Vitamin K given to infants-what you may not know…..
PHYTONDIONE VITAMIN K INJECTION
Aqueous solution containing fat-soluble vitamin K
An aqueous solution containing fat-soluble vitamin K is prepared by adding vegetable oil(s), gycerol fatty acid ester(s) or sorbitan fatty acid ester(s) in an amount of 0.004 to 5% by weight, based on the whole aqueous solution, to an aqueous solution containing menatetrenone (vitamin K2) or phytonadione (vitamin K1) and hydrogenated lecithin.
MULTTVITAMIN PREPARATION AND METHOD
US Pat. 2980588 – Filed Jul 18, 1957 – Les Labora
120; 100 mg. vitamin BI, 100 mg. of acetylated vitamin K … This is brought up
to exactly 100 cc. by the addition of gelled peanut oil. …
STABILIZATION OF FAT-SOLUBLE VITAMIN
US Pat. 2973266 – Filed Feb 5, 1958 –
… vitamin E in an edible oil solvent, and vitamin K in an edible … Limpid
peanut oil 94 Hydrogenated cottonseed oil Hydrogenated soybean oil 35 43 70 68
Aqueous solution containing fat-soluble vitamin K
US Pat. 5021570 – Filed Jul 7, 1989 – Eisai Co., Ltd.
… ing fat-soluble vitamin K, which solution contains speci- The term “residual
… peanut and corn oils, thin is used together with an adjuvant (cf. …
Oxidative stabilization of omega-3 fatty acids in low linoleic acid …
US Pat. 7344747 – Filed Apr 29, 2004 – GFA Brands, Inc.
19 20 Percentage Flax Oil Added to Peanut Butter 10 The blend of 8 percent flax
oil … and vitamin K, and a carotenoid that is a carotene or a xanthophyll. …
METHOD OF MAKING SAME
US Pat. 2937091 – Filed Jul 2, 1953 –
… vitamin E in an 10 15 oe- 40 70 edible oil solvent, and vitamin K in an
edible .oil vehicle or in crystalline form. … Hydrogenated peanut oil 45 55.
Vitamin K –Is this really safe and necessary? Bronwyn Hancock October 2003
…The vitamin K injections administered by hospitals and manufactured by Merck and Roche and Abbott contain benzyl alcohol as a preservative. … Roche’s vitamin K product KONAKION contains ingredients such as phenol (carbolic acid-a poisonous substance distilled from coal tar), propylene glycol (derived from petroleum and used as an antifreeze and in hydraulic brake fluid) and acetic acid (an astringent antimicrobial agent that may drastically reduce the amount of natural vitamin K that would have otherwise been produced in the digestive tract). As reported in the PDR and as published in the IM vitamin K packet inserts for Merck, Roche and Abbott, “Studies of carcinogenicity, mutagenesis or impairment of fertility have not been conducted with Vitamin K1 Injection (Phytonadione Injection, USP).” · The Vitamin K injection can be in a base of polyethoxylated castor oil. · Vitamin K injections also contain hydrochloric acid and lecithin. Effects of Vitamin K administration · The manufacturers warn on the product insert: “Severe reactions, including fatalities, have occurred during and immediately after intravenous injection of phytonadione even when precautions have been taken to dilute the vitamin and avoid rapid infusion..” …· According to the product insert, adverse reactions include hemolysis (or hemolysis – American spelling) (meaning breakdown of red blood cells), hemolytic anemia (a disorder characterized by chronic premature destruction of red blood cells), hyperbilirubinemia (too much bilirubin in blood) and jaundice (yellow skin and eyes resulting from hyperbilirubinemia), and allergic reactions include face flushing, gastrointestinal upset, rash, redness, pain or swelling at injection site and itching skin. ...
As early as April 17, 1977, an article in one of the world’s most esteemed medical journals, the Lancet, discredited the policy of routine vitamin K injections. “We conclude that healthy babies, contrary to current beliefs, are not likely to have a vitamin K deficiency.. the administration of vitamin K is not supported by our findings..” Van Doorm et al stated in the Lancet article. VKR cited 21 peer-reviewed reports that had been published in prominent medical journals. All of them concur that policies that mandate the universal injection of newborn babies are not based on sound science. There has been much peer-reviewed evidence generated which questions the efficacy of routine vitamin K injections as sound public health policy. ·
From the July 1999 Idaho Observer: National standard mandates newborn vitamin K injection
Ignorance becomes tacit consent for the questionable neonatal procedure by Don Harkins In cooperation with a “national standard,” most, if not all states have mandated that U.S. hospitals routinely administer to all newborns a synthetic, fat-soluble vitamin K injection (generic name phytonadione) that exceeds an infant’s recommended daily dietary intake of the vitamin by 100 times…
Five post partem nurses from hospitals in Idaho, Washington and Oregon stated that they “routinely administer vitamin K injections to newborns,” as if all of them were reading from the same script. According to a seasoned Sacred Heart Medical Center (Spokane, WA) Birthplace nurse named Terri, “Routine vitamin K injections are in cooperation with the federal standard.” She also said that Washington hospitals are mandated by state code to provide the injections to all newborns. Terri acknowledged that parents who wish to refuse the shot must present the refusal to the hospital in writing before the baby is born.
