HomeBusinessThe Risks of Probiotic...

The Risks of Probiotic Use in Preterm Infants: FDA Warning and Recommendations

Free Subscribtion

In recent years, probiotic products have gained popularity as a dietary supplement for promoting gut health. However, a recent series of events involving preterm infants has led the U.S. Food and Drug Administration (FDA) to issue a warning about the potential risks associated with using probiotics in this vulnerable population. This article aims to explore the FDA’s warning, the reported cases of injuries and deaths, and the implications for healthcare providers and caregivers.

FDA warns about giving probiotics to babies after infant death

Understanding Probiotics and their Use

Probiotics are live microorganisms, such as bacteria or yeast, that are believed to provide health benefits when consumed. They are commonly marketed as foods or dietary supplements. While probiotics have gained recognition for their potential positive effects on gut health, it’s essential to note that no probiotic products have been approved by the FDA for use as drugs or treatments in infants.

The FDA’s Warning and Investigations

The FDA’s warning comes in response to injuries and at least one death in premature infants who were given probiotic products in the hospital. The agency has received reports of more than two dozen injuries associated with these products since 2018. The recent death of a preterm baby who received a probiotic called Evivo with MCT Oil prompted the FDA to investigate further.

Understanding the Risks

According to the FDA, preterm infants who are given probiotics are at risk of developing invasive and potentially fatal infections or diseases caused by the bacteria or yeast present in these products. The agency has identified the bacterium Bifidobacterium longum as a potential culprit in the reported cases. Genetic sequencing confirmed that the bacterium that caused sepsis in the deceased infant was a genetic match to the bacteria contained in the probiotic product.

Lack of FDA Approval and Regulations

One of the key concerns highlighted by the FDA is the lack of FDA-approved probiotic products for use in infants. Unlike drugs or biological products, probiotics fall under the category of dietary supplements, which are not subject to the same rigorous manufacturing and testing standards. This regulatory gap raises concerns about the safety, effectiveness, and quality of probiotics, particularly in vulnerable populations like preterm infants.

Warning Letters and Recalls

As part of their response, the FDA has issued warning letters to companies illegally marketing probiotic products for use in preterm infants. Abbott Laboratories, a well-known infant formula manufacturer, received one of these letters due to its Similac Probiotic Tri-Blend product. Abbott has agreed to discontinue sales of the product and work with the FDA on corrective actions. Another company, Infinant Health, which produced the recalled probiotic Evivo with MCT Oil, has also voluntarily recalled and discontinued the product.

- Advertisement -

Recommendations for Healthcare Providers and Caregivers

The FDA’s warning serves as an important reminder for healthcare providers and caregivers to exercise caution when considering the use of probiotic products in preterm infants. It is crucial to weigh the potential benefits against the potential risks, particularly when these products have not undergone the FDA’s rigorous premarket evaluation for safety, effectiveness, and quality in medical uses.

American Academy of Pediatrics Guidelines

The American Academy of Pediatrics (AAP) has also weighed in on the use of probiotics in preterm infants. Their most recent guidelines do not recommend the routine, universal administration of probiotics to preterm infants, especially those with a birth weight of less than 1000 grams. The lack of FDA-regulated pharmaceutical-grade probiotic products, conflicting data on safety and efficacy, and the potential for harm in a vulnerable population all contribute to the AAP’s cautious stance.

The Potential Benefits of Probiotics

While the FDA’s warning raises concerns about the use of probiotics in preterm infants, it’s important to note that research has suggested potential benefits in certain cases. A review of 106 trials, including nearly 26,000 infants, published in JAMA Pediatrics, found that probiotics with multiple strains of bacteria helped reduce overall infant death, feeding intolerance, and necrotizing enterocolitis, a life-threatening inflammation of the intestines. However, it’s important to distinguish between the products studied in these trials and the specific probiotics implicated in the FDA’s warning.

Conclusion

The FDA’s warning about the use of probiotics in preterm infants highlights the potential risks associated with these products. Healthcare providers and caregivers should exercise caution and consider the lack of FDA approval, potential for harmful infections, and the cautious stance of organizations like the AAP. As research continues to explore the benefits and risks of probiotics, it is crucial to prioritize the safety and well-being of preterm infants in medical decision-making.

