Pulling probiotics from NICUs can put preemies at risk of necrotizing enterocolitis

Maybe probiotics would have saved my son’s life. I’ll never know because when I asked Micah’s care team to consider probiotics to counter the deluge of antibiotics, I was dismissed as senseless.

My son Micah was born at 27 weeks gestation, weighing just over 2 pounds, with a head full of thick, wavy hair. By 6 weeks old, Micah weighed 5 pounds, was beginning to nurse, and was progressing toward discharge. Our lives changed forever one quiet Sunday afternoon when Micah’s health rapidly deteriorated, and he was diagnosed with necrotizing enterocolitis (NEC), a disease I had never heard of and knew nothing about. NEC is arguably the cruelest disease in the NICU and torments families years after their original diagnosis. Since Micah died, I have dedicated my life to building a world without NEC because his story is not unique. It could become even more common now that probiotics have been pulled from NICUs after recent FDA warnings.

NEC is a menacing intestinal disease with an aggressive, abrupt onset that blindsides neonatal clinicians and families. NEC often strikes premature infants like Micah, who have made it through their most precarious first few weeks of life and clinically appear to be improving. Once in motion, there is no cure for NEC. Upon diagnosis, many infants have only hours or days before their gut is necrotic, and the disease advances until the infant dies from sepsis or multisystem organ failure.

Thankfully, Micah survived his initial diagnosis, but he then had to endure multiple bowel resections and spent months in the NICU and PICU. The infants who survive NEC often struggle with lifelong neurological, digestive, physical, and social-emotional complications. When we finally brought Micah home, NEC had left him with short bowel syndrome, end-stage renal disease, and liver disease.

Despite all his complications, Micah was the happiest baby, beaming with the brightest smile. Micah had made it, and we were ready to give him everything he needed to thrive.

But just before his first Christmas and a month before his first birthday, he was readmitted to the PICU. Days later, I cradled Micah on my chest as he took his last breath.

The only effective way to combat NEC is through prevention. In the NICU, a premature infant’s mother’s milk provides the most protection against NEC, and when supplemented with probiotics, the risk of NEC is further reduced. Still, the risks of NEC are not eliminated, and some babies develop and die from NEC, even with their mother’s milk and probiotics.

Micah received protection against NEC from my milk but did not receive probiotics. Our family is shattered without Micah in our arms, and like too many other bereaved NICU families, I can’t help but wonder whether probiotics could have protected Micah from the devastation of NEC.

Families and clinicians desperately need strategies to protect premature infants from NEC, which is why the FDA’s recent move to push probiotics out of NICUs is stunning. After a tragic death of a preterm infant, the FDA released warnings to clinicians, families, and companies about the “possible risks associated with the administration of probiotic products to preterm infants in hospital settings.”

Safety in the NICU is essential, and I am sincerely grateful for the FDA’s focus on flawless interventions. Every child in the NICU deserves perfection. I begged for perfection during Micah’s hospitalizations. Unfortunately, medicine is imperfect, full of risks and benefits, with dedicated physicians working tirelessly to optimize protection. I join the FDA’s call for rigorous evaluation, but sometimes, fixation on perfection renders patients less protected.

Studies show probiotics can reduce NEC and death, as highlighted in the NEC Society’s Probiotics Toolkit. Indeed, many treatments routinely used in the NICU do not have an approved FDA indication for use in preterm infants. Infants in the NICU routinely receive treatments that are far riskier, with significantly less supporting evidence, compared with probiotics. Some routine care practices in the NICU can even inadvertently increase an infant’s risk of NEC. Some of these treatments remain approved by the FDA. I am grateful to the FDA for aiming to safeguard preemies, but we also need the FDA to join the NEC Society’s efforts to accelerate research and evidence-based care practices for infants at the highest risk of NEC and help us develop solutions in partnership with the neonatal community and families. We can simultaneously work toward improved safety and prevention.

The FDA’s warnings highlight the relatively uncommon risks of probiotic sepsis in preterm neonates without acknowledging the overwhelmingly more common risk of necrotizing enterocolitis. Every year in the U.S., thousands of infants are diagnosed with NEC, and one baby dies from NEC every day. NEC is the most common cause of death for premature infants in the NICU after their first two weeks of life, and NEC causes one out of every 10 deaths in the NICU.

We know these numbers are not just statistics, these are children like Micah. Clinicians need the space to decide how treatments or tools, such as dietary supplements, drugs, devices, and other therapies, are used in their practice of medicine with their patients, considering the best available evidence and in partnership with families.

The FDA alerts are impacting clinical care, which may result in less protection against NEC, potentially resulting in more premature infants developing and dying from NEC. The FDA warnings cite the American Academy of Pediatrics’ Statement on Probiotics, and yet the AAP statement provides guidance for NICUs using probiotics.

The FDA warnings have set an unbalanced and harmful precedent of interference with access and physicians’ ability to evaluate a promising tool against a deadly neonatal disease. Families and physicians need the latitude to determine the most promising strategies to protect premature infants from NEC. NICU babies like Micah need perfection, but until we get there, our babies urgently need more protection against NEC.

Jennifer Canvasser, MSW, is the founder and executive director of the NEC Society.