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Infinant Health has provided the following clarifying information and an official statement following a recent FDA warning against the use of probiotics in preterm infants:
On October 26, 2023, FDA issued a news release summarizing the agency’s concerns about probiotic products sold for use in hospitalized infants. According to the release, “FDA is aware that certain probiotic products used in hospital settings to prevent necrotizing enterocolitis have contributed to invasive disease, including one infant death in 2023, and have been associated with more than two dozen other reported adverse events in the United States since 2018.” Further, FDA “is investigating reports that these products may have contributed to additional adverse events, including death.” The release does not attribute any specific adverse events to any specific product.
Infinant Health initiated a voluntary recall of its probiotic product Evivo with MCT Oil on September 27, 2023. After a recall has been initiated, FDA classifies the recall into one of three classes, based on the relative degree of health hazard presented by the product being recalled:
(1) Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
(2) Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
(3) Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
On October 24, FDA classified the recall of Evivo with MCT Oil as Class II. Confirmation of that classification is available on this FDA web page. FDA has not shared the basis for that classification with Infinant Health. Therefore, any questions in that regard should be directed to FDA.
Evivo with MCT oil was sold for use only by healthcare professionals in a hospital setting. Evivo powder product, available on the commercial market for use in full term infants, is not being recalled and is not the subject of FDA’s investigation.
If you have questions, please contact Sales Director Carrie McGuckin email@example.com.
Evivo® Infant Probiotic
A breakthrough in infant care, so you can help babies thrive. Evivo is a daily infant probiotic containing a single bacterial strain, B. infantis EVC001, shown to work with breast milk to nourish baby, protect the gut, & support immune systems to help with:
- Gas, fussiness, & colic4
- Loose or watery stools4
- Diaper rash or other minor skin irritations5
- Restless sleep4
EVC001: Strain matters
Scientific evidence shows B. infantis naturally belongs in the infant gut. However, 9 out of 10 babies in the US are missing B. infantis due to antibiotic usage and modernized feeding and birthing practices over time.7,8
B. infantis is required for the metabolism of Human Milk Oligosaccharides (HMOs) contained in breast milk. But strain matters—unlike other probiotics, the mechanism of action of B. infantis EVC001 is well established. Without B. infantis EVC001, research shows HMOs are undigested and directly excreted into the stool.
A powerful presence in the gut: In clinical trials, after feeding Evivo, 100% of babies studied were colonized with B. infantis. To date, no other clinical study has demonstrated such a substantial and persistent beneficial change in the gut microbiome.
B. infantis EVC001 is clinically shown to:
- Nourish: Help maximize nutrition from breast milk to positively impact baby’s gut health and overall development.2
- Guide: Help guide healthy immune function2,3
- Protect: Replenish good gut bacteria to help with gas, fussiness, loose or watery stools, and diaper rash.1,4,5
Five world-renowned researchers at University of California, Davis came together around a single goal – improving health through diet and the gut microbiome.
Decades of their research on breast milk found that it promotes the growth of B. infantis EVC001, the single strain in Evivo, to establish a healthy gut microbiome, which protects baby from within
Learn how early attention to the gut microbiome can change lives. Explore educational webinars, peer-reviewed publications, and articles.
Frese, et al. “Persistence of supplemented Bifidobacterium longum subsp. infantis EVC001 in breastfed infants.” MSphere 2.6 (2017): e00501-17.; 2. Henrick, et al. “Bifidobacteria-mediated immune system imprinting early in life.” Cell 184.15 (2021): 3884-3898; 3. Henrick, et al. “Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.” Pediatric research 86.6 (2019): 749-757; 4. Smilowitz, et al. “Safety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial.” BMC pediatrics 17.1 (2017): 1-11; 5. Dimitratos, et al. Symptomatic relief from at-home use of activated Bifidobacterium infantis EVC001 probiotic in infants: results from a consumer survey on the effects on diaper rash, colic symptoms, and sleep. Benef Microbes. 2021:1-8. doi:10.3920/bm2020.0229; 6. Duar, et al. “Integrating the ecosystem services framework to define dysbiosis of the breastfed infant gut: the role of B. infantis and human milk oligosaccharides.” Frontiers in nutrition 7 (2020): 33; 7. Henrick, et al. “Elevated fecal pH indicates a profound change in the breastfed infant gut microbiome due to reduction of Bifidobacterium over the past century.” MSphere 3.2 (2018): e00041-18; 8. Casaburi, et al. “Metagenomic insights of the infant microbiome community structure and function across multiple sites in the United States.” Sci Rep 11, 1472 (2021).; Davis et al. 2016 Mol Cell Proteomics;
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At Synova, we are a nurse leadership institute. We strive to change how nurse leadership works and the scope of the very field. We aim to shape a diverse work environment that endorses opportunities for both personal and professional growth. Synova Associates encourages an inclusive workforce that complements that of women, neonates, and their families.