Deciding Whether and How to Give Your Newborn Vitamin K

Introduction

Families have several important medical decisions to make at the birth of a child. One of these important decisions is whether and how to give vitamin K to their newborn. Vitamin K is offered as a prevention against a bleeding disorder called ‘haemorrhagic disease of the newborn’ (HDN) or ‘vitamin K deficiency bleeding’ (VKDB). It is not known which babies will develop HDN (or why) so they offer treatment to all babies. The occurrence of HDN is very low but for babies who get it, it can be fatal.

The most common guidance in the US is to give an intramuscular vitamin K shot to all newborns within hours of birth. Parents can chose the shot, oral supplementation, or skip entirely.

In this post I’ll share my experience as a mom, suggestions for how you can make a decision with your healthcare provider, and I’ll open some questions surrounding healthcare information.

My experience with informed consent

Before the birth of my first baby, we asked the doctor (OB-GYN) for more details on the Vitamin K shot to help us decide whether to inject our baby. The gist of what she said was “I’d do it, it’s just a vitamin“.

At the time, I did a little more research online but I didn’t spend too much time researching this one since I didn’t find many conflicting opinions early on (and as a first-time mom, I had A LOT of other topics on my plate to learn about in the finite period of time leading up to birth!).

Ahead of the birth of our second baby, our midwife brought this choice up again. She gave information that wasn’t previously offered to me. Paraphrasing her: “Vitamin K levels are low in newborns. If we supplement we can reduce the risks of internal bleeding, if it happens. You can do this with the shot or with oral supplementation. The shot contains aluminum”.

She said “aluminum” in a negative tone.

By this point, I had read up on issues with aluminum neurotoxicity; it was a dirty word to me too. I felt shocked, angry, and regretful that this wasn’t known to me before we injected my first. Especially since the oral supplementation is available and similarly effective when followed to completion^{1 2}.

For my second baby, we did proceed with the oral supplementation (this product on Amazon).

Informing myself

Is there aluminum in the shot?

We went with the shot for my first baby because all of the information we had indicated no risk. No risks were indicated from my doctor or from authoritative articles online. For example, I know I read this Evidence Based Birth (EBB) article that led me to believe the shot is harmless. It offers the ingredients for the “preservative-free” shot and explains why they’re not to be worried about.

But now my midwife is saying there IS risk. There is aluminum exposure.

Could it be that my midwife was misinformed?

A quick search showed she wasn’t. The vaccine manufacturer (Pfizer) printed it in the Vitamin K insert for their shot: “This product contains aluminum that may be toxic.”³,⁴

[N.B. This confused me a bit because earlier in the same document they don’t list Aluminum as an ingredient. I saw in a forum someone mentioned that the FDA doesn’t require the disclosure of aluminum in the ingredients list. I still plan to verify this myself & will update once I do.]

Insights from product inserts

Now that I’m digging deeper and taking a look at a few of the available product inserts⁵, several important questions stand out to me, especially where there appears to be a mismatch between the guidance I received from doctors and consumer-focused authoritative articles vs. the product insert.

ALL of these product inserts list adverse reactions, many are serious

Pfizer included a note that “Deaths have occurred after intravenous and intramuscular administration (see Box Warning).“⁶ I didn’t see “death” (or the other severe adverse reactions) listed anywhere on the authoritative articles written for parents (EBB, CDC) and certainly didn’t hear it listed as a risk from my doctor or the hospital.

What is the likelihood that each of these adverse reactions might happen to our newborn?

I expect the severe adverse reactions are quite low occurrence; but even so, shouldn’t these have been mentioned by the hospital to have given us fully informed consent?

Product inserts have a strong recommendation against intramuscular administration

The top medical organizations recommend intramuscular^{7 8} administration. But the Pfizer product insert says (quite strongly!) to avoid it. Only proceed with intramuscular when “the serious risk involved is considered justified”.

How do we explain this mismatch?

How serious is the risk?

Product inserts indicate the shot can contain aluminum and benzyl alcohol, both pose significant threat to babies

I have to wonder why aluminum and benzyl alcohol are not mentioned in the EBB article. Is it an unintended miss, unintentional bias, or intentional evasion?

In the CDC online documentation about Vitamin K, they do address benzyl alcohol but not aluminum. They tell us benzyl alcohol is not to be concerned about, the shot is safe⁹.

The product inserts claim that both are a serious risk of taking this medication.

Product inserts indicate that vitamin K excess can cause jaundice

“Hemolysis, jaundice, and hyperbilirubinemia in neonates, particularly those that are premature, may be related to the dose of Vitamin K1 Injection.”¹⁰

I’m calling this out because my first baby had jaundice while my second didn’t. My first had the shot while my second did the oral drops. I don’t know with how much total vitamin K each baby received. I expect the body will handle it differently depending on how it enters the body (i.e. shot vs. by mouth).

Could the shot have caused or contributed to my first baby’s jaundice?

Long term studies indicate worse health outcomes for VitK shot

The Control Group study¹¹ indicates that infants who received the Vitamin K shot or the mom received vaccinations while the baby was still in utero, but no other vaccinations, still have a higher risk of chronic illness than babies who didn’t. Almost 6% chance of 1 chronic illness and 1% chance of 2 chronic illnesses (although lower rate than if they had additional vaccines).

Questions & Takeaways

Questions to facilitate discussion with your provider

If you are facing this decision soon, here are questions you could use to facilitate discussion with your healthcare provider(s):

1. What is the likelihood my baby will have a bleeding issue?
   • Are there any special risk-factors?
   • Given that my baby will have [some known health concern or upcoming operation, like circumcision] would this impact our treatment plan to prevent bleeding?
2. If we don’t take preventative action, what would happen if the baby does have a bleeding issue? What would treatment look like?
3. What are all of the preventative options available? (shot, oral drops, others?)
4. What are the risks of each preventative option?
   • Can you share any data for the possible adverse effects?
   • How long do we need to monitor the baby to ensure he doesn’t have one of the adverse effects? And if she does, what is the treatment plan?
   • Are there any substances of concern, like aluminum or benzyl alcohol?
5. If we go with the shot – which brand would we be using?
   • Can you please share the product insert?
   • How long has this product been on the market?
   • How are adverse effects reports collected and shared?
6. If we go with the shot – how big of dose do you recommend and how will it be administered (intramuscular?)?
7. If we go with the shot – do you have a preservative-free option? What is it called and could you please share the product insert?
8. If we go with the oral drops – do you have these available or should I buy them myself and bring them to the birth? What would be your recommended dosage and timing?

As parents, we need to do our best to fully understand the risks and benefits of all options and then make the call that best suits our family situation and preferences. If something happens to our baby, it’s usually our fault. Regardless of how informed we actually are, we consented to the treatment (or non-treatment). (Exceptions exist, of course. For example, if there is a mandate for treatment or neglect to offer a treatment.)

Research questions

As a mom, I have to make choices with the data available to me. Although, after digging in deeper on this topic, I have a few unanswered questions.

• Why isn’t it common practice to give patients (or guardians) the product insert BEFORE agreeing to a medical intervention?
• Why are the warnings reported in the product inserts misaligned with the information shared out to parents? For example: warning against intramuscular administration, adverse effects.
• Why is it that the Pfizer insert says the shot includes aluminum but there is no mention in the CDC or EBB explainers?
• I’ve read that aluminum is a problem because it accumulates over time and it’s neurotoxic. Do our safety studies for drugs account for adverse effects in the long-term?
• Why doesn’t the CDC mention the oral option at all?¹²
• Did nature get it wrong?¹³ Is it possible God designed newborns to have low vitamin K for some other reason? Or perhaps His design is for newborns to have more vitamin K but some other intervention/environmental cause is causing a deficit? Maybe the meta question here is: are we treating the root cause or the symptom?
• Is the jaundice rate higher in infants who get the Vit K shot vs. oral drops vs. no treatment?
• Vit K shot isn’t a vaccine, so we don’t have any self-reporting in VAERS. Can we establish a similar (but better) system to collect mass surveillance on drug impact to give consumers transparency?

What would I do next time?

If I am blessed with a third child, how would I proceed? With the information available to me today, I would go with the oral drops again.

Here’s my thinking:

• Although the likelihood of my baby getting HDN/VKDB is very low (est. 0.009%)¹⁴, and we don’t know why it happens, the risks of the oral drops is also very low¹⁵.
• The oral drops appear to be similarly effective as the shot.¹⁶
• I would rather give my baby oral drops than risk the very low chance of a serious bleed.
• The shot is painful, so I prefer oral drops.
  • “IM injection is likely to be painful”¹⁷,¹⁸
• The shot includes aluminum, “that may be toxic”¹⁹

That said, there are plenty of valid reasons parents may go a different way (for example, if you believe you’re likely to forget to complete the oral dosage over time). It’s completely your choice and I respect that choice. We are each doing our best to get optimal health outcomes for ourselves and our families.

Interesting aside: The Bible, Circumcision, & Vitamin K

If you have had a baby boy and taken him to get circumcised, its very likely the doctor will have asked (or insisted) that he had the Vitamin K shot. It makes sense, right? By doing a minor procedure that causes bleeding, there would be significant risk to the infant if he isn’t able to have his blood clot.

“For the generations to come every male among you who is eight days old must be circumcised…” Genesis 17:12 NIV

Fun fact: If you circumcise your baby during the first 3 days as it is routine in some hospitals (or used to be) the baby will not naturally have enough vitamin K in their system (i.e. without supplementation). However, if you wait until day eight (as God specifies), the infant who has breastfed for at least five to seven days will have built up enough vitamin K naturally to allow blood clotting to withstand circumcision!²⁰

What was your experience?

Did your provider give you informed consent and understanding of all the options? Any questions you have on this topic? Please comment below!

Disclaimer: We care deeply about you and your health outcomes but we are in no way responsible for them. We offer this article for information and entertainment, it is not personalized medical advice to you and it is not a substitute for your wellness/medical provider. Please consult your healthcare provider for medical advice.

References & footnotes

Evidence Based Birth “Evidence for the Vitamin K Shot in Newborns” evidencebasedbirth.com/evidence-for-the-Vitamin-K-shot-in-newborns/

Jullien S. Vitamin K prophylaxis in newborns. BMC Pediatr. 2021 Sep 8;21(Suppl 1):350. doi: 10.1186/s12887-021-02701-4. PMID: 34496783; PMCID: PMC8424792. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424792/

Sara Wickham, Vitamin K Articles https://www.sarawickham.com/topic-resources/a-decade-of-vitamin-k-articles/

1. “From older trials and surveillance data, it seems that there is no significant difference between the intramuscular and the oral regimens for preventing classical and late HDN, provided that the oral regimen is duly completed.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424792/ Accessed on January 15, 2024 ↩︎
2. “Surveillance data shows that both the shot and the 3-dose regimen of 2 mg [taken orally] get the incidence of late VKDB down to fewer than 1 in 100,000 births.” https://evidencebasedbirth.com/evidence-for-the-vitamin-k-shot-in-newborns/ Accessed on January 15, 2024 ↩︎
3. https://childrenshealthdefense.org/protecting-our-future/vitamin-k-shots/ ↩︎
4. https://www.pfizer.com/products/product-detail/vitamin_k ↩︎
5. Product inserts: Pfizer, AquaMEPHYTON, MEPHYTON ↩︎
6. https://labeling.pfizer.com/ShowLabeling.aspx?id=5392 ↩︎
7. “The Vitamin K1 injection, given as a shot in the muscle (IM = intramuscular) is the preferred method [in the US]” https://evidencebasedbirth.com/evidence-for-the-vitamin-k-shot-in-newborns/ Accessed on January 15, 2024 ↩︎
8. See table 1. Lippi G, Franchini M. Vitamin K in neonates: facts and myths. Blood Transfus. 2011 Jan;9(1):4-9. doi: 10.2450/2010.0034-10. Epub 2010 Sep 13. PMID: 21084009; PMCID: PMC3021393. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3021393/ Accessed on January 16, 2024 ↩︎
9. CDC “Frequently Asked Questions (FAQ’s): Vitamin K and the Vitamin K Shot Given at Birth” https://www.cdc.gov/ncbddd/vitamink/faqs.html Accessed on January 16, 2024 ↩︎
10. https://labeling.pfizer.com/ShowLabeling.aspx?id=5392. Accessed on January 16, 2024 ↩︎
11. RE: The Control Group Study. “Got Cancer? If you’ve never been vaccinated, you don’t have cancer.” Joy’s Newsletter on Substack. Accessed on Oct 3 https://ghostofjfk.substack.com/p/got-cancer-if-youve-never-been-vaccinated ↩︎
12. CDC “Frequently Asked Questions (FAQ’s): Vitamin K and the Vitamin K Shot Given at Birth” https://www.cdc.gov/ncbddd/vitamink/faqs.html Accessed on January 16, 2024 ↩︎
13. Referencing Sara Wickham’s excellent question on whether nature got it wrong. https://www.sarawickham.com/topic-resources/a-decade-of-vitamin-k-articles/ Accessed on January 16, 2024 ↩︎
14. “Among infants who had not received vitamin K prophylaxis at birth, the incidence of HDN was estimated at 35 (10.5 to 80) per 100,000 live births, being lower in high income countries at 8.8 (5.8 to 17.8) per 100,000 live births”. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424792/ Accessed on January 15, 2024 ↩︎
15. I’m not able to find any statement of risk on the product itself or the Amazon product page. I’m sure anything in excess can harm the body. Vitamin K is something humans are meant to consume from food and all of the ingredients listed on the bottle are edible (Vitamin K, water, gum arabic, sesame seed oil). ↩︎
16. “All newborns should receive vitamin K prophylaxis, as it has been proven that oral and intramuscular prophylactic vitamin K given after birth are effective for preventing classical HDN. There are no randomized trials looking at the efficacy of vitamin K supplement on late HDN. There are no randomized trials comparing the oral and intramuscular route of administration of prophylactic vitamin K in newborns. From older trials and surveillance data, it seems that there is no significant difference between the intramuscular and the oral regimens for preventing classical and late HDN, provided that the oral regimen is duly completed.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424792/ Accessed on January 15, 2024 ↩︎
17. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8424792/ Accessed on January 15, 2024 ↩︎
18. This article also says: “The rationale for the substitution of the IM route by an alternative oral route has to be seen from the child rights convention perspective” I believe this is saying we should honor the personhood and rights of the newborn. We shouldn’t inflict pain unnecessarily. Couldn’t agree more, especially on their first birthday. ↩︎
19. Pfizer insert for vitamin K shot https://labeling.pfizer.com/ShowLabeling.aspx?id=5392 Accessed on January 15, 2024 ↩︎
20. Source: Rex Russell, M.D. “What the Bible Says About Healthy Living”; 2006 second edition. Page 20-21. ↩︎