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All of the infants were exclusively breastfed, and they all had critically low levels of Vitamin K in their blood. Concerned by this outbreak, the hospital asked the Centers for Disease Control (CDC) to look into the situation. Note: This article includes photos and a story of an infant who experienced late Vitamin K deficiency bleeding. Vitamin K1 from plants makes up about 90% of our overall Vitamin K levels, while Vitamin K2 from bacteria makes up only about 10% of our overall Vitamin K intake. Vitamin K is necessary for our bodies to activate certain molecules (also known as clotting factors) that help the blood to clot.
For the most part, our bodies can continue to clot appropriately with low Vitamin K levels.
Secondary VKDB means that the baby has an underlying disorder such as gallbladder disease, cystic fibrosis, or medication side effects. Vitamin K deficiency bleeding can follow one of three patterns: early, classical, and late.
In 1930, a Danish biochemist found that Vitamin K deficiency was the cause of unexpected bleeding in baby chicks (Lippi and Franchini 2011). In 1944, a definitive Swedish study was published including more than 13,000 infants who were given 0.5 mg of Vitamin K (either oral or injection) on the first day of life.
In 1961, after nearly 2 decades of research had been published, the American Academy of Pediatrics recommended giving Vitamin K shots after birth.
By 1999, the name HDN was changed to Vitamin K deficiency bleeding (VKDB) to indicate that that this condition is caused solely by Vitamin K deficiency. Table 1: Newborn deaths due to bleeding before and after Vitamin K was introduced on September 1st, 1940 (Lehmann, 1944).
Late bleeding (after the first week of life) is the most dangerous kind of VKDB (Shearer 2009).
When infants receive the Vitamin K shot at birth, anywhere from 0 to 0.62 infants per 100,000 have VKDB.
In low-income countries, many babies with late VKDB may die before reaching the hospital, and because their diagnoses and deaths are undocumented, these cases would not be counted in any of the VKDB statistics. One of the most dangerous things about VKDB is that you may not recognize it until it is too late. Other treatments that have been used in infants with late VKDB include blood and plasma transfusions, brain surgery to remove the accumulated blood, and giving anti-seizure medicines (Personal communication, Dr.
Depending on the country in which the Vitamin K is administered, there are 1 to 2 mg of Vitamin K1 in the injection. 10 mg of Polysorbate 80, which helps Vitamin K1 (a fat-soluble Vitamin) dissolve in liquid for the injection.
10.4 mg of Propylene glycol, which helps absorb extra water and maintain moisture in certain medicines. As far as allergic reactions to the Vitamin K shot, almost all of the cases in history occurred with the intravenous (IV) form, something that is never used in the newborn period unless an infant comes in with vitamin K deficiency bleeding. Side effects from vitamin K injection given at birth are incredibly rare and if they are seen, they end up being case reports due to rarity.
In 2014, researchers published a case report about an infant who had a severe allergic reaction to the shot and went into shock.
Any injection can lead to site irritation and redness, but this is rare and it almost never leads to any intervention.
Infants who are circumcised and whose parents decline Vitamin K may be more likely to experience bleeding at the circumcision site, especially if the baby is breastfed. Olive and her mother Stefani, four days after Olive had brain surgery to remove excess blood due to the Vitamin K deficiency bleed.
There is no good evidence that giving the mother extra Vitamin K during pregnancy can prevent VKDB in infants. Some people have suggested that an alternative strategy for boosting the Vitamin K intake of breast fed babies is for the mother to take a daily supplement herself after birth.
In the second part of the study, 22 mothers were randomly assigned to take either 5 mg of Vitamin K daily with a meal, or placebo.
In a large Japanese study with more than 3,000 mother-infant pairs, researchers tested a maternal dose of 15 mg of Vitamin K2 by mouth once a day. The shot has a delayed release effect that protects against both classical and late bleeding. In contrast, the typical 3-dose regimen of oral Vitamin K1 lowers the chance of VKDB but does not eliminate it entirely. One reason that other countries may use the oral version of Vitamin K is because mothers and infants usually receive home visits from nurses. The two main risk factors for VKDB are exclusive breastfeeding and not receiving the Vitamin K shot. It is important to note that Vitamin K deficiency bleeding can happen to any infant, whether they are pre-term and full-term, male or female, trauma or no trauma.
