Tag: newborns

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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Don’t Skip Your Baby’s Vitamin K Shot

Most parents understand and expect that their baby will get a vitamin K shot when they are born and before they leave the hospital.

It helps prevent bleeding from vitamin K deficiency.

Vitamin K for Babies

Leave the formula samples at the hospital, but don't leave without your baby's vitamin K shot.
Leave the formula samples at the hospital, but don’t leave without your baby’s vitamin K shot.

Newborns have been routinely getting vitamin K shots since at least since 1961.

While it was well known that newborns could suffer from hemorrhagic disease of the newborn (the old name for vitamin K deficiency bleeding) since 1894 (thanks to Dr. Charles Townsend), it wasn’t until later that it was connected to a temporary lack of vitamin K in newborns and younger infants. This occurs because:

  • vitamin K doesn’t pass through the placenta well, so your baby doesn’t build up a good supply during pregnancy
  • breast milk is a poor source of vitamin K, even if the breastfeeding mother eats well and takes supplements, so your baby isn’t able to quickly build up a good supply after she is born
  • babies have a mostly sterile gut and are not born with the bacteria in their intestines that can make vitamin K
  • some clotting factors need vitamin K to work

Although vitamin K deficiency bleeding was never very common, before newborns began it get vitamin K shots, it did affect from 1.7% (classic onset disease) to 7 in 100,000 newborns (late onset disease).

Since many of these bleeds were fatal, even though they were rare, no one thought that there was a benefit to being low in vitamin K and getting a vitamin K shot wasn’t controversial. At least not until a 1992 paper suggested that vitamin K shots could be associated with childhood cancer. That soon led some parents to refuse their babies vitamin K shots for a short time, at least until the link was refuted.

In 1996, a student called for the ‘End of the Vitamin K Brouhaha:’

“Because hemorrhagic disease of the newborn can be life-threatening but preventable, the studies by von Kries et al and Ansell et al should allay our fears and doubts about the dangers of administering intramuscular vitamin K immediately after birth. It seems that hemorrhagic disease of the newborn can be completely eradicated without the threat of leukemia and childhood cancer as a side effect.”

And the vitamin K brouhaha did seem to end.

The Vitamin K Controversy

It came back though.

In addition to holistic and natural parenting groups, there are some who are against vaccines who are also against vitamin K shots.

This is surprising to many people, as those who oppose giving babies vitamin K are often the same folks who push many other types of vitamins, including megadoses of vitamin C, vitamin B12 shots, and extra vitamin D.

Vitamin K Misinformation

So why do some parents skip giving their new baby a vitamin K shot?

It is possible that in doing their research, they have been mislead by some of the misinformation about vitamin K that you commonly find on the internet.

This includes claims that:

  • there is mercury and other toxic ingredients in the vitamin K shots (the truth is that neither mercury or thimerosal nor any other heavy metals are used as a preservative in vitamin K shots and all of the other ingredients are safe too)
  • vitamin K shots cause cancer (the truth is that they don’t and an early study that suggested they did was later refuted many times)
  • babies don’t need extra vitamin K (the truth is that some do though and it is typically impossible to identify them, except maybe for babies born to mothers taking certain medications, mostly seizure medicines, that put them at extra risk of early vitamin K deficiency bleeding)
  • babies start making enough vitamin K when they are 8 days old (the truth is that some babies don’t, especially those with liver disease and other disorders that might interfere with the absorption of fat soluble vitamins)
  • babies did fine before we started giving them vitamin K shots (the truth is that some died, which is why we started giving vitamin K in the first place)
  • you can just give babies oral vitamin K instead of a vitamin K shot (the truth is that oral vitamin K doesn’t work to prevent all cases of late onset vitamin K deficiency, which is also deadly)
  • only boys who get a circumcision need vitamin K (the truth is that we don’t know why some infants with vitamin K deficiency bleeding develop bleeding in their brains, as it isn’t usually any kind of big trauma, so it doesn’t have to be something like a circumcision or a fall or whether you delivered vaginally or by C-section, etc. In fact, late onset bleeding can occur up to 12 weeks, and sometimes as long as 6 months, after a baby is born!)
  • there must be a benefit to having low vitamin K levels when we are born, otherwise God wouldn’t have made us this way (even if this were somehow true, it doesn’t negate the fact that some babies die from their low vitamin K levels…)

Just as with vaccine preventable diseases, since vitamin K deficiency is now rare (because most parents make sure their babies get a vitamin K shot), it is easy for parents to be misled by this type of misinformation.

