Declining Vitamin K Prophylaxis in Newborns: A Growing Threat to Neonatal Safety

For over 6 decades, a single intramuscular (IM) injection of vitamin K administered at birth has served as a basis of neonatal prophylaxis in the US, effectively eliminating nearly all cases of vitamin K deficiency bleeding (VKDB).

However, research published in JAMA reveals that the proportion of newborns not receiving this life-saving intervention nearly doubled between 2017 and 2024, raising urgent questions for pharmacists, neonatologists, and other health care providers about their role in combating medical misinformation and supporting evidence-based neonatal care.^1,2

Defining Vitamin K Deficiency Bleeding

Newborns are born with critically low vitamin K stores. A variety of factors influence this; vitamin K cannot readily cross the placenta, breast milk contains only minimal amounts, and the neonatal gut has yet to establish the bacterial colonization responsible for endogenous vitamin K synthesis. Without adequate vitamin K, infants cannot produce enough of several coagulation factors, placing them at heightened risk for spontaneous, life-threatening hemorrhage.³

VKDB is classified into 3 types based on timing, including early (within 24 hours of birth), classical (days 2 to 7), and late (2 weeks to 6 months of age). Late VKDB is considered particularly dangerous because it most commonly manifests as intracranial hemorrhage in infants who appear otherwise healthy, often without any preceding warning signs. The case fatality rate for late VKDB is approximately 1 in 5, and among survivors, roughly 2 in 5 experience long-term neurological damage.⁴

A 2026 review published in the International Journal of Molecular Sciences provides a detailed biochemical framework for understanding why late VKDB can occur even in infants who received prophylaxis at birth. The authors emphasize that vitamin K levels naturally decline over the first weeks of life, particularly in exclusively breastfed infants, underscoring the need for ongoing supplementation strategies in high-risk neonates. The review also highlights the value of functional biomarkers, specifically PIVKA-II (Proteins Induced by Vitamin K Absence or Antagonist-II), for detecting subclinical vitamin K deficiency before overt bleeding occurs, a tool with potential implications for neonatal monitoring protocols.⁵

A National Trend Toward Refusal

The JAMA study analyzed more than 5 million births from 403 hospitals across all 50 states and the District of Columbia between January 2017 and December 2024. The researchers found that nearly 200,000 newborns (3.92%) did not receive the IM vitamin K shot during the study period. More alarming was the trajectory: non-receipt rose from 2.92% in 2017 to 5.18% in 2024, a 77% increase over just 8 years.¹

Non-Hispanic White newborns were most likely to go without the injection (4.3%), compared with 3.4% of non-Hispanic Black and 3.3% of Hispanic newborns. Infants delivered vaginally also showed higher rates of non-receipt (4.2%) than those delivered by caesarean section (3.2%). The study could not determine the specific reasons behind non-receipt, but the authors, as well as outside experts, suggest that parental refusal is a primary driver, citing the absence of any major policy changes during the study period.²

Rising anti-vaccine sentiment and pandemic-era public health skepticism are believed to be fueling refusals. Parents often conflate the vitamin K shot with vaccines or cite online misinformation about the necessity or safety of the injection.¹

The Case for Proactive Counseling

The CDC issued updated guidance urging health care providers to discuss the benefits of neonatal vitamin K prophylaxis with expectant parents before they arrive at the delivery room. The agency warns that in the majority of VKDB cases, there are no warning signs before a life-threatening bleed occurs. Pharmacists, who are among the most accessible health care professionals, are uniquely positioned to address parental concerns during prenatal consultations, childbirth education interactions, and newborn medication counseling.⁴

Key messaging points for pharmacists include clarifying that the vitamin K shot is not a vaccine, explaining that IM administration is preferred over oral dosing because neonatal gut absorption is unreliable, and reinforcing that the standard single-dose injection has an established safety record spanning more than 60 years. When parents decline the IM injection, current guidelines recommend a structured oral supplementation regimen as a secondary option, though this approach requires strict adherence and carries a higher risk of late VKDB.⁴

REFERENCES

1. Scott K, Miller E, Culhane JF, et al. Trends in Vitamin K Administration Among Infants. JAMA. 2026;335(3):272-274. doi:10.1001/jama.2025.21460

2. National Institutes of Health. Protective vitamin shots for newborns on decline. NIH Research Matters. January 13, 2026. Accessed May 13, 2026. https://www.nih.gov/news-events/nih-research-matters/protective-vitamin-shots-newborns-decline

3. Eldeib D. Vitamin K shots for newborns declining nationwide. MedPage Today. May 9, 2026. Accessed May 13, 2026. https://www.medpagetoday.com/publichealthpolicy/publichealth/121149

4. Centers for Disease Control and Prevention. How to protect babies from life-threatening bleeding. Updated January 17, 2025. Accessed May 13, 2026. https://www.cdc.gov/vitamin-k-deficiency/hcp/fact-sheet/index.html

5. Perrone S, Beretta V, Raitano V, Cerioni L, Carloni S. Vitamin K Biochemistry and Pharmacokinetics: The Basis of Late Vitamin K Deficiency Intracranial Bleeding in Early Infancy. International Journal of Molecular Sciences. 2026; 27(9):4000. https://doi.org/10.3390/ijms27094000