May 23, 2024
Health News

Probiotics: The FDA Banned It for Babies After Infant Death


icMost of you must have heard of probiotics. Your doctor must have prescribed it when taking antibiotics or to improve gut health. Indeed, these probiotics are the best way to keep yourself healthy and away from any gut-related health issues. But sometimes misuse of these helpful drugs can be harmful to your loved ones. The government agencies show concern for the sale of probiotics to the various hips in the US to treat issues in infants. Yes, you have heard me right. As per the FDA or Food or Drug Administration, Probiotics are not best for young babies as it leads to infant death in most cases. The FDA will make this statement public on October 26, 2023.

 It gives rise to various conceptions. What happened? Although probiotics are best for the gut, they are not recommended for newborns. So in this blog, we will work on what probiotics are. What is the purpose of this? Which statement FDS has to say about it and more.

 What is Probiotics?

Before moving further let us talk about probiotics. What are they? Is it healthy for the babies? It is a living organism and it is the same as the human flora that lives in one’s GIT. Many people or doctors prescribe it and use it as a supplement, leading to impaired digestion and gut health.

 Probiotics consist of live bacteria and other microorganisms. Many people in the USA use it as a supplement or dietary supplements. Why are we tagging it as an addition? Because it is not a drug. Here is the point: the FDA does not review it for its effectiveness and safety. But when we talk about babies, there needs to be ar study about them. The researchers need to assess the efficacy and safety of probiotics for infants or babies.

 Probiotics and infants

 Now you understand what probiotics are. Now the query is: if it has the living microorganisms that are present in the human body then why does it cause death in infants? It is the main question. So her FDA has conducted various research showing that probiotics can interact with various medical diseases and drugs. Hence, it can cause infection, specifically in young babies.

probiotics and infants

Now let us talk about infant deaths because of probiotics this year. As per the FDA, about a dozen adverse cases have occurred since 2018 because of the link to this item. So the researchers are working to determine whether bacteria are the main cause.

FDA-Approved Probiotics for Infants

So, you now have a better learning of these items what they are, and much more. But are there any FDA-approved probiotics? No the FDA has not approved probiotics for infants to date. This statement is from the agency. But you cannot deny the fact that some items drugstores sell illegally to treat diseases in preterm babies in a hospital setting.

Last month, the agent sent the letter to healthcare providers. The purpose of this letter is to warn them about using probiotices in preterm infants. What is the reason behind it? It is because of the risk of invasive, potentially fatal infections.

What was in the letter? The letter stated that babies who are in hospital settings after birth have been given probiotics items called Evivo with MCT Oil. This leads to sepsis.

To learn more about this sepsis and why medical experts administer these probiotics move to the next section. In the next part we will work on the necrotizing enterocolitis and this diety item. So let us find out more about it in great detail.

Probiotics and Necrotizing Enterocolitis 

 So now you know all about these items. Probiotics consist of living organisms like yeast or bacteria. Do you know the FDA marked it as a food or a diet supplement? Here the concern of the FDA is that these are treating illnesses in preterm babies in hospital setups, like minimising the chances of necrotising enterocolitis. When medical experts administered probiotics to preterm babies it caused fatal and invasive infections. Who drives this infection? It is the bacteria that are present in the probiotics.

After this, a preterm baby develops sepsis, leading to life-threatening situations when the human body is highly responsive to diseases. Hence it led to his death. In the letter by the FDA, you can find all these details. However the FDA letter did not address the death or provide any further data.

So let us shed more light on the probiotics and the treatment of necrotising enterocolitis. We cannot say that the FDA is aware of the use of probiotics in hospital settings to prevent necrotising enterocolitis. This has added to various illnesses one of which is the death of infants in 2023. When the FDA investigated they discovered that many adverse events had occurred in the United States since 2018. There were many reports that these probiotics caused various bad effects like death. Today many researchers and firms are studying to find a clear link between the problems and the illness.

The Real Case

The U.S. Food and Drug Administration or FDA has alerted against giving probiotics to preterm infants after a ten-month-old baby died after having a probiotics .So what actually happens? When medical experts administered the probiotics the preterm baby developed the bloodstream disease with Bacillus subtilis. What is this? it is the bacteria that are normally present in soil. Many firms are using it to make probiotics supplements. The FDA is now investigating this case and has urged parents and caretakers not to give this to babies.


The FDA knows the effects of the issues and is working with various health care experts to learn better the link between the adverse effects and probiotics in preterm babies. Further FDA has also sent a letter to Abbot about the prebiotics for the infant and their impact. Let us move forward and learn more about them in great detail.

FDA and Abbot

FDA and Abbot

The FDA also sent a warning letter to the ABBOT on Thursday about the problems. In that letter FDA talked about its items, Similac Probiotics Tri Blend. Agencies sold this item to the hospital for preterm babies. It consists of three bacteria strains:

  • B. infantis
  • S. thermophilus 
  • B. lactis.

It is not clear whether the items led to any bad events in babies. Still, Abbott settled to stop sales and is toiling with the FDA to take other curative actions as per the agency. So what is the response of the Abbot?


So, Abbott did not directly respond to a demand for comment. The FDA also noted that probiotics have been reported in medical books to induce serious bacterial or fungal infections, mainly in low birth weight or preterm infants.

Of note, this Abbott probiotics item is not a preterm baby formula. It is unrelated to the last issue the agency has registered with powdered baby formula made by Abbott Nutrition. So Abbott has approved to stop sales of its Similac Probiotic Tri-Blend product. Currently Abbot is working with FDA to take extra punitive actions. Now let us move ahead and find out what the director of FDA has to say about this.

Dr. Peter Mark of the FDA’s Center for Biologics Evaluation and Research

Now you know about probiotics and how it is causing death in preterm infants. But let us see what Dr. Peter has to say about it. He states that he specifically likes to clarify that items containing live organisms like fungi or bacteria may cause serious illnesses in newborn babies in hospital setups. Hee satisfies this in his Thursday statement.

He further added that he would like to be aware of the advice of health care experts and cares about the use of probiotics for the treatment or prevention of illness they experience during the premarket process of the agency to check the safety of probiotics usage.

The American Academy of Pediatrics never suggests the usage of this item in preterm babies. Although the firm says about 10 per cent of preterm babies receive a probiotics during their stay in the neonatal intensive care unit.

 Safety Tips For Parents

So the caretaker or the parent who is thinking of giving the probiotics to their babies must consult the doctor first. Never give them any drugs without any medical supervision. Because of the recent cases, the FDA strongly advises that the parents give the probiotics to the babies after the medical prescription by the expert.

 Here are extra safety leads for caregivers and parents.

  • Never give probiotics to tots under six months old.
  • Also never give this to babies who already have any antibiotics or contain other medical issues.
  • Talk to the doctor before giving it to the baby.
  • Pick probiotics that firms make for babies only.
  • Follow the label of probiotics for the dose.
  • Store them in a cool and dry place.


The agency resumes to review and analyse adverse event reports for probiotics. So to inform the surveillance efforts of the agency and to better learn these issues to assist in defending public health the FDA has taken some action. The FDA urges healthcare experts and parents to report adverse events following the usage of probiotices to the maker FDA watch program and more.

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