In 1944, researchers who introduced the Vitamin K shot found that babies may be more likely to have brain bleeds or intestinal bleeds shortly after birth if they had a traumatic birth (Lehmann, 1944). In fact, I could find no recent evidence supporting the theory that infants born with instrumental help, or by Cesarean, are at higher risk for Vitamin K deficiency bleeding. In one of the largest studies on this topic, Thai researchers followed women during pregnancy and after birth and examined risk factors for Vitamin K deficiency. As far as insufficient breastfeeding in the first hours of life goes, there is a link between insufficient amounts of breast milk in the first few days of life and classical VKDB. Also, this theory does not explain late VKDB, which happens a week or more after birth, and is the more dangerous kind of bleeding. As mentioned earlier, the timing of cord clamping probably does not have any effect on VKDB, since Vitamin K is usually undetectable in cord blood. In summary, the most important risk factors for VKDB are exclusive breastfeeding and not getting the Vitamin K shot. In European countries, when they went from no Vitamin K1 to giving Vitamin K1 shots, researchers estimate that this probably prevented anywhere from 4 to 7 cases of late VKDB per 100,000 infants (Shearer, 2009).
In 1990, a British newspaper reported that researchers had found a link between Vitamin K injections and childhood leukemia (Golding, Greenwood et al. Over the next two decades, there were a total of 12 studies examining the link between injectable Vitamin K and leukemia. In 2002, researchers combined data from six major studies that looked at the potential relationship between Vitamin K and childhood cancer.
In 2003, researchers in Great Britain conducted the highest-quality study to date to determine whether there was a relationship between Vitamin K and childhood cancer. After twenty-four years of studying the possibility of a link between Vitamin K and childhood cancer, researchers have now come to the conclusion that there is no evidence supporting a relationship between Vitamin K and leukemia or other childhood cancers (Shearer, 2009). Please do not make any health decisions for yourself or your family based on information you read on the internet (including this article) without talking with your healthcare provider first. Some countries such as the United Kingdom, Germany, and the Netherlands have surveillance programs to monitor the effectiveness.
Most of the studies in the Cochrane review looked only at infants who were exclusively breastfed. In two very important studies that took place in the 1960s, researchers compared injectable Vitamin K to no Vitamin K for the prevention of classic VKDB. In the studies that compared the Vitamin K shot to a single dose of oral Vitamin K, some researchers found no difference in lab results. Table 2 below shows the rates of late VKDB in multiple countries over different time periods. Out of these 32 cases, 2 infants did not receive any Vitamin K at all, 6 infants did not complete the entire 3-dose regimen, and 22 received all 3 doses of oral Vitamin K. In other words, although giving 3 doses of oral Vitamin K1 is better than nothing, it does not work 100% of the time, and infants who receive the oral regimen are still at risk for late VKDB.
If parents choose the oral version of Vitamin K, it is very important that they give their infant all three doses. On the other hand, almost every research study has shown that giving the Vitamin K shot works nearly 100% of the time at protecting infants from late VKDB.
Based on one observational study, the best oral regimen seems to be a weekly oral Vitamin K regimen. The main concern with using oral Vitamin K is that it may not work for infants with undiagnosed gallbladder problems (Ijland, Pereira et al. Babies with gallbladder problems have trouble absorbing fat and fat-soluble vitamins like Vitamin K, so they are at higher risk for late VKDB. Both Denmark and the Netherlands have national registries where they track these rare infants with gallbladder problems. In the Netherlands, all infants had 1 mg of oral Vitamin K after birth, and breastfed infants had 25 micrograms (mcg) daily by mouth until the end of the 13th week. Between 1994-2000, all infants had 2 mg oral Vitamin K after birth, then 1 mg of oral Vitamin K weekly, as long as at least 50% of their daily feedings were made of breast milk.