Bad Advice about Vitamin K

According to the American Academy of Pediatrics, vitamin K deficiency bleeding “is most effectively prevented by parenteral administration of vitamin K.”

That’s the vitamin K shot.

While early (birth to 2 weeks) vitamin K deficiency bleeding can be prevented with either oral vitamin K or a vitamin K shot, late onset (2 to 12 weeks) vitamin K deficiency bleeding is best prevented with a vitamin K shot.

Some people didn’t get the message though, advising parents to skip the vitamin K shot against all standard medical advice:

  • Dr. Mercola still warns parents about the ‘jab with a syringe full of vitamin K.’
  • Sarah Pope at the Health Home Economist tells parents to ‘Skip that Newborn Vitamin K Shot’
  • 28 percent of parents who delivered at local private birthing centers in Tennessee had recently declined the vitamin K shot

So what are the consequences of this kind of non-standard, non-evidence based advice?

They are much as you would expect when dealing with a potentially life-threatening condition – a rise in vitamin K deficiency bleeding in newborns and infants.

Among the recent cases of early and late vitamin K deficiency bleeding include:

  • seven babies over eight months in  2013 at Monroe Carell Jr. Children’s Hospital at Vanderbilt University in Nashville, including three who required surgery to remove clots “out of their head” and who may “have issues with seizure disorders and will have long-term neurological symptoms related to seizures and developmental delays.”
  • a 5-week-old in Florida with late onset vitamin K dependent bleeding. The youngest of 6 children, none of whom had been given vitamin K, the baby had a seizure and stopped breathing after developing two brain hemorrhages.
  • a 3-week-old in Indiana with late onset vitamin K dependent bleeding who was born in a birthing center and whose “parents signed a waiver to forego vaccination and prophylactic therapies,” and required an emergency craniotomy to evacuate braining bleeding, prolonged intubation, and difficult to control seizures
  • a 6-week-old in Illinois with late onset vitamin K dependent bleeding who never received vitamin K prophylaxis at birth and developed brain bleeding and swelling, seizures, a DVT, and who was hospitalized for 10 days
  • a 6-week-old in South Texas with late onset vitamin K dependent bleeding who never received vitamin K prophylaxis at birth and died after developing brain bleeding and seizures
  • an infant in Australia who had not been given a vitamin K shot as per her mother’s birth plan and  died of late vitamin K deficiency bleeding (at 33 days of life)
  • another infant in Australia who is in critical condition after his parents refused a vitamin K shot
  • infants in Germany, Switzerland, Denmark, and the Netherlands who have suffered from vitamin K deficiency bleeding while receiving oral vitamin K, often because their parents refused a vitamin K shot

Tragically, most parents who refuse vitamin K shots also refuse other potentially life-saving medical interventions, including getting a hepatitis B vaccine and even getting erythromycin eye ointment. And many go on to refuse all childhood vaccines.

On the bright side, the great majority of parents do allow their newborn babies to receive vitamin K when they are born. One study found that only 0.3% of parents refused vitamin K.

What To Know About Vitamin K Shots for Babies

The bottom line is that vitamin K shots are a safe way to prevent vitamin K deficiency bleeding. This is no good reason to skip this shot for your baby.

More Information About Vitamin K Shots for Babies

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How to Clean Your Baby’s Umbilical Cord

It is very important that a baby’s umbilical cord is well cared for, as infections of the umbilical cord stump have historically been a major cause of disease and death in newborn babies.

These infections can include funisitis (foul smelling, purulent discharge from the umbilical cord stump), omphalitis (infection of the umbilical cord stump), omphalitis with necrotizing fasciitis (more severe infection with sepsis and shock), and neonatal tetanus.

History of Umbilical Cord Care

Over the years, many things have been used to try and keep a newborn baby’s umbilical cord free of bacterial colonization until it falls off.

“To achieve the goal of preventing omphalitis worldwide, deliveries must be clean and umbilical cord care must be hygienic.”

