The success of vitamin K prophylaxis has been so dramatic that many practitioners have never seen an infant afflicted with "Hemorrhagic Disease of the Newborn", now known as "Vitamin K Deficient Bleeding". It is a popular trend in some areas to refuse prophylaxis in an effort to keep things "natural" for the infant, however, it is important to keep in mind that the infants most at risk for the classic form of the disease are healthy babies who are exclusively breastfed.
Vitamin K Deficiency Bleeding (aka “Hemorrhagic Disease of the Newborn”) can result
Incidence of VKDB reported varies from 1.5% to 0.001% , depending on population studied and feeding patterns (formula is protective since it’s supplemented with vit K)
2 – 4mg PO vitamin K after first feeding then 2mg at 2 – 4 weeks and again at 6 – 8 weeks OR
2 – 4mg PO vitamin K after first feeding then 2mg within first week and weekly while breastfeeding OR
2mg PO vitamin K after first feeding then 2mg within first week followed by 25mcg daily for 13 weeks
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there is no licensed PO form in US, but parental form can be given orally
in countries that have gone to PO prophylaxis, failures (even with good compliance) have been reported . Failures have not been reported with IM prophylaxis.
since multiple doses are required, compliance is an issue
advise parents regarding the increased risk of VKDB (exact numbers are unknown)
maternal dietary changes have little effect on overall vitamin K status of newborn
maternal vitamin K supplements of 5mg/day (800% RDA) has been shown in one study to raise infant serum levels to near formula-fed levels, but there is no FDA approved MVI that contains this amount of vitamin K
One study published in the British Medical Journal in 1990 raised this concern, suggesting that the risk of cancer was doubled in babies who received vitamin K at birth
Many studies since then in Europe and in US have refuted this claim and found no association between the two. Only one other study (aside from 1992 paper from the same author) suggested a possible association between vitamin K and the risk of ALL.
There is good consensus among experts that IM vitamin K prophylaxis is safe and is not associated with childhood cancer.
Does vitamin K cause jaundice?
There were reports of hemolytic anemia and hyperbilirubinemia severe enough to cause kernicterus in the mid 1950s with high doses (50mg) of vitamin K2 (menadione). As a result, use of this form of vitamin K was abandoned. We now give infants vitamin K1 (phytonadione). Vitamin K1 has been associated with hyperbilirubinemia only in high doses (25 – 30mg) particularly in premies, though the effect was present to a lesser degree in term infants. This has not been a problem at therapeutic doses, though this concern is why we give babies <1500g a smaller (0.5mg) dose.
What other side effects have been reported?
Anaphylaxis, though most common after IV infusion, has rarely been reported with IM injection
Scleroderma-like patch at the site of injection has been reported primarily in adults after repeated injections, though there are reports of 7 infants with similar dermatologic reactions (again, millions of doses are given without problems)
Ross, JA, Davies SM. Vitamin K prophylaxis and childhood cancer. Med Pediatr Oncol. 2000 Jun;34(6):434-7.
Cornelissen, M., et al. Prevention of vitamin K deficiency bleeding: efficacy of different multiple oral dose schedules of vitamin K. Eur J Pediatr. 1997 Feb; 156(2):126-30.
Greer, FR, et al. Improving the vitamin K status of breastfeeding infants with maternal vitamin K supplements. Pediatr. 1997 Jan;99(1).