The risk of a breastfed baby with gallbladder problems having late VKDB was 8 times higher in the Dutch infants compared to infants who were part of both Danish regimens. The results showed that the Danish weekly regimen was more effective than the Dutch daily regimen, probably because the overall weekly dose (1 mg) was much higher in Denmark than the overall weekly dose given in the Netherlands (0.18 mg). After this study came out, the Netherlands increased their daily dose to 150 micrograms per day, so that it would be closer to the Danish overall total of 1 mg total per week (de Winter et al.
If the weekly or daily oral Vitamin K regimen is used, it is important to remember that when this fat-soluble vitamin is given on an empty stomach, it may not be absorbed as well as Vitamin K1 that is mixed into formula (Cornelissen, Kollee et al.
In the Netherlands, the current practice recommendation consists of giving 1 mg Vitamin K orally directly after birth and a daily dose of 150 mcg from day 8 through 13 weeks of life (de Winter et al, 2011).
In New Zealand, the guidelines state that infants should receive 1 mg of Vitamin K as a single intramuscular shot at birth. In the United Kingdom, guidelines state that all parents should be offered Vitamin K for their infants.
Giving a breastfed infant a Vitamin K1 shot virtually eliminates the chance of life-threatening Vitamin K deficiency bleeding. A regimen of three doses of oral Vitamin K1 at birth, 1 week, and 1 month reduces the risk of bleeding. The Danish regimen of 2 mg oral Vitamin K after birth and then 1 mg orally each week seems to protect infants at higher risk who have undiagnosed gallbladder disease. Recently, there have been many myths, misconceptions, and misinformation floating around the internet and social media about Vitamin K. I would like to acknowledge Mandi Hardy Hillman, PhD, LPC, CD(DONA), ICCE, for her invaluable assistance with the literature search. I would like to acknowledge my expert reviewers: Mark Sloan, MD, Pediatrician and Assistant Clinical Professor at the University of California, San Francisco, and Robert F. I would also like to thank Cristen Pascucci and Sharon Muza CD(DONA), BDT(DONA), LCCE, FACCE for their medical editing assistance.
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I shared my personal thoughts on the evidence for the Vitamin K shot in this exclusive interview with Lamaze’s research blog, Science and Sensibility.
The infants ranged in age from seven weeks to five months old; three were male and three were female. Most importantly, what these infants had in common was that all of their parents had declined Vitamin K shots at birth. Researchers from the CDC examined Tennessee hospital records and found that between the years 2007 and 2012, there had been zero cases of Vitamin K deficiency bleeding out of more than 490,000 births.
Only one of the families was aware that life-threatening bleeding was a possibility if they declined the injection (Warren, Miller et al.
Her Vitamin K shot was unintentionally omitted at birth, and as a result of Vitamin K deficiency, she had a severe brain bleed at 2 months old. The blood clotting factors are there in normal numbers at birth, but not activated fully due to low levels of Vitamin K.
Early VKDB is usually seen in babies born to mothers who took medicines that interfere with Vitamin K. The researcher found that infants who received Vitamin K experienced a 5-fold reduction in the risk of bleeding to death during the first week of life. In an 18 year period in the United Kingdom, only two babies who received the shot had late VKDB brain bleeds, out of 64 million births (Busfield et al. On the other hand, it is more common in some Asian countries, such as Japan, Vietnam, and Thailand.
When an infant with VKDB receives a shot of Vitamin K1, this will usually slow or stop the bleeding within 20-30 minutes (Shearer 2009). Their levels are lowest at days 2-3 and do not reach adult levels until about 6 months of age. Colostrum has about 2 micrograms of Vitamin K per Liter, while mature milk has 1 microgram per Liter (von Kries et al, 1987).
