As a consequence of the complications that may arise as a consequence of being born at such an early age, nearly one-quarter of all babies who are born prematurely in the United States suffer from death. A non-specific intestinal condition known as necrotizing enterocolitis (NEC) is one of the complications that can arise from this condition. There is a possibility that the patient could die as a result of NEC. It has been utilized for a considerable time to prevent neonatal endocarditis (NEC) in preemies.
To accomplish this goal, probiotics, which are comprised of beneficial bacteria that reduce the number of harmful bacteria, have been used. In addition to boosting the immune system of preemies, research has shown that probiotics may also help protect them from sepsis and other potentially life-threatening illnesses. Medical professionals have recently discovered that administering particular probiotics to premature infants may have more negative effects than positive ones. They assert that a sizeable portion of the products sold in hospitals for this purpose have not been subjected to sufficient testing or reviews.
Due to this particular reason, the Food and Drug Administration of the United States is currently disseminating new information to healthcare practitioners concerning the potential risks that probiotics may pose to premature newborns presently being treated in a hospital setting. In addition, the Food and Drug Administration (FDA) sent two warning letters to companies whose products have been linked to adverse events and one death in 2023.
The first of these communications was delivered to Abbott Laboratories, and it contained information about the product known as Similac Probiotic Tri-Blend. The Food and Drug Administration (FDA) has concluded that the product in question is an unlicensed biological and unapproved new medicine. This conclusion was reached based on assertions made on the FDA’s website and in marketing materials. The business has concluded that it will no longer be responsible for the sale of the products.
Neonatal endocarditis (NEC) is one of the most common causes of death in infants.
The second letter, which was addressed to Infinite Health and concerned their probiotic Evivo with MCT Oil, was delivered to them. One of the subspecies of the live bacterium Bifidobacterium longum, known as infantis, was included in this product, marketed for use in healthcare facilities. It was determined that this particular subspecies was responsible for the death of an infant in the year 2023, which was caused by neonatal infectious disease (NEC).
According to the genetic sequencing, the germ determined to be present in the product was identical to the germ found in the infant who had passed away. The company Infinite Health has decided to recall this product voluntarily, and as a result, its sales have been halted in the United States.
Neonatal endocarditis (NEC) is one of the most common causes of death in infants, and it is believed that the presence of harmful bacteria in the digestive tract of a baby is the cause of this condition. Probiotics could be beneficial because they can populate the stomach with beneficial bacteria, which makes it more difficult for harmful bacteria to grow. The majority of probiotics, on the other hand, are not effective in reducing the incidence of NEC, which is a finding that has been reported as disappointing by several clinical investigations.
This may be because various strains of bacteria have quite different effects, as stated by the opinions of certain scientists. To give an example, a number of studies have suggested that the beneficial bacteria present in the well-known probiotic Culturelle may assist infants in developing the strength necessary to combat NEC. On the other hand, other research indicates that a probiotic similar to Bifidobacterium breve does not appear to provide any measure of protection against the disease, at least in this particular group of infants who are extremely ill. This is the case in this specific group of infants.
In addition, it was discovered that it led to an increase in the number of preemies who were diagnosed with neonatal encephalopathy (NEC). Consequently, parents must consult with their pediatricians to acquire guidance regarding the most efficient strategies that can be utilized to foster the growth and development of their infants. They can provide individualized guidance that is tailored to the specific medical requirements of each infant, and they are also able to direct them in making decisions that make the infant’s safety and well-being their top priority.
It is really noticeable now that hospitals have more experience dealing with contaminated formulas and other concerns regarding probiotics for premature newborns.
