Vitamin K is essential for procoagulant factors II, VII, IX, and X. Newborns can be deficient in vitamin K because of low transplacental transfer, limited gut synthesis, low breast milk concentration, and poor gastrointestinal absorption. Vitamin K deficiency (VKD) is classified into early VKD (occurring within 24 hours of birth and primarily caused by maternal medications1), classical VKD (occurring between 2 days and 1 week of life and often presenting as bruising or umbilical bleeding), and late VKD (occurring between ages 1 week and 6 months in breastfed children or those unable to absorb vitamin K). Late VKD carries a 30% to 60% risk of intracranial hemorrhage, which can result in permanent brain damage, seizures, or death.1
Since 1961, the American Academy of Pediatrics has recommended that all newborns receive a single intramuscular dose of vitamin K, which reduces the rate of late vitamin K–deficient bleeding (VKDB, formerly called hemorrhagic disease of the newborn) by 98%.2 However, amid growing public skepticism, parents are increasingly refusing vitamin K injections at birth.3 According to one study, between 2017 and 2024, the proportion of newborns not receiving intramuscular vitamin K increased from 2.9% to 5.2%.3 A Swedish study found that nonreceipt of vitamin K was associated with bleeding epsiodes.4 Whether the increase in vitamin K refusal has been accompanied by a higher incidence of VKD or VKDB in the US is unknown. This study used a large national database of integrated electronic health record data to explore whether the incidence of VKD and VKDB changed between 2017 and 2025.
MethodsData were obtained from Cosmos,5 which draws electronic health record data from health systems using Epic, including more than 2300 hospitals and 50 000 outpatient settings. This cross-sectional study used Cosmos records for all US infants aged 0 to 6 months born at 35 weeks’ gestation or later who received care between January 1, 2017, and December 31, 2025. Outcomes included the first diagnosis of VKD or VKDB as well as intracranial or intracerebral hemorrhages (eTable in Supplement 1). Diagnoses included those within the problem list or during an encounter, admission, or billing occurrence. Incidence rates per 100 000 infants with 95% Wald CIs were reported. This study was exempted from review and informed consent by the Virginia Commonwealth University’s institutional review board because it used deidentified data.
Results
Between 2017 and 2025, 11 000 782 infants aged 0 to 6 months met inclusion criteria; 5 614 663 (51.0%) were male and 3 410 358 (31.0%) were publicly insured. During the study period, 2151 were diagnosed with VKD and 5217 developed VKDB (Table). Between 2017 and 2025, the percentage of newborns who received injectable vitamin K decreased from 97.7% to 95.0%, and the rate of VKD and VKDB at ages 0 to 6 months increased by 215.7% (from 11.8 [95% CI, 9.4-14.2] to 37.3 [95% CI, 34.4-40.3] per 100 000) and 347.1% (from 24.0 [95% CI, 20.6-27.4] to 107.4 [95% CI, 102.4-112.4] per 100 000), respectively (Figure). A total of 61.8% of infants with VKD and 87.8% of those with VKDB were diagnosed within the first week of life. Only 39.7% and 19.2% of infants diagnosed with VKD and VKDB, respectively, received vitamin K. Of those with VKD and VKDB, 6.9% and 2.4%, respectively, had a diagnosis of intracranial or intracerebral hemorrhage.
Discussion
In this study of more than 11 million infants in the US, vitamin K supplementation decreased and diagnoses of VKD and VKDB increased between 2017 and 2025. Although association does not prove causality, the data raise concerns about increased parental rejection of vitamin K injections and potential harm to infants. Intracranial hemorrhages, in particular, can have grave and lifelong consequences for infants. Increases in VKD and VKDB—peaking in 2025—occur against the backdrop of eroding trust in public health in the wake of the COVID-19 pandemic, increasing vaccine hesitancy, and growing parental unease about interventions in newborns.6,7 As with childhood immunizations, vitamin K prophylaxis may be a victim of its own success8; the rarity of VKDB may leave today’s families largely unaware of its grave consequences.
In countries such as France, Germany, the Netherlands, Switzerland, and Canada, oral vitamin K is offered either routinely or alternatively to intramuscular vitamin K.9 Although the oral form can be less effective in preventing late VKD,1 a harm-reduction approach that offers oral vitamin K as a second-line alternative may be warranted in the US if rejection of injectable vitamin K continues
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