Natural Liquid Vitamin K Drop

The Question:

I have been looking for information and a product that I could use for my newborn as a vitamin k supplement. I do not plan to give him the pharmaceutical vitamin k shot or the oral meds they offer. Is it safe to give a newborn a natural liquid vitamin k drop, and also at what dosage would you administer? Is there a product you have or one that you would recommend, if any.

The Answer:

Thanks for your interesting and challenging question.  The conversation about newborn Vitamin K prophylaxis is complex.  It is challenging for parents and clinicians to reconcile the evidence that babies seem to be born “deficient” in such an important vitamin so necessary for blood clotting and prevention of death or brain injury due to internal bleeding. 

Did Mother Nature make a mistake in our seemingly perfect design?

Or is there a reason babies are born with low levels of Vitamin K?

It is clear that Vitamin K does not pass easily through our placenta or to the baby through our breastmilk. Are we interfering with a delicate balance by intervening by giving Vitamin K after birth and inadvertently causing harm?  Without interference and in accordance to the principles of “survival of the fittest”, are a certain number of babies destined to harm or death?  Vitamin K Deficiency Bleeding (VKDB) is rare with a most recent incidence rate (in Europe)  when infants DO NOT receive Vitamin K at birth is 4.4 to 10.5 infants per 100,000.   

Ideally large randomized control trials could have been done to assist us with some of these questions and concerns.   Unfortunately, there was little research done when Vitamin K administration was initiated in 1961.  Collecting evidence about potential harm from Vitamin K injections is therefore limited to more confounding retrospective studies comparing information as practice changed over time.

This is what we think we know about administering Vitamin K to newborns in preventing VKDB:

Injection of 1 ml of Vitamin K intramuscularly (IM) is the most effective way to reduce the risk of all forms of VKDB – early, classical and late.  Although it requires a shot in the leg, it exposes the baby to the least amount of Vitamin K. The incidence of VKDB when infants receive Vitamin K IM is from 0 to 0.62 infants per 100,000.  Infants with liver and bowel issues may still be at risk due to absorption issues.  The limited research has not proven any risks to infants receiving injectable Vitamin K, including leukemia, and there has only been one documented case of allergic reaction.

Some parents still remain concerned about the contents of the pharmaceutical preparations of Vitamin K fearing the possibility of introducing toxins to newborns.  The alternative method of administering Vitamin K is orally.  Research has shown what while oral doses of Vitamin K at birth IS effective at reducing the risk of classic VKDB (bleeding from 24 hours to 1 week sometimes associated with bleeding at the umbilicus and circumcision), it is less effective at preventing late VKDB most commonly attributed to lack of Vitamin K in breastmilk.  It is believed the injectable Vitamin K is stored in muscle for a slow sustained release over time. One of the reasons oral Vitamin K is considered less effective is that babies with gallbladder issues can not absorb the fat-soluble Vitamin K mixture.  When infants receive oral Vitamin K at least three times (usually at birth, one and four weeks) the risk of developing VKDB is anywhere from 1.4 to 6.4 infants out of 100,000. Because injectable Vitamin K reduced the risk of all forms of VKDB – early, classic and late – it has become the standard of care for newborns.  Parents wanting to avoid the discomfort of the injection for their newborns still elect to use oral Vitamin K, however using the FDA-approved oral dosing of Vitamin K does nothing to address the concern of exposing your baby to the carriers and preservatives that may come with this approach. 

Interestingly, when babies receive oral Vitamin K they are given 6 times the amount they would be exposed to if they had been given the one dose of injectable Vitamin K.  Babies are injected with 0.5 ml to 1.0 ml depending on birth weight.  The current recommended dose for oral Vitamin K is 2 ml at birth, 1 and 4 weeks equalling a total of 6 ml of Vitamin K!  This is often a concern for parents wanting to minimize exposure to foreign substances. 

In Canada and the US there NO approved infant Vitamin K supplements specifically for oral consumption, therefore when parents opt to give oral Vitamin K to their newborns, they are given the injectable version orally.

Other countries, such as the Netherlands and Denmark, have oral suspensions approved for initial larger doses at birth then weekly or daily supplementation for the first 3 months. This method of giving Vitamin K is reliant on parent’s compliance with good application (no spit ups and not on an empty stomach) and absorption (no diarrhea, prolonged antibiotic use, cystic fibrosis or liver/ gallbladder issues). There is still ongoing research into the effectiveness of giving Vitamin K orally.  The Netherlands recently increased the recommended daily amount to 150 mcg to match the slightly more effective weekly dosing in Denmark. Denmark had been recommending 1 mg weekly until the year 2000 when the oral suspension was no longer available and they switched to injectable Vitamin K.

There is so much more research needed to be done to be able to address your question of whether there is a “safe” alternative to the more studied “pharmaceutical” brands you are not wanting to give your baby. The liquid Vitamin K supplements on the Canadian and US markets for purchase at health food stores or online have not been studied for quality or effectiveness.  As I was preparing my response to this question, I became curious what a Naturopathic Doctor and Compounding Pharmacist would say. Both echoed my thoughts. 

More research needs to be done

Specifically about the timing and dosage of these products before any claims could be made about their safety. 

It is possible these supplements are just as safe as those approved in Europe but without research and regulation we have no way of knowing. 

I certainly empathize with parents about how challenging the Vitamin K decision can be.  There is seemingly no right answer as each option has disadvantages.  For parents choosing unregulated oral supplements, the disadvantage is the lack of evidence to give any reassurance about safety and effectiveness making it the road less traveled.