AAP Umbilical Cord Care in the Newborn Infant – 2016

These substances include:

  • triple dye
  • isopropyl alcohol  or rubbing alcohol
  • povidone-iodine or iodopovidone (Betadine)
  • chlorhexidine
  • hexachlorophane
  • antimicrobial ointments, such as neomycin and bacitracin

Remember when your baby came home from the nursery with his or her cord covered in purple dye? That was triple dye. It is rarely used anymore.

Umbilical Cord Care Recommendations

So what is used now that we don’t use triple dye?

Although many parents are still tempted to use alcohol, the main advice is now to ‘do nothing’ and just let the cord fall off.

That is not a universal recommendation though.

“Ensuring optimal cord care at birth and during the first week of life, including use of chlorhexidine, especially in settings having poor hygiene, is a crucial strategy to prevent life-threatening sepsis and cord infections and avert preventable neonatal deaths.”

Chlorhexidine Working Group

Why the different recommendations?

Because, in some countries, 10 to 20% of live births are still complicated by umbilical cord infections.

But if antiseptics can help keep the umbilical cord stump free of infections, why not just use them?

It is thought that using these antiseptics when they aren’t necessary, like when a baby is born in a hospital under hygienic conditions in a “high-resource country,” then they may:

  • lead to the development of resistance and selection of “more virulent bacterial strains”
  • cause the cord to take longer to fall off – especially if you applied alcohol to the stump at each diaper change
  • waste money and resources

That’s why, when appropriate, it is now recommended that we practice dry cord care. And that’s great news, as it still seems like most parents don’t want to ever touch their baby’s umbilical cord stump!

Dry Cord Care

Give your baby sponge baths until the umbilical cord comes off to help it stay dry.
Give your baby sponge baths until the umbilical cord comes off to help it stay dry.

With dry cord care, you simply:

  • keep the umbilical cord stump clean and dry (sponge baths only until the cord comes off)
  • leave the umbilical cord stump exposed to air or loosely covered by a clean cloth (fold your baby’s diaper down, which will also help prevent the cord from getting soaked with urine)
  • clean the umbilical cord stump with soap and sterile water if it does get soiled
  • watch for signs and symptoms of omphalitis, including a foul smelling discharge, red skin around the umbilical cord, or if the cord or skin around it becomes tender

Keep in mind that dry cord care is likely not appropriate if your baby was born at home, was born in a “resource limited country” or community, or if you are putting any non-sterile products on the cord to ‘help’ it come off more quickly.

These natural products to avoid include clay, cord care powders, dried herbs, honey, and oils.

When should your baby’s cord come off? While the average time is about two weeks, it is usually not considered delayed unless it hasn’t fallen off by the time your baby is three or four weeks old.

What To Know About Umbilical Cord Care

Taking care of your baby’s umbilical cord stump is now easier than ever for most parents. Just keep it clean and dry and watch for signs of infection until it falls off.

More Information on Umbilical Cord Care

Circumcision

The American Academy of Pediatrics policy statement has shifted over the years.

They still don’t recommend that boys routinely get circumcised though.

Instead, the latest recommendation, which was published in a 2012 policy statement, states that:

…the benefits of circumcision are sufficient to justify access to this procedure for families choosing it and to warrant third-party payment for circumcision of male newborns.

While the health benefits of getting circumcised, including prevention of UTIs, penile cancer, and transmitting some STIs, outweigh the small risks of the procedure, the AAP states that parents still need to decide if circumcision is in the best interest of their male child, thinking about their own “religious, ethical, and cultural beliefs and practices.”

Don’t get your child circumcised because you think it will be too hard to clean his intact penis and don’t get your child circumcised because you think everyone else is doing it and he will have problems in the locker room. Those aren’t good reasons.

It is also important to keep in mind that if your child is circumcised, the AAP also states that babies should be given “adaquate analgesia,” (that’s pain control) including:

  • penile nerve block techniques
  • nonpharmacologic techniques, like positioning and sucrose pacifier, can be used as an adjunct to a penile nerve block

And of course, the AAP came out with a policy statement in 2010 against the “traditional custom of ritual cutting and alteration of the genitalia of female infants, children, and adolescents, referred to as female genital mutilation or female genital cutting (FGC).”

For more information: