Purpose of the Vitamin K Shot
The vitamin K shot helps prevent VKDB (vitamin K deficiency bleeding) in infants.
Babies are born with insufficient levels of vitamin k, which they need in order to stop life threatening and spontaneous bleeding. This bleeding can occur anywhere inside or outside of the body, but when the bleeding happens on the inside it can be extremely difficult to notice.
The Vitamin K shot enters the bloodstream and immediately increases the amount vitamin K in the blood. This provides enough so that the baby’s levels don’t drop dangerously low in the first few days of life.The rest of the vitamin K is released slowly over the next 2-3 months, providing a steady source until the baby has another source from their diet (cdc.gov/ncbddd/vitamink/faqs.html).
Is the Vit K Shot a Vaccine?
No. Vaccines train the body to prevent sicknesses before they start. This is done by introducing an antigen into the body that imitates an infection, triggering the immune system to respond. The Vitamin K shot does not trigger the immune system.
Misconceptions About the Black Box Warning
This is probably one of the top concerns about the vitamin k shot. Yes, it does come with a black box warning. BUT it is referring specifically to its use as an antidote for too much Coumadin or Warfarin (blood thinning medications) given to adults in large doses to combat hemorrhages.
It was found that people could have severe allergic reactions (anaphylaxis) if they received too high of a dose too rapidly intravenously. The dosage given to newborns doesn’t come close to the high dosages given to these adult patients, and is given subcutaneously not intravenously. There have been zero official reported cases of vitamin k shots causing infant deaths, and only one official reported case of an allergic reaction after decades of use in millions of babies.
Sources:
Vitamin K Deficiency Bleeding Stats
Early VKDB is the most common, occurring in 1 in 60 to 1 in 250 newborns. Late VKDB is rarer, occurring in 1 in 14,000 to 1 in 25,000 infants (1-3).
Infants who do not receive a vitamin K shot at birth are 81 times more likely to develop late VKDB than infants who do receive a vitamin K shot at birth (4).
Sources:
Hand I, Noble L, Abrams SA; AAP Committee on Fetus and Newborn, Section on Breastfeeding, Committee on Nutrition. Vitamin K and the Newborn Infant. Pediatrics. 2022;149(3):e2021056036
Zipursky A. Prevention of vitamin K deficiency bleeding in newborns. Br J Haematol 1999;104:430–7.
Sutor AH, Kries R, Cornelissen EAM, McNinch AW, Andrew M. Vitamin K deficiency bleeding (VKDB) in infancy. Thromb Haemost 1999;81:456–61.
4. McNinch AW, Tripp JH. Haemorrhagic disease of the newborn in the British Isles: two year prospective study. BMJ 1991;303:1105–9.
Alternative: Oral Vitamin K (Data & Research)
If you choose to decline the shot, there is an oral option. There is some research to show that the oral route may be effective in preventing early/classic VKDB (1-3).
But there are concerns about its ability to prevent late-onset VKDB.
The AAP released a statement in 2003 citing multiple reports of late-occurring VKDB in countries that established policies of oral prophylaxis of infants, with a single oral dose of vitamin K after birth shown to be less effective than a parenteral dose (4).
“In a Swiss study using 2 oral doses of 2 mg of vitamin K on day 1 and day 4, late-onset VKDB was rare but still occurred, with an incidence of 3.79 per 100 000, and a 3-dose schedule was subsequently recommended (5-6).”
