The Vitamin K Shot

Vitamin K Deficiency Bleeding (VKDB) is spontaneous bleeding in the first six months of life. VKDB is unpredictable, often has no early symptoms, and is not associated with falls, trauma, injuries, etc. VKDB is rare, but when it does occur, it can have serious complications, including brain damage and death. If VKDB occurs, a Vitamin K shot can be given at that time to control bleeding (however, if bleeding occurs in the brain, it may be too late to stop brain damage). VKDB is classified as early, classic, and late. Symptoms of VKDB include easy or unexplained bruising, pale skin or gums, yellow eyes (past 3 weeks old), bloody stool, black stool (past 3 days old), vomiting blood, difficulty feeding, or bulging soft spots on baby’s head.

• Early VKDB occurs within the first 24 hours after birth. Early VKDB is rare and typically occurs in infants whose mothers took certain medications during pregnancy. The mortality rate is 20-50% if treatment is not administered promptly.

• Classic VKDB occurs when a baby is between 2 and 7 days old. This is the most common form of VKDB. It is typically mild, and the mortality rate is very low in developed countries.

• Late VKDB occurs between 2 weeks and 6 months old. Your baby’s chance of developing late VKDB is less than 0.0004% if they receive the Vitamin K shot and 0.0044% to .0072% if they do not receive the Vitamin K shot. The mortality rate of late VKDB is 20%. Approximately 40% of infants who survive will have long-term brain damage.

The overall risk of VKDB is very low (0 to 0.44% of babies who do not receive Vitamin K supplementation will develop classic VKDB). All infants are at some level of risk for VKDB. An infant may be at a higher risk of VKDB if the baby is circumcised, is exclusively breastfed, has gallbladder or liver problems, or the mother took certain medications during pregnancy (such as those to control seizures).

The Vitamin K shot is not “just a vitamin.” It is an injection and has risks. It’s not a vaccine, but it does contain ingredients besides Vitamin K that could be problematic. AquaMEPHYTON®, the most common Vitamin K shot used for infants in the United States, contains benzyl alcohol. The package insert states: “Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol preserved drugs, including AquaMEPHYTON… The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.” It also includes polyoxyethylated fatty acid derivative (which contains ethylene oxide, a suspected carcinogen), and glacial acetic acid (a chemical that is flammable and corrosive to metals and tissues; it is derived from ethanol, a neuroxin).

The preservative free version of the Vitamin K shot contains Polysorbate 80 (a chemical emulsifier and detergent that has the ability to open and pass through the blood brain barrier), propylene glycol, sodium acetate anhydrous, and glacial acetic acid.

According to the package insert, potential side effects of the Vitamin K shot (AquaMEPHYTON®) include pain, swelling, cyanosis (blue skin from low oxygen), hyperbilirubinemia (jaundice), eczema (can appear as late as a year after administration), fatal hypersensitivity reactions, and more. The “preservative-free” version of the Vitamin K shot (Phytonadione) has virtually identical side effects, including fatal hypersensitivity reactions.

The Vitamin K shot has a “boxed warning,” which is mandated by the FDA when a drug has “special problems, particularly ones that may lead to death or serious injury.” This boxed warning primarily applies to intravenous administration of Vitamin K in adults. Only one hypersensitivity reaction was observed in an infant who received an intramuscular injection of Vitamin K.

The Vitamin K shot reduces the risk of VKDB to nearly zero. In the event of bleeding, administration of the Vitamin K shot typically slows or stops bleeding within 20-30 minutes.

Risks of the Vitamin K shot include potential side effects, including pain, swelling, cyanosis, hyperbilirubinemia, eczema, hypersensitivity reactions, and death. Risks of declining the Vitamin K shot include a less than 1% risk of VKDB (late VKDB can cause brain damage and death). It is difficult to determine the exact risk profile of the Vitamin K shot because there is no standard reporting/tracking system for Vitamin K shot injuries. We were not able to find a source that publishes the rate of adverse reactions from the Vitamin K shot. Most literature states that injuries from the Vitamin K shot are rare (they also state that VKDB is rare).

