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amid rising outbreak linked to infant botulism Child FORMULAat least 15 children State and federal officials said Tuesday that 12 states have fallen ill with the outbreak.
Organic infant formula manufacturer Bayheart has recalled all of its products sold United States of America,
No deaths have been reported in the outbreak, which began in mid-August.
Bayheart officials said Guardian And caregivers who have this formula in their homes should “immediately stop using the product and dispose of it.”
fda is investigating 84 cases of infant botulism found since August. Of those, 36 consumed infant formula — more than a third of them Bayheart formula, the agency said in a statement.
Here’s what to know about the outbreak and infant botulism:
outbreak begins
Since the outbreak began, it has sickened children ages 2 weeks to 5 months. babies was hospitalized after consuming Bayheart powdered formula, according to the U.S. Centers for Disease Control and Prevention.
California Officials confirmed that a sample of an opened container of Bayheart baby formula fed to an ill infant contained Type The bacteria that cause the toxin associated with the outbreak. Tests to confirm contamination involve injecting mice with cultured bacteria and then waiting for four days to see if they get sick.
“These rats got sick really quickly,” Dr. Erica Pan, CDPH director and state public health officer, said in an interview.
Bayheart officials said they recalled their products “in close cooperation” with the U.S. Food and Drug Administration, “despite the fact that none of the discontinued Bayheart products” tested positive for disease-causing bacteria.
The FDA is investigating 84 cases of infant botulism discovered since August. Of those, 36 consumed infant formula — more than a third of them Bayheart formula, the agency said in a statement.
The FDA said, “This information suggests that Bayheart brand formula is disproportionately represented among sick infants in this outbreak, particularly given that Bayheart represents an estimated 1% of all infant formula sales in the United States.”
causes of infant botulism
Infant botulism usually affects fewer than 200 infants each year in the US. It is caused by a type of bacteria that produces a toxin in the large intestine. This bacteria is spread through hardy spores present in the environment and can cause serious illness, including paralysis.
Infants are particularly vulnerable to infection because their gut microbiome is not developed enough to prevent spores from germinating and producing a toxin. They can become sick by coming into contact with spores in dust, dirt or water, or by eating contaminated honey.
symptoms It may take several weeks to develop and may include poor feeding, loss of head control, droopy eyelids, and a flat facial expression. Babies may feel “floppy” and have trouble swallowing or breathing.
Dr. Steven Abrams, a nutritionist at the University of Texas, said no known outbreaks of infant botulism linked to powdered formula have been previously confirmed.
infant botulism treatment
The only treatment is known as BabyBIG, an IV drug made from collected blood plasma of adults immunized against botulism. California’s Infant Botulism Treatment and Prevention Program developed the product and is the sole source worldwide.
BabyBIG works to reduce the length of hospital stay and severity of illness in infants with botulism. Because infection can affect the ability to breathe, babies often need to be placed on a ventilator.
All children in the Bayheart outbreak have received the drug, the CDC said. Pan said the treatment is given in vials that cost $69,300.
Potential impact on US formula supply
The risk of infant formula shortages is very low because Bayheart represents a small portion of the market. This is a far cry from the crises of late 2021 and 2022, when four infants became ill from a different germ after consuming formula made by Abbott Nutrition. Two children died. No direct link was found between Abbott products and infections caused by a different germ, Cronobacter sakazakii, but FDA officials closed the company’s Michigan plant after contamination and other problems were discovered.
Abbott recalled top brands of infant formula, triggering a nationwide shortage that lasted for months.
In 2022, Bayheart recalled five batches of infant formula after a sample at the company’s packaging plant tested positive for Cronobacter sakazakii. In 2023, the FDA sent the company a warning letter detailing “areas where corrective action is still needed.”
Reviewing Infant Formula Ingredients
Federal health officials have vowed to overhaul the US food supply and are taking a fresh look at infant formula.
Health Secretary Robert F. Kennedy Jr. has directed the FDA to review the nutrients and other ingredients in infant formula, which fills the bottles of millions of American babies.
The effort, dubbed “Operation Stork Speed,” is the first deep look at the material since 1998.
FDA officials are reviewing comments from industry, health experts and the public to determine next steps.