Current:Home > NewsFDA investigating baby's death linked to probiotic given by hospital-Angel Dreamer Wealth Society D1 Reviews & Insights
FDA investigating baby's death linked to probiotic given by hospital
View Date:2024-12-23 23:07:56
The Food and Drug Administration is now warning hospitals not to give probiotics to preterm infants, after a baby was killed by bacteria linked to a probiotic.
An investigation has also now been launched into the death, the FDA announced in a warning published Friday, which followed use of Evivo with MCT Oil, a probiotic manufactured by California-based Infinant Health that is now being recalled.
"Genomic sequencing data demonstrate the bacterium that caused sepsis in this infant was a genetic match to the bacteria contained in this probiotic," the agency said.
It is not clear which hospital administered the probiotic now being investigated by the FDA. An agency spokesperson did not immediately respond to a request for comment.
In a statement, a spokesperson for Infinant Health said the company is "cooperating with FDA's ongoing investigation." The company has voluntarily agreed with FDA to stop shipping its Evivo with MCT Oil product, the spokesperson said.
"That product was used by health care professionals in hospital settings, including neonatal care for preterm infants," the company said in its statement.
In a separate warning letter Friday, the FDA also alleged Infinant Health had overstepped its boundaries as a dietary supplement manufacturer. Medical claims about the product were on par with an "unapproved new drug and unlicensed biological product" that would be illegal to sell in the U.S.
The company is planning to continue distributing its "Evivo powder product" for consumers to buy, Infinant Health's spokesperson said. They also intend "to work with the FDA toward approval of the use of our MCT oil product in hospital settings."
In a May news release, Infinant Health had claimed its Evivo probiotics are "widely used by parents" as well as in hospitals and neonatal intensive care units "throughout the U.S."
Probiotics are bacteria eaten for health benefits, such as those in yogurt or supplements. Studies have shown some benefits for infants taking probiotics in guarding against some diseases.
Infinant Health makes a number of claims about its Evivo product for consumers, including that babies fed the probiotic have better sleep, less diaper rash and "a healthy gut microbiome."
"For parents asking, 'Should I give my baby probiotics?' note that 80% of our immune system is in our gut. It's imperative to care for your baby's gut microbiome today to give them a strong foundation for good health," the company says.
On its website, the company says in an FAQ for doctors that the product can be started "right after birth" alongside breast milk.
The FDA warns that no probiotics have been approved for use as a drug or biological product in babies, meaning probiotics are not subject to the "agency's rigorous manufacturing and testing standards" for other medications regulated by the FDA.
Instead, probiotics are allowed to be sold in the U.S. as dietary supplements, bypassing the FDA's higher bar for drug and biologics approvals.
"Evivo is a food for special dietary use, meeting all FDA regulations for food products, and has been used by parents, hospitals and providers for five years with over 4.7 million feedings to date in over 60,000 babies," the company said in its May news release.
The FDA also pointed to recommendations from the American Academy of Pediatrics counseling against wide use of probiotics for preterm infants.
That 2021 report cited data suggesting 1 in 10 "extremely low gestational age" babies were now being given probiotics by hospitals.
"Given the lack of FDA-regulated pharmaceutical-grade products in the United States, conflicting data on safety and efficacy, and potential for harm in a highly vulnerable population, current evidence does not support the routine, universal administration of probiotics to preterm infants," the report's authors wrote.
Alexander TinCBS News reporter covering public health and the pandemic.
veryGood! (6)
Related
- Glen Powell responds to rumor that he could replace Tom Cruise in 'Mission: Impossible'
- Elon Musk says NPR's 'state-affiliated media' label might not have been accurate
- This Leakproof Water Bottle With 56,000+ Perfect Amazon Ratings Will Become Your Next Travel Essential
- ‘Stripped of Everything,’ Survivors of Colorado’s Most Destructive Fire Face Slow Recoveries and a Growing Climate Threat
- Who will be in the top 12? Our College Football Playoff ranking projection
- Businesses face more and more pressure from investors to act on climate change
- Sabrina Carpenter Has the Best Response to Balloon Mishap During Her Concert
- Women are earning more money. But they're still picking up a heavier load at home
- Pennsylvania House Republicans pick new floor leader after failing to regain majority
- Kelsea Ballerini Speaks Out After Onstage Incident to Address Critics Calling Her Soft
Ranking
- Kate Hudson and Goldie Hawn’s SKIMS Holiday Pajamas Are Selling Out Fast—Here’s What’s Still Available
- Search continues for 9-month-old baby swept away in Pennsylvania flash flooding
- Dear Life Kit: My boyfriend's parents pay for everything. It makes me uncomfortable
- The Fed's radical new bank band-aid
- Armie Hammer Says His Mom Gifted Him a Vasectomy for His 38th Birthday
- Inside Clean Energy: In Illinois, an Energy Bill Passes That Illustrates the Battle Lines of the Broader Energy Debate
- The one and only Tony Bennett
- Will There Be a Barbie Movie Sequel? Margot Robbie Says...
Recommendation
-
Get Your Home Holiday-Ready & Decluttered With These Storage Solutions Starting at $14
-
This Leakproof Water Bottle With 56,000+ Perfect Amazon Ratings Will Become Your Next Travel Essential
-
Full transcript of Face the Nation, July 23, 2023
-
Gloomy global growth, Tupperware troubles, RIP HBO Max
-
Opinion: NFL began season with no Black offensive coordinators, first time since the 1980s
-
Climate Change is Spreading a Debilitating Fungal Disease Throughout the West
-
Researchers Say Science Skewed by Racism is Increasing the Threat of Global Warming to People of Color
-
Justice Department threatens to sue Texas over floating border barriers in Rio Grande