The benefit of the Vitamin K shot is a reduced risk of VKDB (near zero). 0-0.4 babies per 100,000 who get the shot will get late VKDB. The benefits of declining the Vitamin K shot include no pain or discomfort for your baby and no risk of adverse reactions from the shot.

Yes, there are alternatives to the Vitamin K shot. You can give your baby oral Vitamin K, request that the contents of the Vitamin K shot be given orally, or take 2-4mg of daily oral Vitamin K if you are breastfeeding.

• Oral Vitamin K: Products like Dr. Green Life Natal K and Biotics Research Bio-K-Mulsion are available in the U.S. Oral Vitamin K “requires at least three doses to be effective (given at birth, 4 to 6 days, 4 to 6 weeks). Oral doses will not be absorbed well if the infant has an empty stomach, or if the baby spits up shortly after the dose is given.” -Evidence Based Birth. A Danish study that enrolled around half a million women who dosed 2 mg of oral Vitamin K at birth, followed by a weekly dose of 1 mg until 3 months of age, found no occurrences of VKDB.

• Give the contents of the Vitamin K shot orally: Former pediatrician Paul Thomas suggests this alternative in his book Vax Facts: What to Consider Before Vaccinating at All Ages & All Stages of Life. You can ask your healthcare provider to give the contents of the Vitamin K shot orally rather than as an injection. Thomas says, “They can dilute it in the hospital pharmacy and then give it by mouth.” This study found that “the administration of injectable vitamin K via oral route is effective and safe.” Note: This is an off-label use.

• Vitamin K supplementation for breastfeeding mothers: Breastfeeding mothers can take 2-4 mg of daily oral Vitamin K to increase Vitamin K levels in their breastmilk. Note: There is currently no research confirming this reduces the rate of actual VKDB in infants. Dietary sources of Vitamin K include brussels sprouts, leafy green vegetables (spinach, kale, broccoli), and fermented foods (such as sauerkraut).

According to Just The Inserts, “There is emerging research on the use of probiotics with the Lactobacillus rhamnosus GG strain that may help support vitamin K production in the gut for your baby.”

Remember, it’s up to you as a parent to decide if your baby “needs” Vitamin K in any form. You have the right to accept, delay, or decline any medical procedure.

It’s up to you as a parent to decide if your baby “needs” Vitamin K at all. Having an uncomplicated birth (vaginal birth without intervention or other trauma) does not mean your baby is not at risk for VKDB. VKDB is not related to trauma, injuries, falls, etc. All babies are at a low risk for VKDB (even a small percentage of babies who get the Vitamin K shot get late VKDB). A traumatic birth might increase a baby’s risk for VKDB, just as circumcision increases a baby’s risk.

There are many hypotheses about why Vitamin K levels are low at birth. Some speculate that there is an evolutionary reason or perhaps an unknown mechanism that keeps toxins from reaching the baby and blocks Vitamin K transfer. It is intriguing that in the Bible, God commands the Israelites to circumcise their baby boys when they are eight days old (not before). Most cases of VKDB occur between two and seven days old.

Interestingly, some infant vaccines recommended by the CDC list thrombocytopenia as a potential side effect. Thrombocytopenia is a condition where blood is less able to clot and may cause abnormal bleeding. Thrombocytopenia is listed as an adverse reaction to the Hep B, RSV, rotavirus, and DTaP vaccines, all of which are administered within the first six months of life, when babies are most at risk for VKDB.

Most hospitals have a standing order to administer the Vitamin K shot. If you don’t want your baby to receive it, you must make that very clear. In his book Vax Facts: What to Consider Before Vaccinating at All Ages & All Stages of Life, former pediatrician Paul Thomas recommends the following: “Tell every nurse and doctor you see that you don’t want it, hand them a written document stating what you don’t want it, put a sign up in the room, and… never let your baby out of your sight.”