FDA advises to avoid probiotics for preterm infants due to fatal health risks

FDA advises to avoid probiotics for preterm infants due to fatal health risks | Credits: Google
FDA advises to avoid probiotics for preterm infants due to fatal health risks | Credits: Google

Washington, United States: The parents and guardians of preterm infants are advised by the US Food and Drug Administration (FDA) to avoid using probiotic products. The FDA underscored that the products could cause fatal health risks among the children of that specific age group.

The research was shared in the public domain after the death of a preterm baby caught headlines. The investigation revealed that the baby was given a probiotic in the hospital, which could be the reason behind the death.

According to the news release by the agency, “Probiotic products contain live organisms such as bacteria or yeast and are commonly marketed as foods, including as dietary supplements.”

Visual Representative of Probiotics | Credits: Google Images

The FDA has warned that giving probiotics to premature babies might make them more likely to get very serious and even life-threatening diseases or infections from the bacteria and yeast in these products.

The FDA has adopted two ways – sending a letter to healthcare providers to let them know about the risks and telling two companies to stop selling these products because it’s not allowed.

According to the reports by CBS News, in the news release, Dr Peter Marks, the director of the FDA’s Centre for Biologics Evaluation and Research, “Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings.”

Through the news release, Marks further mentioned, “With today’s message, we want to warn parents, caregivers and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agency’s rigorous premarket process to evaluate their safety, effectiveness and quality for these medical uses.”

FDA’s comment on these products

While emphasizing the products, the FDA noted that these products are associated with “more than two dozen other reported adverse events in the United States since 2018,” reported CBS News.

US Department for Food and Drug Administration | Credits: Shutterstock image

Details regarding the recent death of a preterm baby

The most recent fatality is associated with the usage of Evivo with MCT Oil, a probiotic product produced by California-based Infinant Health (formerly known as Evolve BioSystems Inc.).

In response to this incident, the product has been recalled. Additionally, Infinant Health, Inc. has received one of the FDA’s warning letters, while the other has been directed to Abbott Laboratories for their product, Similac Probiotic Tri-Blend.

The recent release by the FDA underlined, “Abbott has agreed to discontinue sales of its Similac Probiotic Tri-Blend product and is working with the FDA to take additional corrective actions.”

The FDA said before that probiotics haven’t been given the green light to be used as medicine or biological products for babies. This means that probiotics don’t have to meet the strict manufacturing and testing rules that the FDA uses for other medicines. Instead, they can be sold as dietary supplements in the US, which doesn’t have as strict requirements as medicines do.

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