When studies looked closely at infants who develop late VKDB, they found that mothers of these babies had normal levels of Vitamin K in their milk supply. This dose is what was tested in the original studies on Vitamin K, starting in the 1960s and continuing into the 21st century. Polysorbate 80 is made from natural sorbitol and plant-based oleic acid, is used in a wide variety of foods, medicines, and vitamin supplements, and is included in the Handbook of Green Chemicals. Proplyene glycol is used in many medications (oral, topical, and injections) because it is a very good at helping medications absorb into liquid.
This dose, which was 30 times higher than the one used in the Vitamin K shot, led to seizures in the infant.
Before the 1960s (mostly in the 1950s) there were some reports of severe jaundice and anemia, as the dose was not determined and the formulation was quite different. The infant survived, but researchers were unable to figure out why the newborn had this type of reaction. Injections can also cause pain, which can be minimized by nursing the baby during the shot. In a large clinical trial in the 1960s, researchers found that administering Vitamin K at birth can decrease the risk of bleeding during a circumcision.
After applying pressure for 90 minutes, with no decrease or cessation in the bleeding, they discovered that the baby had not received a Vitamin K injection.
In the largest known study looking at diets and Vitamin K deficiency, researchers followed 683 mothers before pregnancy and after giving birth. They found that this dose resulted in low infant Vitamin K levels in only 0.11% of the treatment group. Well, so far, the studies that have been done looked at babies in which both the babies AND their mothers received supplements. Also, infants with underlying (and sometimes undetected) gallbladder or liver disorders may not be able to absorb the oral Vitamin K when it is given in a 3-dose regimen. For example, oral Vitamin K is offered to almost all parents in the United Kingdom who refuse the Vitamin K shot, but that is because they have a licensed oral version available.
Maybe there is an unknown beneficial mechanism that is preventing some kind of environmental toxin from reaching the baby, and this mechanism also has the side effect of keeping Vitamin K from reaching baby in sufficient quantities through the placenta and breastmilk. The point is that they are born with low levels of Vitamin K, and that some babies will die from Vitamin K deficiency bleeding if they do not receive supplemental Vitamin K at the beginning of life. However, this 60-year old finding has evolved into a myth in which people believe that the only babies who are at risk are those who had traumatic births (Cesarean section, forceps, or vacuum delivery). And it is theoretically possible that traumatic experiences at birth would make a baby more likely to bleed during the first week of life if they have low Vitamin K levels. In Asian countries, where rates of VKDB are high, if you administer the Vitamin K1 shot to 100,000 infants, researchers estimate this would prevent 11 deaths, 340 years of lost life from the children who would have died, and 53 cases of life-long disability (Danielsson, Hoa et al.
After carefully reviewing the evidence, they issued a statement saying that there was not enough evidence to support a link between Vitamin K and childhood cancer. In this study, there were 2,530 children with cancer (half of whom had leukemia) and 4,487 children without cancer.
In fact, some of the children in Tennessee who developed life-threatening VKDB did not receive Vitamin K because their parents thought that the shot could cause leukemia.
The same article, as well as others, lists the side effects of intravenous Vitamin K and state that your child is at risk for these side effects if they receive the Vitamin K shot. Because late VKDB is so rare, the researchers could only look at the effects of Vitamin K on classical VKDB and laboratory results (Puckett and Offringa 2000). The researchers found that Vitamin K led to a 27% decrease in the risk of bleeding between one and seven days, and an 82% decrease in the risk of bleeding after a circumcision. However, when researchers looked specifically at Vitamin K levels, they found that the Vitamin K shot resulted in significantly higher levels of Vitamin K at one week and one month when compared to the single oral dose. For example, you could compare rates of VKDB during time periods when countries used nothing, when they used oral Vitamin K, and when the Vitamin K shot became standard care. As you can see, the Vitamin K shot (IM Vitamin K1) basically eliminated all cases of late VKDB.