…Babies who have been identified as being at risk for vitamin K deficiency include those born to mothers who took drugs or antibiotics during pregnancy, premature babies and babies who are born cesarean. Mothers who had maternity diets low in high vitamin K foods or had diets that were low in fat have also been identified as being more likely to bear vitamin K deficient babies.
…Commonsensically, VKR poses the question, “…how could God (or nature) have erred so badly as to give all newborn babies only an infinitesimal fraction of their required vitamin K? Surely the human race could not have survived to this point if all newborns were born with this deficiency and none being administered at birth until very recently.”
…The body less readily utilizes synthetic vitamins and minerals. The vitamin K administered by hospitals to newborns is the synthetic phytonadione.
…The purpose of this article is to alert expectant parents that their ignorance of federally-suggested, state mandated hospital policy is enough assent to authorize health care professionals to administer what may be a lethal or damaging overdose of a synthetic substance that comes with the following warning from the manufacturers: “Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of phytonadione even when precautions have been taken to dilute the vitamin and avoid rapid infusion…” Please pass the preceeding information onto anybody you know who is expecting a baby. Afterall, we have the right to know what substances are being injected into our babies within the first hour of their lives. If we feel that a substance may be injurious to our baby, we have the right to refuse it.
Phytonadione Therapy in a Multiple-Drug Overdose: Adverse Effects of Vitamin K Severe adverse effects are associated with intravenous phytonadione, such as cardiac irregularities, chest pain, cyanosis, decreased level of consciousness, circulatory collapse, rapid weak pulse, hypotension, and cardiac or respiratory arrest. It is not known if these reactions are due to the drug or the injection vehicle. Earlier reactions to vitamin K were thought to be due to polyoxyethylated castor oil (cremophor).[29-32] The literature contains numerous cases of anaphylactic reactions[29, 30, 32-38] as well as fatalities[34, 35] with parenteral phytonadione. The recommended infusion rate of vitamin K is no faster than 1 mg/minute; however, anaphylactic reactions have occurred with slower infusion rates[33, 37] as well as with repeated exposure to intravenous vitamin K.[30, 33, 34, 37] Dermatologic reactions were reported after intravenous, subcutaneous, and intramuscular administration of vitamin K. Two distinct types of local cutaneous reactions have been described. The more common one is a pruritic, erythematous, eczematoid, indurated plaque measuring 6-20 cm around the site of injection.[39-52] The acute reaction may resolve in 2-4 weeks with treatment with high-potency corticosteroids (e.g., fluocinonide, betamethasone dipropionate). The second type appears as a scleroderma or morphea-like reaction.[53-56] The onset can be weeks to months, and the skin change may last for years. Dose does not appear to bear a relationship to the onset of these reactions. Liver disease was associated with most reports of vitamin K cutaneous hypersensitivity,[39, 41] but the pathophysiology is unclear.
