The FDA Warns of Fatal Health Risks Associated with Probiotics for Preterm Infants
The U.S. Food and Drug Administration (FDA) issued a warning on Thursday, cautioning that probiotics for preterm infants could have potentially deadly consequences. The agency revealed that one infant death earlier this year was linked to probiotic products, and since 2018, over two dozen adverse incidents involving infants have been associated with these products. The FDA is currently investigating additional cases.
In a news release, the health regulator explained that probiotic products, which contain live organisms like bacteria or yeast, are commonly marketed as foods and dietary supplements. However, the FDA has not approved any probiotics for infants of any age. Despite this, some hospitals have been using probiotics to treat certain diseases in preterm infants.
The FDA emphasized that these probiotic products can be dangerous for preterm infants and are being illegally sold as treatments or preventatives for diseases. The live bacteria or yeast contained in the probiotics can put these infants at risk of invasive and potentially fatal diseases or infections.
The FDA also issued a warning letter to a company that sells probiotic products for use in hospital settings for preterm infants. The agency stated that based on the company’s intended uses and marketing materials, the product is an unapproved new drug and an unlicensed biological product, violating federal laws.
One incident mentioned in the notice involved a preterm infant who developed sepsis after being given a probiotic product called Evivo with MCT Oil, manufactured by Infinant Health. Sepsis is a life-threatening condition that occurs when an infection spreads throughout the body, causing organ failure and tissue damage. The specific hospital where the probiotic was administered and further details about the incident were not provided.
Dr. Peter Marks, a top FDA official, emphasized the serious risks that live microorganism-containing products pose to preterm infants in hospital settings. He urged parents, caregivers, and healthcare providers to exercise caution when using these products for disease prevention or treatment, as they have not undergone the FDA’s rigorous evaluation for safety and effectiveness.
A woman shops for yogurt, a food commonly associated with good gut bacteria known as probiotics. (Olga Maltseva/AFP/Getty Images)
The American Academy of Pediatrics has issued guidelines stating that current evidence does not support the routine administration of probiotics to preterm infants, particularly those with a birth weight of less than 2.2 pounds. However, a recent survey published in JAMA Pediatrics found that probiotics with multiple strains of bacteria can reduce infant mortality and inflammation of the intestines caused by necrotizing enterocolitis.
Probiotics, which are beneficial bacteria found in yogurt, kefir, and supplements, are consumed for their health benefits. Infinant Health, the manufacturer of Evivo with MCT Oil, has stated that their product contains only one strain of bacteria. The company has agreed to cooperate with the FDA’s investigation and has halted the distribution of the product.
In a statement, Abbott, a major infant formula manufacturer, clarified that the FDA’s warning does not apply to their retail infant formula products. They assured parents and caregivers that Similac infant formulas remain safe for use.
In September, the FDA issued a public warning to Infinant Health, describing Evivo with MCT Oil as an unapproved new drug and unlicensed biological product.
The FDA highlighted the vulnerability of preterm infants due to their immature gastrointestinal systems, which can lead to infections and sepsis when exposed to living microorganisms. The agency emphasized that the current literature does not provide a consensus on the safety of using live microorganisms in preterm infants.
Why does the FDA recommend consulting with medical professionals before administering probiotics to preterm infants?
Roducts and to consult with medical professionals before administering any probiotics to preterm infants. The FDA recommends that healthcare providers obtain clear and accurate information about the products they use and ensure they are safe and effective.
The warning from the FDA serves as a reminder of the importance of thorough research and regulation when it comes to healthcare products, particularly those meant for vulnerable populations like preterm infants. The potential dangers of using unapproved or unlicensed products cannot be taken lightly, as they can have severe consequences for the health and well-being of these infants.
It is crucial for medical professionals to have access to accurate information and guidelines to ensure the safety and proper treatment of preterm infants. The FDA plays a vital role in monitoring and regulating healthcare products to protect the public and prevent harm. This incident serves as a call for stricter regulations and oversight in the production and marketing of probiotics and other healthcare products.
Parents and caregivers should also be cautious and informed when it comes to choosing and using healthcare products for their infants. Consulting with healthcare providers and conducting thorough research can help ensure that the products used are safe and appropriate for preterm infants.
In conclusion, the recent warning from the FDA regarding the potential fatal health risks associated with probiotics for preterm infants highlights the need for strict regulation and careful consideration when it comes to healthcare products. Medical professionals, parents, and caregivers must exercise caution and seek expert advice to ensure the safety and well-being of preterm infants. The FDA’s investigation and warnings serve as a reminder of the importance of thorough research, regulation, and oversight in the healthcare industry to prevent potential harm to vulnerable populations.
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