Vitamin K Shots and Informed Consent: What Parents Should Know

For decades, the vitamin K shot has been one of the first things to happen after a baby is born, so routine that most parents never thought to question it

Now more of them are. IMA Senior Fellow in Pediatrics Dr. Katherine Welch joined The National Desk to explain what the shot does, why a growing number of parents are asking harder questions about it, and how families can weigh a decision made in a newborn’s first hours.

Welch starts where the science does: babies really are born with low vitamin K, and the shot has prevented a rare but serious bleeding disorder for decades.

Her argument isn’t that parents should refuse it, but that they deserve the full picture, from the black box warning to the additives she says give some families pause to an oral form she describes as nearly as effective when given correctly.

What she’s really making the case for is informed consent: a parent’s right to understand the options and decide for their own newborn.

Transcript

Angela Brown: Some parents are asking more questions about the routine vitamin K shot given to newborns. This shot is not a vaccine, but it’s commonly given shortly after birth to help enable proper blood clotting in babies. Babies are born with low levels of vitamin K. Joining us now to discuss is Dr. Katherine Welch, Senior Fellow in Pediatrics with the Independent Medical Alliance. Thank you so much for joining us.

Dr. Katherine Welch: Good morning. Thank you for the invitation.

Angela Brown: No problem. So much to learn here. You talk about this, so just give us the basics. The reason this shot is given is because babies are born with low levels of vitamin K, and it’s been routine for decades now. Is that basically the reason here?

Dr. Katherine Welch: Yes. It was discovered back in the 1830s, and there’s a syndrome of neonatal or infantile bleeding. There are two forms of vitamin K deficient bleeding. There’s one in the first couple of weeks, which is more common but a little more mild. And then there’s one later on, after a couple of months, that’s more serious.

Angela Brown: I find this so interesting. So are you seeing more parents now questioning whether they should give their child this vitamin K shot? Is that what’s happening?

Dr. Katherine Welch: Yes, absolutely. They’re refusing, or they’re looking at their options.

Angela Brown: Why are there concerns now? Why are these concerns growing?

Dr. Katherine Welch: Well, parents are doing a lot more research on their own, and they’re discovering more about what’s in the shots. There is a risk of vitamin K deficient bleeding, but the shots are not without risk either. I think it goes along with the whole vaccine hesitancy conversation: parents are doing their own research and realizing that while the shot prevents a rare but real risk of vitamin K deficient bleeding, there are also risks to getting it.

Angela Brown: Now, what are the risks versus benefits that you’re weighing at this point in your organization?

Dr. Katherine Welch: As far as the vitamin K shot goes, there is a black box warning, and that has to do with hypersensitivity and some allergic reactions. But there are also things such as polysorbate 80, which is toxic to the brain and crosses the blood-brain barrier. There’s another form that contains Cremophor, which is also a neurotoxin. And there are other things like benzyl alcohol, and parents say, maybe we don’t want to inject that into our baby, even though there is still a risk of bleeding.

Angela Brown: There are a lot of medical terms there that people may not understand. But when you’re a parent, you hear new data. There’s data coming from doctors that kids are 81 times more likely to develop severe bleeding than infants who do not get the shot. How do you respond to that type of data?

Dr. Katherine Welch: I’d have to see the study. The thing about data is that parents are wising up: there’s data, there’s statistics, there’s reporting, and then there’s the actual investigation of the shots. But I have to say there is a definite decrease in the incidence of vitamin K deficient bleeding. Parents also need to be informed about the risks of the shot and the other excipients that come with it, the solubilizers and the stabilizers. Those are the kinds of things parents want full information on, so they can make the most informed decision for their babies.

Angela Brown: Now, this has been recommended for decades, since the 1960s?

Dr. Katherine Welch: Yes.

Angela Brown: So why has it been recommended? Doctors obviously believe this is the best route for parents.

Dr. Katherine Welch: It’s interesting, because the black box warning actually indicates it should be subcutaneous, not an intramuscular shot. There’s a subcutaneous form, but that is not routinely recommended. There’s also an oral form, which, if given exactly according to the instructions, has the same level of efficacy at preventing bleeding as the injectable. The injectable has been recommended because it’s one shot and you’re done. But I want to add that the IM shot still isn’t 100 percent effective at preventing the bleeding. So people just need to know: it’s one shot, it’s more absorbed, but again, there are also some risks.

Angela Brown: This is my final question. What do you want parents to take from this?

Dr. Katherine Welch: I want parents to understand that they should really do their research. Like anything, there’s nothing that’s 100 percent safe and nothing that’s without risk, so there are risks either way. But they really need to understand what’s in these shots, and that there are options, such as oral forms, that can be given and are extremely effective as well, without the risks of the shots.

Angela Brown: So you’re not against the vitamin K shot, or against vitamin K being given, but maybe in a different form or a different way?

Dr. Katherine Welch: Yes, that’s exactly right. The fact that babies are born vitamin K deficient is a feature, not a bug, of God’s design of our bodies. But nothing is perfect. So parents should know there are oral options, and they should understand the proper administration of those oral drops. They can get very close to the same efficacy in preventing vitamin K deficient bleeding.

Angela Brown: Well, thank you so much. We’re going to plug this real quick: for more information on topics like this, just visit imahealth.org. Thanks once again to Senior Fellow in Pediatrics with the Independent Medical Alliance, Dr. Katherine Welch. Thank you so much for joining us.

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