Sources:
1-3
Schubiger G, Tönz O, Grüter J, Shearer MJ. Vitamin K1 concentration in breast-fed neonates after oral or intramuscular administration of a single dose of a new mixed-micellar preparation of phylloquinone. J Pediatr Gastroenterol Nutr. 1993;16(4):435–439
McNinch AW, Upton C, Samuels M, et al. Plasma concentrations after oral or intramuscular vitamin K1 in neonates. Arch Dis Child. 1985;60(9):814–818
O’Connor ME, Addiego JE Jr. Use of oral vitamin K1 to prevent hemorrhagic disease of the newborn infant. J Pediatr. 1986;108(4):616–619
4 Cornelissen M, von Kries R, Loughnan P, Schubiger G. Prevention of vitamin K deficiency bleeding: efficacy of different multiple oral dose schedules of vitamin K. Eur J Pediatr. 1997;156(2):126–130
5-6
Schubiger G, Berger TM, Weber R, Bänziger O, Laubscher B; Swiss Paediatric Surveillance Unit. Prevention of vitamin K deficiency bleeding with oral mixed micellar phylloquinone: results of a 6-year surveillance in Switzerland. Eur J Pediatr. 2003;162(12):885–888
Vitamin K Shot Alternative
Can I Just Eat a Rich Vitamin K Diet During Pregnancy?
Currently, there is no substantial evidence that a mother taking extra Vitamin K during pregnancy can prevent VKDB in infants.
A 2018 systematic review and meta-analysis researched over 21,000 pregnant women from the US, UK, Netherlands, and Japan. Mothers assigned to take Vitamin K during pregnancy (dosing and durations ranging from 1 mg/day for 4 weeks versus 50 mg IM between 4-12 hours before birth) were compared to women who were not.
The results found improvement in maternal Vitamin K levels, including in breastmilk and newborn cord blood, but no difference in newborn bleeding.
Source:
Shahrook S, Ota E, Hanada N, Sawada K, Mori R. Vitamin K supplementation during pregnancy for improving outcomes: a systematic review and meta-analysis. Sci Rep. 2018 Jul 30;8(1):11459. doi: 10.1038/s41598-018-29616-y. PMID: 30061633; PMCID: PMC6065418.
Vitamin K: Shot vs Oral
There is no proven oral version of Vitamin K available for infants in the U.S.
The shot is absorbed more easily than the oral version.
The shot has a delayed release effect that protects against both classical and late bleeding.
When the shot is used, the chance of late VKDB is near zero (1).
If going to choose the oral route, the 3-dose regimen of 2mg is preferred as It lowers the chance of VKDB to less than 1 in 100,000, but does not eliminate it as well as the shot (2).
Infants with underlying (and sometimes undetected) gallbladder or liver disorders may not be able to absorb the oral Vitamin K when it is given in a 3-dose regimen, and would be better served by the shot. Sources:
1 Puckett and Offringa 2000; Shearer 2009
2 Mihatsch et al. 2016
Alternative: Oral Vitamin K (Dosing Recommendations)
The following stats are based off late VKDB, rarer than early but can be extremely serious.
1-3 mg at birth: 1.4-6.4 out of 100,000
1mg 3x during infancy: 2.6 our of 100,000
2mg 3x during infancy: 0-0.9 out of 100,000
birth, 4-6 days, 4-6 weeks
2mg after birth and 1 mg every week for 3 months: 0-0.9 out of 100,000.
Sources: Pucket and Offringa, 2000
Vitamin K Shot vs Oral: Pros & Cons
PROS OF SHOT
Highly effective at preventing early AND late VKDB
Vitamin K Is slowly released overtime, which provides enough Vitamin K1 until the baby’s levels reach adequate levels naturally
CONS OF SHOT
More painful, in the moment, when receiving the dose
Can cause bleeding or bruising at the injection site
Can cause bleeding or bruising at the injection site
If the baby has undetected gallbladder or liver disease, the shot still may not protect them from VKDB
Does include low levels of Polysorbate 80 (however, children typically receive far higher doses from food/drinks unfortunately).
PROS OF ORAL
Easier and less painful to give
The 3-dose regimen of 2 mg Vitamin K1 lowers the risk of classical and late VKDB to under 1 per 100,000, but is not quite as effective as the shot (closer to zero).
CONS OF ORAL
Babies experiencing diarrhea, reflux, etc., may not be able to absorb it as well
If the baby has undetected gallbladder or liver disease, a 3-dose regimen of oral Vitamin K may not protect them as well as the shot
Requires the parental commitment of giving the adequate doses
Click here to learn more about if the Vitamin K shot causes jaundice.
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