Tag: mercury

That Black Box Warning on Vitamin K Shots

Vitamin K is not a vaccine, but some parents who plan on skipping or delaying their baby’s vaccines, also choose to skip this shot.

Vitamin K Shots

Given soon after a baby is born, a vitamin K shot is the most effective way to prevent both early onset and late onset vitamin K deficiency bleeding.

“The vitamin K injection is also a supposed safeguard in case your car is involved in a car wreck on the way home from the hospital or birthing center with newborn in tow.”

The Healthy Home Economist on why you should Skip that Newborn Vitamin K Shot

Although vitamin K deficiency bleeding has never been very common, it is often fatal, and it has been known for almost 125 years that it is caused by a temporary lack of vitamin K in newborns and younger infants.

Can’t you just give babies oral vitamin K to prevent this bleeding?

While oral vitamin K can prevent early onset vitamin K deficiency bleeding, which might start from birth to when a baby is about two weeks old, it won’t prevent late onset bleeding, even if you give the recommend three doses on schedule over two months (as they do in some countries). Babies with late onset vitamin K deficiency bleeding might not have symptoms until after they are two weeks old, or as late as 5 or 6 months old, and it can only be prevented with a vitamin K shot.

Can’t you just avoid dropping your baby or getting into a car wreck if you skip the vitamin K shot?

While you will hopefully do that anyway, the truth is that we don’t know why some infants with vitamin K deficiency bleeding develop bleeding in their brains, as it usually isn’t any kind of big trauma.

In 2013, seven babies over a period of eight months had early and late vitamin K deficiency bleeding at the Monroe Carell Jr. Children’s Hospital at Vanderbilt University in Nashville.

Three of them required surgery to remove clots “out of their head” and may “have issues with seizure disorders and will have long-term neurological symptoms related to seizures and developmental delays.”

I don’t think any of them were dropped or were involved in car accidents on the way home from the hospital or birthing center.

All had refused to get their baby a vitamin K shot.

Why Do Parents Refuse Vitamin K???

So why do some parents choose to skip their baby’s vitamin K shot?

There are no toxic ingredients in your baby's vitamin K shot.
There are no toxic ingredients in your baby’s vitamin K shot.

Some parents simply think their baby doesn’t need it, especially if they have an uncomplicated, “gentle birth” at home. Of course that has nothing to do with whether or not your baby develops vitamin K deficiency bleeding days or weeks later. It also doesn’t matter whether or not you plan on getting your baby boy circumcised, although your pediatrician probably won’t do the circumcision if you skip the shot.

Other parents are worried about a possible link to leukemia and childhood cancer, an improbable link that was refuted way back in the 1990s.

And still others are worried about the mercury content of vitamin K shots. Or they are worried about other supposed “toxins” in the shot, that it is a synthetic version of vitamin K, or that the dose is too high.

“There is no evidence to suggest that the small amount of benzyl alcohol contained in Vitamin K1 Injection (Phytonadione Injectable Emulsion, USP), when used as recommended, is associated with toxicity.”

Vitamin K Package Insert

Why are they worried about these things?

Mostly because someone on the Internet told them to be worried about them, even though vitamin K shots are safe, are free of mercury and any other toxins you might really need to be concerned about, and the dose of synthetic vitamin K your baby gets in the shot will not cause an overdose.

Or they might be worried that their baby might get up to 100mcg/L of aluminum with each shot. Of course, since they are only getting 0.5ml with the shot, that only equals about 0.05mcg of aluminum! Although it is an extremely tiny amount, why is it even in there? It is not working as an adjuvant as some would propose (again, vitamin K is not a vaccine), but rather is likely just a byproduct of the manufacturing process. And you can be assured that your baby can quickly, and safely eliminate the small amount from their body.

“…several countries have reported a resurgence of late VKDB coincident with policies promoting the use of orally administered prophylaxis, even with multiple-dose regimens.”

AAP on Controversies Concerning Vitamin K and the Newborn

The shot (which works) is certainly safer than going to a compounding pharmacy for oral vitamin K (which won’t work to prevent all cases of late-onset vitamin K deficiency bleeding).

That’s right – oral vitamin K for babies isn’t even available in the United States.

That Black Box Warning on Vitamin K Shots

And then there is the black box warning in the package insert for vitamin K.

The package insert for vitamin K does include a black box warning, although these severe reactions are extremely rare in newborns who get a vitamin K shot to prevent vitamin K deficiency bleeding.
The package insert for vitamin K does include a black box warning, although these severe reactions are extremely rare in newborns who get a vitamin K shot to prevent vitamin K deficiency bleeding.

Why is it there?

It was found that people could have severe, life-threatening allergic reactions (anaphylaxis) if they got a large dose of vitamin K too rapidly through an IV. This type of dose would usually be given to patients with significant bleeding who were being treated with anticoagulants (anticoagulant reversal).

“Based on a review of the literature, use of parenteral vitamin K1 may result in severe hypotension, bradycardia or tachycardia, dyspnea, bronchospasm, cardiac arrest, and death. These reactions are most consistent with a nonimmune-mediated anaphylactoid mechanism. It appears that intravenous administration is more frequently associated with these reactions and occurs at an incidence of 3 per 10 000 doses of intravenous vitamin K1.”

Jamie N Brown on Characterizing the Severe Reactions of Parenteral Vitamin K1

This is not what happens when babies get their vitamin K shot though, although there is one non-fatal case report of anaphylaxis after a baby in Turkey got a vitamin K shot in 2014.

There are nearly 4 million births in the United States each year.

Almost all of them get a vitamin K shot very soon after they are born.

And yet there are no reports of anaphylaxis in the United States.

There are isolated case reports of anaphylaxis in newborns to other things, including antibiotics, hepatitis B immunoglobulin, total parenteral nutrition (TPN), and atracurium (used in anesthesia) – but not to vitamin K shots.

“Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.”

Vitamin K Black Box Warning

That’s why most parents don’t skip getting their baby a vitamin K shot. Or they come to regret the decision if they do.

“What it comes down to is that giving your child a shot of Vitamin K at birth is a small price to pay, especially when the cost of rejecting the shot can be severe brain injury and death. I can’t change what happened to Olive, but I can try to prevent it from happening to another baby.”

Olive’s Story

For most parents, avoiding the serious risk of vitamin K deficiency bleeding justifies their baby getting a vitamin K shot.

And that’s why vitamin K deficiency bleeding is so rare these days – at least among those babies whose parents didn’t choose to skip their vitamin K shot.

What To Know About That Black Box Warning on Vitamin K Shots

For most parents, avoiding the serious risk of vitamin K deficiency bleeding easily justifies their decision to get their baby a vitamin K shot, despite the presence of a black box warning.

More About That Black Box Warning on Vitamin K Shots

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