted formula should not be stored at room temperature for more than one hour or more than four hours in the refrigerator after preparation.
- Throw out any formula left in a bottle after feeding.
Additional information on best practices in preparing infant formula can be found here:
Illinois Department of Human Services: http://www.dhs.state.il.us/page.aspx?item=32190
World Health Organization (WHO):http://www.fao.org/ag/agn/agns/files/pif_guidelines.pdf