― ADVERTISEMENT ―

― YouTube Channel for Dog Owners ―

spot_img

Most Popular

Magazine for Dog Owners

Popular News

Yang Tengbo and Prince Andrew: An Unlikely Bond

Yang Tengbo, also known as Christopher Yang, emerged from a relatively...

TIME100 2025: World’s Most Influential People Revealed

As the world continues to evolve, so do the individuals who...

100 Years of UK-Ukraine Partnership

In a bold demonstration of solidarity and strategic foresight, UK Prime...

― ADVERTISEMENT ―

Read Now

5 Fascinating Throwback Pics of Earth by NASA: Timeless Marvels

As we gaze up at the night sky, it's easy to feel a sense of wonder and awe. Our home planet, Earth, is a beautiful and diverse place, and NASA has captured its splendor in breathtaking photographs throughout the years. These images serve as a reminder of...

Most Taiwanese Question the Trustworthiness of the US, but Believe in its Security Commitment

As tensions continue to escalate in the Taiwan Strait, a recent survey has revealed that a majority of Taiwanese do not consider the United States a "trustworthy" country. However, despite this skepticism, most respondents still express belief in Washington's security commitment to the island. The survey, conducted...

Little Changes, Big Impact: Unlocking the Secrets to a Healthy Heart

As we age, it becomes increasingly important to prioritize our heart health. While the idea of making drastic lifestyle changes may seem daunting, the truth is that small, manageable tweaks to our daily routine can have a profound impact on our cardiovascular well-being. In this article, we'll...

Marijuana and Heavy Metal Exposure: What You Need to Know

Marijuana use has been a topic of much debate and discussion in recent years, with many states legalizing its recreational and medical use. However, a new study has shed light on a potential health concern associated with marijuana use - heavy metal exposure. The study found that...

Vladimir Putin, the 71-year-old: A Controversial Love Story

Vladimir Putin, the 71-year-old President of Russia, has once again found himself in the spotlight for his love life. Recent reports suggest that Putin has embarked on a new romance with a 39-year-old London-educated woman, who is known for her role in censoring internet criticism of the...

The Truth Behind ‘Vampire Facials’: A Shocking HIV Outbreak

In recent years, a trendy cosmetic procedure known as the "vampire facial" has gained popularity among individuals seeking a more youthful appearance. However, a shocking HIV outbreak in New Mexico has shed light on the potential dangers associated with this treatment. At least three women have been...

The Citrus Superstar That Can Supercharge Your Tea’s Antioxidant Powers

Whether you're a tea connoisseur or just enjoy the occasional soothing sip, you're likely well aware of the myriad health benefits that this ancient beverage can provide. From its anti-inflammatory properties to its positive impacts on digestion, gut health, and cardiovascular wellbeing, tea is a true powerhouse...

China’s Communist Party Convenes Pivotal Meeting to Steer Economy Amidst Challenges

As the world's second-largest economy, China finds itself at a critical juncture, grappling with a range of economic headwinds that threaten to undermine its continued growth and prosperity. In the face of these challenges, the Chinese Communist Party has convened its highly anticipated Third Plenum, a four-day...

AI Chatbot Revolutionizes Chemistry: Predicting Chemical Properties and Reactions

In recent years, advancements in artificial intelligence (AI) have paved the way for groundbreaking applications in various fields. One such application is the development of chatbots that possess surprising talent in predicting chemical properties and reactions. These AI-powered chatbots, based on models like ChatGPT, have the potential...

Harvard’s Ultra-Thin Metasurface Quantum Chip Sparks Global Next-Gen Military Tech Race

The Ultra-Thin Metasurface Chip, developed by Harvard physicists, marks a major breakthrough in quantum optics. By collapsing complex optical systems onto a chip just nanometers thick, it paves the way for compact, next-gen quantum processors with military and communication applications, triggering a global race in quantum technology...

Middle East Crisis: Israel Calls for New Sanctions on Iran

The tension in the Middle East has reached a boiling point as Israel calls for new sanctions on Iran. This article provides a comprehensive overview of the recent events and the aftermath of Iran's attack on Israel. We delve into the responses from world leaders, the pressure...

Measles Outbreaks: What Middle-Aged Parents Need to Know

As a middle-aged parent, it is crucial to stay informed and prepared for potential health threats that can affect your children. In recent years, measles outbreaks have become a growing concern, with the number of cases reaching record highs. In this comprehensive guide, we will provide you...

Global News

Install
×