The U.S. Food and Drug Administration (FDA) has issued a cautionary message to hospitals regarding the use of probiotics for preterm infants, following the death of a baby who was given the supplement. The FDA warned that probiotics can pose a risk of invasive and potentially fatal diseases caused by the bacteria or fungi contained in these products. While Canadian hospitals also administer probiotics to preterm infants, Health Canada has not issued a similar warning.
Global News sought comment from Health Canada about the use of probiotics on preterm infants but did not receive a response. In a position statement from 2022, the Canadian Paediatric Society acknowledged that probiotics are generally considered safe for infants but highlighted cases of sepsis in premature babies associated with their use. The long-term effects of probiotics on the developing immune system are still unknown.
Probiotics, such as bacteria or yeast, are live microorganisms often taken in the form of capsules or liquid drops for their health benefits. In Canada, they are classified as natural health products and regulated similarly to vitamins, minerals, and herbal remedies.
Administering probiotics to premature infants is done to prevent necrotizing enterocolitis (NEC), a condition that causes inflammation in the gastrointestinal tract and can lead to severe complications or death. Dr. Belal Alshaikh, a neonatologist at Alberta Health Services, emphasized the potential lifesaving benefits of probiotics for preterm infants, despite the associated risks. He stated that the number of lives saved outweighs the minimal cases of infection caused by the specific strain of bacteria in probiotic products.
In Canada, probiotics approved for preterm babies have received approval from Health Canada as supplements. Unlike the U.S., probiotics are not well-regulated in the United States, which prompted the FDA’s warning. Alshaikh stated that he only uses probiotics approved by Health Canada and under its regulation.
The FDA’s warning was prompted by a case involving a preterm infant with a birth weight of under 2.2 pounds who developed sepsis after being given a probiotic called Evivo with MCT Oil. Genomic sequencing data showed that the bacterium causing the sepsis was a genetic match to the bacteria in this specific probiotic. Evivo with MCT Oil, manufactured by Infinant Health in California, has voluntarily recalled its product in response to the FDA warning. The product is not available in Canada.
Sepsis is a life-threatening condition that occurs when the body’s response to an infection damages its own tissues and organs. It can lead to organ failure, shock, and death if not treated promptly. Alshaikh explained that sepsis in preterm infants can occur if microorganisms from probiotics enter the bloodstream and cause infection. However, probiotics can also decrease sepsis by preventing harmful bacteria from infecting these infants.
While there have been rare reports of illness or death in preterm babies linked to microorganisms in probiotics, the Canadian Pediatric Society stated that present evidence suggests probiotics can decrease mortality and lower the incidence of NEC in preterm and low birth weight babies. Probiotics may also be beneficial in reducing symptoms of colic, although there are associated risks, particularly in immunocompromised or premature infants.
Alshaikh’s own study published in Cell Host & Microbe in 2022 found that probiotic supplements containing the appropriate microbes can help establish a healthy microbiome for infants born without a fully formed gut microbiome. The study focused on infants born at less than 29 weeks gestation and weighing less than 2.2 pounds at birth.
Denial of responsibility! Vigour Times is an automatic aggregator of Global media. In each content, the hyperlink to the primary source is specified. All trademarks belong to their rightful owners, and all materials to their authors. For any complaint, please reach us at – [email protected]. We will take necessary action within 24 hours.