However, even if all three doses are completed, the infant will still be at risk for bleeding. There have been no randomized trials that compare weekly or daily oral Vitamin K to the Vitamin K shot. Often the first sign of a gallbladder problem is bleeding in the brain or stomach from Vitamin K deficiency (Van Hasselt et al. This gave researchers a unique chance to look at late VKDB in breastfed infants with gallbladder problems who received either daily or weekly oral Vitamin K, or the shot (Van Hasselt et al. Five out of these 23 infants had a Vitamin K deficiency, and two of the five had late VKDB. The main reason that they stopped using the oral Vitamin K was because it was no longer available on the market. The AAP does not recommend oral Vitamin K, because some infants may have trouble absorbing it and there is no FDA-approved version in the U.S.

If parents do not consent to the shot but do consent to oral Vitamin K, then 2 mg of Vitamin K should be given by mouth soon after birth, once at 3-7 days, and again at 6 weeks. The only known adverse effects of the shot are pain, bleeding, and bruising at the site of the injection. Although this 3-dose oral Vitamin K1 regimen is better than nothing, it is not 100% effective. It is important that parents look at the facts so that their consent or refusal is informed.
You will receive 4 videos sent to your email inbox over the next week, along with a FREE, one-page, printable handout on Vitamin K that you can share with clients, health care providers, and friends! Sidonio, Jr., MD, Pediatric Hematologist-Oncologist and Assistant Professor at Vanderbilt University. Three of the infants were born in hospitals, two were born at home, one was born in a birth center.
They randomly sampled records from babies born at three Nashville hospitals and found that 96.6% of infants received Vitamin K injections.
These medicines may include warfarin (Coumadin), seizure medications, and tuberculosis medications. Common bleeding sites include the gastrointestinal system, umbilical cord site, skin, nose, and circumcision site. It was estimated that for every 100,000 full-term infants who were born, Vitamin K would save the lives of 160 infants per year (Lehmann 1944). This type of VKDB is usually mild and involves bleeding at the umbilical cord site or circumcision site. Mortality rates from classical VKDB are probably higher in developing countries such as Ethiopia because of scarce medical resources and a delay between when babies start to bleed and when they receive treatment (Lippi & Franchini, 2011). However, if bleeding happens in the brain, the infant may already have brain damage by the time the shot is given.
Vitamin K1 is poorly retained in the body, and the Vitamin K1 that is stored is primarily in the liver, not in the bloodstream. After these mothers were given Vitamin K, the researchers were able to detect Vitamin K1 in the cord blood in 4 out of 6 infants, but the levels were still very low. Any cases about severe side effects from propylene glycol are from decades ago, and were related to very high doses. During this time they were using a water soluble version of the vitamin K shot and following these cases, they changed to the fat soluble version that is used today.
They noted that this was the first case ever reported in which an infant went into an allergic shock from Vitamin K, when the shot has been given all over the world for many decades (Koklu et al. In this study, infants who were born on odd-numbered days received a Vitamin K shot at 24 hours of age, while infants who were born on even-numbered days did not. He received a 2-mg injection and the bleeding stopped within 30 minutes (Plank, Steinmetz et al. In one small study with only 6 mothers, a 2.5 mg oral dose twice a day (5 mg total per day, or one hundred times the amount that would otherwise need to be given to the baby each day) was enough to raise the vitamin content of the milk to acceptable levels (Bolisetty, Gupta et al. In the first phase, mothers were randomly assigned to take 2.5 mg or 5 mg of Vitamin K daily by mouth. When oral Vitamin K is used it requires at least 3 doses (birth, 1 week, and 6 weeks), and the breakthrough cases of Vitamin K deficiency bleeding are often related to missing the final dose (Busfield, Samuel et al.
Because of this, doses of Vitamin K are typically given to all newborns or to those whose mothers intend to exclusively breastfeed (Shearer, 2009). I have seen this myth perpetuated in many blog articles and on social media, without any supporting evidence or references to back up these claims. The researchers found no difference in the percentage of infants with Vitamin K deficiency between the low-risk and high-risk infants (Chuansumrit et al, 2013).
