Injectable Vitamin K1 vs. Oral Vitamin K1 for Newborns

Expectant parents are increasingly becoming aware that they can request and at times insist on alternative interventions for their infants at birth. Here is a review of one of those alternatives – oral rather than injectable vitamin K1. 

Vitamin K1 is needed at birth to help prevent vitamin K deficiency bleeding (VKDB) since this vitamin does not easily move across the placenta from mom to baby. 

Vitamin K deficiency can cause bleeding into the newborn’s brain with little to no warning. 

The wisdom is why risk this serious complication over the simple administration of the vitamin K1 immediately after birth. According to the CDC, 1 in 60 newborns can be affected. 

Babies can be affected by VKDB until they are 6 months old. VKDB is divided into three types: early, classical and late. The chart below from the CDC helps explain these three different types.

Early and classical VKDB are more common, occurring in 1 in 60 to 1 in 250 newborns, although the risk is much higher for early VKDB among those infants whose mothers used certain medications, like anti-seizure drugs, during the pregnancy. 

Late VKDB is rarer, occurring in 1 in 14,000 to 1 in 25,000 infants. 

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. 

https://www.cdc.gov/ncbddd/vitamink/facts.html

Accordingly, the American Academy of Pediatrics (AAP) recommends that a single intramuscular dose of Vitamin K1 Injection at 0.5 to 1 mg be administered to a baby within one hour of birth. 

As a matter of fact, the American Academy of Pediatrics has a policy statement titled, “Controversies Concerning Vitamin K and the Newborn.” In this paper the AAP recommends the following: 

• Vitamin K1 should be given to all newborns as a single, intramuscular dose of 0.5 to 1 mg.

• Additional research should be conducted on the efficacy, safety, and bioavailability of oral formulations and optimal dosing regimens of vitamin K to prevent late VKDB.

• Health care professionals should promote awareness among families of the risks of late VKDB associated with inadequate vitamin K prophylaxis from current oral dosage regimens, particularly for newborns who are breastfed exclusively.

http://pediatrics.aappublications.org/content/pediatrics/112/1/191.full.pdf

So for families considering oral vitamin K1 as an alternative to the injectable form, the Journal of Pediatrics published in 2008 "One milligram of weekly oral prophylaxis offers significantly higher protection to these infants and is of similar efficacy as 2 mg of intramuscular prophylaxis at birth." 

https://www.ncbi.nlm.nih.gov/pubmed/18381514

Note the “2 mg of intramuscular prophylaxis at birth" in the preceding paragraph. The AAP recommends a single intramuscular dose of Vitamin K1 Injection at 0.5 to 1 mg be administered to a baby within one hour of birth. 

This implies that the one-milligram of weekly oral prophylaxis suggested by the 2008 study in the Journal of Pediatrics offers significantly higher protection to infants than the 1 mg intramuscular dose. 

A 1997 article in the European Journal of Pediatrics finds "A daily low oral dose of 25 micrograms vitamin K1 following an initial oral dose of 1 mg after birth for exclusively breast-fed infants may be as effective as parenteral vitamin K prophylaxis. 

https://www.ncbi.nlm.nih.gov/pubmed/9039517

The literature both here in the USA and in Europe indicates oral vitamin K1 is as effective as injectable vitamin K1 to prevent early, classical and late VKDB if the oral regimen is followed. In other words, parents must administer the oral vitamin K1 as directed to reach the same level of protection as injectable. This places responsibility on the parent to dose at either a daily or a weekly interval for up to 12 weeks.  

The reason a family may choose to take on the responsibility of a daily or weekly oral regimen over a single intramuscular injection of vitamin K1 is the adverse side effect profile. 

Injectable vitamin K1 has a box warning: 

Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration  of phytonadione (injectable vitamin K1.)  Typically these severe reactions have resembled  hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on  receiving phytonadione for the first time. Therefore the  INTRAMUSCULAR route should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified. 

(Of note, the AAP does not recommend a subcutaneous route of administration and therefore hospitals will not administer the med this way to newborns.) 

Other injectable vitamin K1 side effects include: 

• Transient "flushing sensations" as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis. 

• Pain, swelling, and tenderness at the injection site. 

• The possibility of allergic sensitivity including an anaphylactoid reaction. 

• Hyperbilirubinemia  in the newborn. This has occurred rarely and primarily with doses above those recommended. 

Injectable vitamin K1 also has associated warnings: 

• Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection has been associated with toxicity in newborns. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Data are unavailable on the toxicity of other preservatives in this age group. 

• This product contains aluminum that may be toxic. Premature neonates are particularly at risk because their kidneys are immature, and they required large amounts of calcium and phosphate solutions, which also contain aluminum. 

Finally the precautions linked with injectable vitamin K1 are: 

• Studies of carcinogenicity,  mutagenesis or impairment of fertility have not been conducted with Vitamin K1 Injection. 

• Hemolysis,  jaundice, and  hyperbilirubinemia in neonates, particularly those that are premature, may be related to the dose of Vitamin K1 Injection. 

(https://www.rxlist.com/vitamin-k1-injection-drug.htm) 

Now the question is what is contained in oral vitamin K1? The product I recommend contains only vitamin K1-phytonadione, water, gum arabic and sesame seed oil. 

Of course an allergic, or worse an anaphylactic, reaction could occur with any of these ingredients, as with any food item the baby ingests. 

Gum Arabic side effects are an unfavorable viscous sensation in the mouth, early morning nausea, mild diarrhea, and bloating abdomen. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3570285/

A couple oral vitamin K1 caveats do remain though. The injectable may be preferable if the baby is premature and/or is term and ill. In both these circumstances, the baby’s ability to absorb nutrients, like oral vitamin K1, from the GI tract is in question. Second if the baby has biliary issues, and this would not be known at birth, then the absorption of oral vitamin K1 could also be limited. 

After reading the last two pages, parents are understandably electing to use oral vitamin K1 with their babies. The important point to remember is the oral regimen must be followed as directed. 

Make sure you speak with your physician about what is right for your baby and family.

You can find our Vitamin K Drops Protocol in the image below along with other supportive products for infants and toddlers.