PHOENIX — At least one child in Arizona has fallen ill in a multistate infant botulism outbreak that has been tied to a brand of infant formula.
At least 15 babies in 12 states have been sickened in the outbreak, which was caused by powdered organic infant formula made by ByHeart, according to the U.S. Food and Drug Administration (FDA).
That is up from 13 cases in 10 states reported Saturday. No deaths have been reported.
On Tuesday, the outbreak led ByHeart to recall all of its Whole Nutrition Infant Formula and Anywhere Pack products sold in the U.S. The company is also advising all parents and caregivers who have the formula in their homes to stop using it and throw it away.
“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” ByHeart Co-Founder and President Mia Funt said in an announcement. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information.”
The New York-based company is also taking the following steps to address the outbreak:
- Testing all batches of formula with a third-party laboratory.
- Providing the FDA and California Department of Public Health access to company facilities and allowing testing of any unopened cans of formula.
- Sharing results from all testing as soon as they become available.
How did infant botulism outbreak begin?
The first cases of infant botulism tied to this outbreak were diagnosed in August. All of the babies who have fallen ill are between the ages of 2 weeks and 5 months old and were hospitalized after consuming the ByHeart formula, according to the U.S. Centers for Disease Control and Prevention (CDC).
Health officials in California tested an open can of the formula. It was found to contain a type of bacteria that causes a toxin linked to the outbreak.
The company noted that the illness-causing bacteria has not been found in any unopened products and that it is widespread in the environment and could come from sources other than the formula.
Currently, health officials are investigating 84 cases of infant botulism that have been detected since August 9. Of those, 15 had consumed the ByHeart formula, according to the FDA.
“This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States,” the agency said.
Along with Arizona, cases have been reported in California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
The outbreak has not been tied to any other infant formula brands or exposure sources, according to officials.
Causes and symptoms of infant botulism
Infant botulism is caused by a type of bacteria, spread by spores, that can produce a toxin in the large intestine. It typically affects fewer than 200 babies in the U.S. each year.
The most common way for infants to be exposed to the bacteria is through food. Infants are especially vulnerable to the disease as their bodies are not developed enough to prevent the spores from germinating and creating the toxin.
Children are typically exposed to the spores in dirt, dust, water or by eating contaminated honey.
Symptoms can take weeks to develop and include loss of head control, lack of an appetite, drooping eyelids and a flat facial expression, along with problems swallowing or breathing.
The illness can cause infants to be placed on ventilators and, in serious cases, can cause paralysis.
The only known treatment for infant botulism is BabyBIG, an IV medication made from the blood plasma of adults who have been immunized against botulism.
Vials of the medication cost $69,300 apiece, according to the California Department of Public Health.
All of the children who have fallen ill in the ByHeart outbreak have been treated with BabyBIG, the CDC said.
The Associated Press contributed to this report.
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