But research (see above) has not supported the theory that traumatic deliveries are directly related to Vitamin K deficiencies. They were all healthy, exclusively breast fed infants born during spontaneous vaginal births at term. When the study was published, there was a massive switch in Great Britain from the Vitamin K shot to oral Vitamin K. The researchers found no association between injectable Vitamin K and any type of childhood cancer (Roman, Fear et al. The researchers found that 39% of children with cancer had received the injectable Vitamin K, while 42% of children without cancer had received the Vitamin K.
This is not surprising, given that rumors, myths, and non-evidence based information about Vitamin K run rampant on the internet. These authors do not even understand the difference between intravenous and intramuscular injections.
Instead, researchers looked at changes in laboratory results that indicate Vitamin K deficiency.
The use of three doses of oral Vitamin K1 (at birth, one week, and one month of age) lowered the risk of late VKDB but did not eliminate it entirely. Almost all (29 out of 30) had a severe deficiency, 83% had bleeding (late VKDB), and 43% had brain bleeds. There was one case of late VKDB after the weekly oral Vitamin K, and one case of late VKDB after the shot.
Because it is sold as a supplement without FDA approval, this medication is not required to have the stated amount of vitamin K. Parents should be informed that bleeding can still occur with the oral Vitamin, even if the parents comply with the oral regimen. If the parents do not consent to the Vitamin K shot, they can be offered the oral Vitamin K, but they should be informed that this method requires multiple doses.
Out of many millions of injections, there has only been one report of an allergic reaction in recent history. It is important for parents to administer all 3 doses in order for this regimen to help lower the risk of late Vitamin K deficiency bleeding. Right now, parents who have been declining Vitamin K may not have all the information, or they may have been given inaccurate information. Improving the vitamin K status of breastfeeding infants with maternal vitamin K supplements.
Although the six infants survived, two required emergency brain surgery to save their lives, one has severe brain damage (a stroke with right-sided paralysis and severe cognitive delays), and two have mild to moderate brain injuries (Schulte et al, 2014).
In contrast, only 72% of infants born in local freestanding birth centers received Vitamin K (Warren, Miller et al. Although Vitamin K deficiency bleeding is rare, it is real and it can happen to real infants. Townsend was the first person to figure out that there was a connection between poor or insufficient breastfeeding and bleeding in newborns (Shearer 2009). And it can take even longer for health care professionals to figure out what is wrong (Schulte et al.
So although delayed cord clamping increases iron levels, it is highly unlikely that this would help raise Vitamin K levels enough to prevent VKDB (Shearer 2009; Olson 2000).
This kind of delayed-release explains why the shot protects babies from both classic AND late Vitamin K deficiency bleeding (Loughnan and McDougall 1996) . But the Vitamin K had a dramatic effect on breast milk levels of Vitamin K, increasing it 70 times compared to placebo.
It appears that when the mother takes 5 mg of Vitamin K per day, that this is very effective in raising levels of Vitamin K in breast milk, and probably raises Vitamin K levels in the baby.
However, this condition is extremely rare (1 out of every 60,000 babies), and it has no relationship to adult gallbladder or liver disease. There was also a huge rush to study Vitamin K1 injections to find out whether there really was a link between the injection and cancer (Shearer 2009). And yet parents all over the world are reading information from these websites and making important health decisions based on misleading and inaccurate claims. So if parents give their breast fed infants oral Vitamin K, it is important that they give it with a feeding, and make sure that it is not spit up. The amount could vary widely from vial to vial, and K-Quinone is not regulated or certified by a third party. Both the babies and their mothers had not been taking any antibiotics, they had not been sick, the mothers were not on restrictive diets, and the babies had no head trauma. As always, please read the Evidence Based Birth disclaimer and do not make any health care decisions without talking with your care provider first.
Some infants may also be at higher risk if they have undetected gallbladder disease, cystic fibrosis, chronic diarrhea, and antibiotic use. But so far, researchers have not tested the effects of maternal Vitamin intake on rates of actual Vitamin K deficiency bleeding in infants.

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