50-Plus Babies Sickened in Botulism Outbreak

Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022. The US Food and Drug Administration said investigators "cannot rule out the possibility that contamination might have affected all ByHeart formula products" ever made, per the AP.

• The outbreak now includes at least 51 infants in 19 states. The new case definition includes "any infant with botulism who was exposed to ByHeart formula at any time since the product's release," according to the CDC. The most recent illness was reported on Dec. 1. No deaths have been reported in the outbreak, announced Nov. 8.

• Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That's when officials at California's Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who'd consumed ByHeart formula. Another 12 cases were identified with the expanded definition.
• ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all of its products sold in the US on Nov. 11. The company, which accounts for about 1% of the US infant formula market, had been selling about 200,000 cans of the product each month. In a statement Wednesday, ByHeart officials said the company is cooperating with federal officials "to understand the full scope of related cases."

• Infant botulism is a rare disease that affects fewer than 200 babies in the US each year. It's caused when infants ingest botulism bacteria that produce spores that germinate in the intestines, creating a toxin that affects the nervous system. Babies are vulnerable until about age 1 because their gut microbiomes aren't mature enough to fight the toxin. Baby formula has previously been linked to sporadic cases of illness, but no known outbreaks of infant botulism tied to powdered formula have previously been confirmed, per research studies.
• Symptoms can take up to 30 days to develop and can include constipation, poor feeding, loss of head control, drooping eyelids, and a flat facial expression. Babies may feel "floppy" and can have problems swallowing or breathing.
• The sole treatment for infant botulism is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California's infant botulism program developed the product and is the sole source worldwide. More here.