Infant Vitamin K Injection


downloadWhy are babies given a Vitamin K injection at birth?

The human newborn are for un-explainable reasons born with insufficient vitamin K levels which is essential for blood clotting. The Canadian Pediatric Society (CPS) recommends that Vitamin K1 should be given as a single intramuscular dose of 0.5 mg (birthweight 1500 g or less) or 1.0 mg (birthweight greater than 1500 g) to all newborns within the first 6 hours after birth. This is to avoid hemorrhagic disease of the newborn (HDNB) which presents as unexpected bleeding, often with gastrointestinal hemorrhage and ecchymosis, and, in many cases, intracranial hemorrhage. The risk factors for HDNB include; Preterm delivery, low birth weight, a forceps or vacuum extraction delivery, mother’s use of antibiotics, anticoagulants, anticonvulsants, and some other medications during pregnancy, undetected liver disease, extremely fast, or extremely prolonged labor, particularly during the pushing phase, and delivery by Cesarean section.

At five days of age, there is no difference between a blood measurement of vitamin K via the oral or intramuscular route but between 4-6 weeks, biochemical signs of vitamin K deficiency are observed in up to 19% of infants given 2.0 mg of vitamin K orally at birth; by comparison, only 5.5% of those given 1.0 mg intramuscularly have biochemical signs of vitamin K deficiency. For this reason the CPS recommends against oral vitamin K. However, the CPS does not pay heed to the alternate treatment of multiple, sustained oral vitamin K doses.

What is wrong with giving the vitamin K injection to newborns?

Vitamin K is necessary, but there are much gentler, noninvasive ways of providing an infant with adequate vitamin K. Despite the pain and trauma to the newborn just hours after birth, the amount of vitamin K injected into newborns is 20,000 times the needed dose. The injection also contains preservatives that can be toxic for your baby’s delicate, young immune system. The manufacturer’s package insert states that “Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may be related to the dose of Phytonadione” and “severe hypersensitivity reactions, including anaphylactoid reactions and deaths have been reported following parenteral administration; hyperbilirubinemia has been observed in the newborn following administration of Phytonadione”.

imagePotential risks of vitamin K injection are jaundice, flushing, rash, or a mild reaction at the injection site. The inactive ingredients listed on the manufacturer’s package insert include; Polyoxyl 35 Castor Oil (used in the manufacturing of soaps, lubricants, hydraulic and brake fluids, paints, dyes, coatings, inks, cold resistant plastics, waxes and polishes, nylon, pharmaceuticals and perfumes), Dextrose Monohydrate (this natural sugar has been used as a sweetening and texturizing agent, or as a fermentation substrate), Water, Benzyl Alcohol (used as a genera solvent for inks, paints, lacquers and epoxy resin coatings), and Hydrochloric Acid (used in the chemical industry as a chemical reagent in the large-scale production of vinyl chloride for PVC plastic, and MDI/TDI for polyurethane). Other brands such as Hospira Inc also contain aluminium; “Warnings: This injection should be administered subcutaneously (just under the skin) because severe reactions including fatalities have occurred immediately after intramuscular (deep muscle) and intravenous injection (via a drip). Those reactions include hypersensitivity, anaphylactic shock, and cardiac and respiratory arrest. Benzyl Alcohol as a preservative as been associated with toxicity in newborns”.

Is there any evidence against the vitamin K injection?

The World Health Organization (WHO)  recommends that “administering vitamin K to the baby if country policy prescribes it, either by injection or orally. However, the evidence for routine administration of vitamin K to all newborns to prevent the relatively rare haemorrhagic disease of the newborn is still lacking.” This is quite intriguing, since many developed countries choose routine vitamin K injections despite lack of evidence to support such a practice as stated by the WHO; “Practices for which insufficient evidence exists to support a clear recommendation and which should be used with caution while further research clarifies the issue: Routine administration of vitamin K to all healthy newborns or to all newborns that will be breastfed.”

It has been observed that vitamin K deficiency is not reported in the literature before the modern practice of premature cutting of the umbilical cord at birth, suggesting that it is the premature cutting or clamping of the umbilical cord that can contribute to vitamin K deficiencies in newborns.

As early as April 17, 1977, an article by Van Doorm et al. in one of the world’s most esteemed medical journals, the Lancet, discredited the policy of routine vitamin K injections; “We conclude that healthy babies, contrary to current beliefs, are not likely to have a vitamin K deficiency.. the administration of vitamin K is not supported by our findings.” There has been much peer-reviewed evidence generated which questions the efficacy of routine vitamin K injections as sound public health policy.

The current Dutch vitamin K practice guideline consists of prophylactic administration of 1 mg vitamin K orally directly after birth and a daily dose of 25 μg from day 8 onwards. The current prophylactic treatment provides good protection against HDNB for healthy, breastfed infants. However, the current prophylactic treatment provides insufficient protection for a specific group of infants, namely breastfed infants with defective fat absorption, leading to less efficient absorption of vitamin K by the body. Anually approximately 5 infants from this group suffer serious haemorrhage. After evaluation of current literature and advice from The Health Council of the Netherlands, vitamin K dosage was adapted for all breastfed infants from day 8 to 3 months (12th week of life) following birth: the daily dose was raised from 25 µg to 150 µg per day. According to Dr. Cees Vermeer, PhD, Associate Professor of Biochemistry at the University of Maastricht (in The Netherlands), the world’s leading specialist in vitamin K, “Vitamin K shots are completely unnecessary for your newborn.”

imagesHow do we give oral vitamin K to our baby?

Oral vitamin K is safe and equally as effective as intramuscular vitamin K. Because oral vitamin K is not as well absorbed as intramuscular vitamin K, a higher dose must be given.

Vitamin K stores can also be built up during pregnancy if the mother increases vitamin K rich foods in her diet and/or takes a vitamin K supplement. This also applies to breastfeeding since vitamin K transmits to breast milk.

My Conclusion

Given that the incidence rate of vitamin K deficiency is only 1 per 100 000 infants and the evidence against routine vitamin K injections, vitamin K supplementation is not entirely necessary. If you and your baby are free from risk factors and your baby is full term and healthy, there is no necessity of vitamin K supplementation at all. If you are worried or you present with any risk factors listed above, opt for oral vitamin K.




Canadian Pediatric Society:

World Health Organization:

Vitamin K Injection:

Van Doorm J, Muller A. and Hemker, H. Heparin-like inhibitor, not vitamin-K deficiency, in the newborn (letter). Lancet 1977;i:852-3.

McMullin, D. (1996). Administration of Vitamin K to Newborns: Implications and Recommendations. Canadian Medical Association 154(3).

de Winter JP, Joosten KF, Ijland MM, Verkade HJ, Offringa M, Dorrius MD, van Hasselt PM; Spaarne Ziekenhuis, afd. Kindergeneeskunde.
Ned Tijdschr Geneeskd. 2011;155(18):A936.

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