Babies are born with very little vitamin K in their bodies, so one of the first shots they receive is an injection of the nutrient within hours of entering the world.
It’s a simple step to prevent a potentially life-threatening problem. Vitamin K is needed to support normal blood clotting. Without it, babies can bleed uncontrollably into their intestines and brains, which can lead to brain damage and death, the Centers for Disease Control and Prevention warned. The risk persists for the first six months of life.
The single shot, injected into a baby’s leg, has been a standard of care in the U.S. since the American Academy of Pediatrics recommended it in 1961. Newborns who don’t get the injection are 81 times more likely to develop severe bleeding than those who get the jab, the CDC noted.
But doctors and medical societies have become alarmed by increased vitamin K hesitancy among parents in recent years.
The incidence of vitamin K deficiency bleeding in babies — which had been virtually eliminated with the routine shot — appears to be going up because more parents are refusing the injection for their newborns, the AAP warned in a policy statement this year.
“Unfortunately, parental refusal of neonatal vitamin K has been increasing,” echoed the InfantRisk Center, a non-profit that provides information about the effects of medications on newborns.
Parents should “consider the horrible outcomes of this decision,” said the center, which is based at the Texas Tech University Health Sciences Center School of Medicine in Amarillo.
Uncontrolled bleeding “remains a significant concern in newborn and young infants,” but most families are not aware of the serious consequences, the AAP cautioned.
Trend shocks pediatricians
Vitamin K hesitancy seems to go hand-in-hand with vaccine hesitancy, but it hasn’t gotten as much attention, said Dr. Phoebe Danziger, a pediatrician at Munson Healthcare Otsego Memorial Hospital in Gaylord, Michigan.
She finds the trend “shocking” and has become passionate about raising awareness about the issue.
“It really was surprising to me that families started to become suspicious of this intervention… (the shot) seems like such an obvious win-win for everybody,” Danziger told TODAY.
“Here we have a potentially really scary condition that’s rare, but truly happens, where babies can develop really serious and even fatal bleeding. And then we have this really straightforward, simple intervention that carries exceedingly low risk of any serious side effects and virtually eliminates the risk of the bleeding complications.”
When Danziger previously practiced at University of Michigan Hospitals and Health Centers in Ann Arbor, she said she saw vitamin K hesitancy among parents of newborns every day, but experiences it less frequently in the rural community hospital where she now works.
The trend seems to vary based on the setting where a baby is born: The frequency of vitamin K shot refusal ranged from 0% to 3.2% in U.S. hospitals, up to 14% in home births and up to 31% in birthing centers, a 2020 review of studies found.
The odds of refusal were six times greater for infants delivered by a certified nurse midwife versus a physician, Danziger and her colleagues reported in a study published in 2019.
One of the first “warning bells” to shine a spotlight on the problem was a cluster of babies suffering from vitamin K deficiency bleeding in Tennessee, she noted. Four cases were diagnosed at a hospital in Nashville in 2013: three infants had bleeding in the brain and the fourth had gastrointestinal bleeding. None of the infants received a vitamin K shot at birth, the CDC reported. All survived.
Why families refuse
Some parents object to the injection because they believe it isn’t natural for babies, Danziger said. Others worry the ingredients in the shot might be dangerous or cause dangerous side effects, even though there’s no evidence of that after six decades of routine use, the AAP noted.
Some parents are concerned it might cause cancer based on a 1990 study that found an association, but several larger studies conducted since then have found no evidence of a link, the AAP emphasized in its policy statement.
“It’s similar to some of the concerns about vaccines and autism. This was something that was really pretty thoroughly debunked and that we have zero concern about,” Danziger said.
Some families also question the rationale for the vitamin K injection in the belief that perhaps there’s a reason babies are born with a vitamin K deficiency, so medicine shouldn’t intervene. But there is no evidence of that, Danziger noted.
Some parents balk at having their newborn get an injection and ask that vitamin K be given by mouth, but that option is not as effective as the shot and no oral product has been approved by the U.S. Food and Drug Administration for newborns, the AAP noted.
Similar to vaccine hesitancy, there don’t seem to be many effective strategies to change parents’ minds about vitamin K, Danziger said. She also worried very few people are studying the “worrisome” trend. Since there’s no national or state-level tracking of vitamin K deficiency bleeding, doctors are relying on case reports, she said.
Families “must be counseled on the risk of refusal,” the AAP urged, but Danziger finds many parents are already aware of the information but are still skeptical.
“There’s a lot of mistrust of the health care system,” she said. “I don’t fault parents for wanting to learn more or for having questions… (but) we have years and years of strong international evidence around this, and there have not been any concerns.”