By Stephanie Armour and Michelle Fay Cortez - Dec 23, 2011 12:01 PM GMT+0700
A rush is on to determine if infant formula triggered a bacterial infection that killed one newborn and sickened another baby who were both treated at Missouri hospitals.
Regulators are testing samples of powdered formula, along with the water used to prepare the products and the clothes the children wore, according to the U.S. Food and Drug Administration. Mead Johnson Nutrition Co. (MJN) plunged 10 percent yesterday after Wal-Mart Stores Inc. (WMT) pulled its Enfamil Newborn formula from shelves after it was determined the infant who died was given that brand.
The other formula wasn’t identified by health officials. Both babies tested positive for Cronobacter, an environmental bacteria that can cause serious illness or death. If the formula itself is to blame, it would probably spur a national recall, said Siobhan DeLancey, an FDA spokeswoman.
“We are trying to figure out whether it came from the food,” DeLancey said by telephone. “We take these into local labs and test them. We expect first results back next week.”
U.S. health officials probe about four to six such cases a year, she said.
Neither Wal-Mart, based in Bentonville, Arkansas, nor Mead Johnson, in Glenview, Illinois, provided the number of cans removed from shelves. The number is in the thousands, and about half of Wal-Mart’s stores carry the formula, said Chris Perille, a spokesman for Mead Johnson.
Refunds
Customers can return the withdrawn formula for a refund or exchange, said Dianna Gee, a spokeswoman for Wal-Mart, the world’s biggest retailer. The company had 3,856 stores in the U.S. as of Nov. 30, according to its website.
The Missouri Department of Public Health and Senior Services on Dec. 19 issued a health alert on two babies infected with the bacteria within the last month, according to the agency’s website. The department didn’t say if the second infant, who lived out-of-state but was treated in Missouri, used the Mead Johnson product.
That question is “a big, fat unknown,” DeLancey said.
Cronobacter is part of a family of a family of microorganisms called Enterobacter sakazakii that has a fatality rate of 40 percent to 80 percent in infants, according to Marler Clark, a Seattle-based law firm that focuses on foodborne illness litigation.
Purchase at Wal-Mart
The dead child’s family “purchased the formula at a Wal- Mart store, and ‘out of an abundance of caution’ Wal-Mart decided to voluntarily ‘pull & hold’ the same size cans (12.5 oz.) of Enfamil Newborn from the same batch code until the investigation is completed,” Perille said in an e-mail.
The batch consumed by the infant who died tested negative when it was made and packaged, and the results were reconfirmed after the news, he said.
“Outbreaks of this particular bacteria are typically linked to powdered infant formula, but it is unclear at this point where along the chain the contamination occurred or if the formula is the cause altogether,” Edward Aaron, an analyst with RBC Capital Markets in Denver, wrote in a research note today.
Finding a common source may be daunting, in part because memories of what was purchased can be faulty, said Bill Marler, a food-safety lawyer in Seattle. “They’re trying to ask people who are going through a trauma what they bought,” he said.
Wal-Mart learned of the death Dec. 18, Gee said. The company immediately removed the product from the Lebanon store and the next day notified more than 3,000 stores in 49 states.
Wal-Mart has had “nearly 100 percent compliance” from its stores, she said.
‘Products Could Return’
“Since we knew there was an active investigation by the Missouri Department of Health, we decided it was best to pull the product until the investigation is complete,” Gee wrote in an e-mail. “The products could be returned at a later date.”
While it’s premature for parents to change what they feed their infants, it’s important to remind them to prepare formula properly, said Lorry Rubin, chief of pediatric infectious diseases at Cohen Children’s Medical Center of New York.
Glassware and bottles should be cleaned and sterilized, and the water should be boiled and cooled before it is added to powered formula, he said. Any extra prepared formula should be immediately refrigerated and used within 24 hours, he said.
Bacteria from the Cronobacter family are known to have contaminated infant formula, he said in a telephone interview. The strains are similar to the bacteria humans carry in their gut and typically don’t cause significant concern, he said.
“The powder formula isn’t necessarily a sterile product, but taking precautions, even if there is a small amount of bacteria in there, it shouldn’t be enough to harm the baby,” Rubin said. “If you re-warm it or make improperly, the bacteria can multiply and you have a higher risk of getting ill.”
Detective Work
Public-health officials will have to determine if the fingerprint of the bacteria is the same in both children, which would indicate a common source of contagion, said Dave Theno, chief executive officer of Gray Dog Partners Inc., a food-safety consultant in Del Mar, California.
“The questions are: Are they made in the same plant, are they made by the same manufacturer?” Theno said in an interview.
The Enfa brands, which include Enfamil, accounted for 79 percent of Mead Johnson’s $3.14 billion in 2010 revenue and were the world’s lead brand franchise in pediatric nutrition based on retail sales, the company said in a February filing. About 12 percent of Mead Johnson’s sales come from Wal-Mart, according to data compiled by Bloomberg.
Several cases of foodborne illness from infant formula are reported each year to the Centers for Disease Control and Prevention, Lola Scott Russell, a spokeswoman, said in an e- mail.
Last year, Abbott Laboratories recalled Similac-brand powder infant formulas distributed in the U.S., Puerto Rico, Guam and some Caribbean nations because of possible insect contamination.
To contact the reporters on this story: Stephanie Armour in Washington at sarmour@bloomberg.net; Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
Posts
No comments:
Post a Comment