In recent months, the Food and Drug Administration (FDA) has issued a stern warning regarding the use of probiotics in preterm infants, shedding light on the potential dangers associated with these products. At the heart of this warning is a tragic incident involving the death of an infant, which has prompted the FDA to take action.
FDA Raises Alarms Over Probiotics for Preterm Infants
The FDA’s warning comes in response to a deeply concerning incident involving a hospitalized preterm infant who was administered probiotics. Tragically, this infant developed sepsis and ultimately lost their life. As a result, the FDA has sounded the alarm, not only to healthcare providers but also to the companies involved in selling probiotics for preterm babies. The agency has issued stern warning letters to these companies for their illegal promotion of these products to treat or prevent diseases in preterm babies.
“The FDA is concerned as these products can be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preterm infants in hospital settings, such as to reduce the risk of necrotizing enterocolitis,” stated the agency. The use of probiotics in a premature infant, which has been linked to 24 other reported adverse events since 2018, poses a significant risk. These vulnerable infants are susceptible to invasive and potentially fatal diseases or infections caused by the bacteria or yeast contained in probiotics.
Understanding the Risks of Probiotics in Infants
Probiotic products, commonly marketed as foods, powdered infant formula, and dietary supplements, contain live organisms, including bacteria and yeast. While they are generally considered safe for adults, the same cannot be said for premature infants. The FDA’s warning underscores that preterm infants given probiotics to combat enterocolitis – a condition marked by inflammation of the intestines – may be putting their lives in danger. Since 2018, the agency has been tracking adverse events related to probiotics in infants, and the results are alarming.
“The agency is also concerned about and is investigating reports that these products may have contributed to additional adverse events, including death, and is working to obtain the proper evidence and medical records, where possible,” the FDA stated. Furthermore, it’s crucial to understand that the FDA has not approved the use of probiotics in infants of any age, as these products have not undergone thorough evaluation regarding their safety and effectiveness.
The Ongoing Investigation
The tragic incident that prompted the FDA’s recent warning involved a preterm infant who was given a probiotic product called Evivo with MCT Oil manufactured by Infinant Health. Regrettably, it caused sepsis, a life-threatening condition when the body’s immune system has an extreme response to an infection, which caused the infant death. While the letter did not disclose the location of this heartbreaking event, it underlines the grave consequences of using probiotics in infants.
In response to these concerns, the FDA has not only issued warnings but has also initiated investigations into companies that are selling probiotics for premature infants.
Abbott Laboratories, a prominent player in the industry, received a warning letter from the FDA regarding their product, Similac Probiotic Tri-Blend, which was being marketed for use in infants in hospital settings. This product contains three bacterial strains: B. infantis, S. thermophilus, and B. lactis.
Your Legal Rights and Protection
In light of the FDA’s recent warnings and ongoing investigations, our law firm is here to help you understand your legal rights and the avenues available to protect them. If you or a loved one has been affected by the use of probiotics in infants and have suffered adverse events, including potentially fatal infections, it’s crucial to seek legal counsel.
Wrongful Death Claims: The loss of a child due to the use of probiotics in infants is a devastating and tragic event. In such cases, families may consider pursuing wrongful death claims. Wrongful death claims seek to hold those responsible for the loss of a loved one accountable for their actions or negligence.
Our legal team has the experience and compassion needed to guide you through this difficult process, ensuring that justice is served and your family’s rights are protected.
Medical Malpractice: In cases where healthcare providers are involved in the administration of probiotics to infants, it’s essential to evaluate whether medical malpractice played a role. Medical malpractice occurs when healthcare professionals fail to meet the standard of care expected in their field, resulting in harm or injury to the patient. If healthcare providers do not exercise due diligence in following the FDA’s warnings and guidelines, they may be liable for medical malpractice.
Our law firm has a track record of handling complex medical malpractice cases and can help you seek compensation for any harm caused.
Product Liability: The companies that manufacture and distribute probiotics for infants bear a significant responsibility for the safety of their products. If their probiotics have been linked to complications or deaths, they may be held liable under product liability laws. Product liability claims can be pursued when a product is deemed defective or unreasonably dangerous, and it causes harm to consumers.
Our legal team has the expertise to assess whether the probiotics involved in your case meet the legal criteria for product liability claims and can work to secure compensation for your suffering.
Take Action to Protect Your Rights With BLG
If you or your loved one has been impacted by the use of probiotics in preterm infants, the time to take action is now. The FDA has made it clear that these products can pose serious risks to preterm infants, and their use in hospital settings is a cause for concern. Don’t hesitate to seek the legal guidance you need to protect your rights and secure the justice you deserve.
At BLG, we are committed to advocating for those affected by the dangers associated with probiotics in preterm infants. Contact us today to discuss your situation and explore the legal options available to you. Your child’s health and your rights matter, and our team of top-rated lawyers is here to help you seek justice.
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