Anaphylactoid Reactions to Vitamin K
Louis D. Fiore1, Michael A. Scola1, Colleen E. Cantillon1 and Mary T. Brophy1 (1) Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), VA Boston Healthcare System, 150 South Huntington Avenue, Boston, MA, 02130
Anaphylactoid reactions in patients receiving intravenously administered vitamin K have been reported in the literature. To summarize the known data on anaphylactoid reactions from administration of vitamin K, we reviewed all published and unpublished reports of this adverse reaction. Published reports were obtained through medline (1966–1999) and EMBASE (1971–1999) searches of the English language literature and review of references from identified case reports. Unpublished reports were obtained using the Spontaneous Reporting System Adverse Reaction database of the United States Food and Drug Administration (FDA) between August 1968 and September 1997. All adverse drug reactions to vitamin K were categorized by route of drug administration, dose and standard adverse reaction code. In the FDA reports, we defined anaphylactoid reactions as any adverse drug reaction coded as either anaphylaxis, allergic reaction, apnea, dyspnea, death, heart arrest, hypotension, shock or vasodilatation. Additionally, all fatal and life-threatening FDA reported reactions were reviewed to determine if they could represent an anaphylactoid reaction missed by the above definition. The literature review uncovered a total of 23 cases (3 fatal) of anaphylactoid reactions from intravenous vitamin K. The FDA database contained a total of 2236 adverse drug reactions reported in 1019 patients receiving vitamin K by all routes of administration. Of the 192 patients with reactions reported for intravenous vitamin K, 132 patients (69%%) had a reaction defined as anaphylactoid, with 24 fatalities (18%%) attributed to the vitamin K reaction. There were 21 patients with anaphylactoid reactions and 4 fatalities reported with doses of intravenous vitamin K of less than 5[emsp4 ]mgs. For the 217 patients with reactions reported due to vitamin K via a non-intravenous route of administration, 38 patients had reactions meeting the definition of anaphylactoid (18%%), with 1 fatality (3%%) attributed to the drug. The absolute risk of an anaphylactoid reaction to intravenous vitamin K cannot be determined by this study, but the relatively small number of documented cases despite widespread use of this drug suggest that the reaction is rare. Anaphylactic reactions and case fatality reports were found even when intravenous vitamin K was given at low doses by slow dilute infusion. The pathogenesis of this reaction is unknown and may be multifactorial with etiologies including vasodilation induced by the solubilizing vehicle or immune-mediated processes. We conclude that use of intravenous vitamin K should be limited to patients with serious hemorrhage due to a coagulopathy that is secondary to a relative or absolute deficiency of vitamin K.
Neurosurgeon, Dr. Russell Blaylock, shares the science on how particular vaccine ingredients lead to convulsions, seizures, ADD, ADHD, autism…etc.
Vitamin K and Hepatitis B are mandated in most states to be given to newborns before they go home with mom. This has been proven to be a dangerous procedure at best. Potentially lethal.
The marketed purpose of the Vitamin K injection is that newborns have very little to begin with. Vitamin K is essential for the ability of blood clotting should any injury occur. Another marketed purpose is the prevention of hemorrhagic diseases of the newborn (HDN). HDN is a bleeding disorder associated with low levels of vitamin K in newborn babies. It was first defined in 1894 by Townsend as spontaneous external or internal bleeding occurring in newborn infants. Diagnosis was based solely on the opinion of the attendant medical personnel because there was no criteria in determining the cause of hemorrhaging. Townsend did not label hemophilia as a cause of HDN. The vaccine is also marketed to be essential prior to surgery. Thus, supposedly prevents excessive bleeding. Vitamin K is naturally stored and metabolized by the liver. The cell division that rapidly continues after birth depends on precise amounts of vitamin K to proceed at the proper rate. Introduction of levels that are 20,000 times the newborn level, the amount usually injected, can have devastating consequences. Nursing naturally raises the infant’s vitamin K levels very gradually after birth so that no disregulation occurs that would encourage leukemia development. This is the way the Creator designed it to be. The clotting system of the healthy newborn is well planned, and healthy breastfed infants do not suffer bleeding complications, even without any supplementation. While nursing infants demonstrate lower blood levels of vitamin K than the “recommended” amount, they show no signs of vitamin K deficiency. This can only lead to the question of how and where the “recommended” amount was brought about….
The only known reported cases of vitamin K toxicity result from having used the synthetic inoculated form. Vitam K inoculations can cause possibly fatal allergic reactions even during injection. The risks of injecting vitamin K into a newborn baby are nerve or muscle damage because it is injected deeply into the muscle, not subcutaneously under the skin. wpe49F.jpg (16360 bytes)
On the product insert, some reactions are listed:
You may notice pain, swelling and tenderness at the injection site for a few days. Notify your doctor if you experience any of the following while taking this drug: chest pain, flushing, strange movements, rapid pulse, tightness of the chest, cramps. In the unlikely event you have an allergic reaction to this drug, seek medical attention immediately. nerve and muscle damage as the Vitamin K injection must be given deeply into the muscle. However, should a newborn experience any of these, it is incredibly difficult for them to “notify” anyone, difficult for the parents to see or understand the reason behind a newborns cries, and difficult for physicians to see these signs in infants. Majority of physicians are not educated or trained to fully examine an infant in discomfort for vaccine related symptoms. Instead, they are most likely to dismiss any vaccination link.
The following are from the vaccine product insert:
* Clinical Pharmacology: “little is known about the metabolic fate of Vitamin K”. * Contraindication: “Hypersensitivity to any component of this medication”. * Precautions: “Studies of carcinogenicity, mutagenesis, or impairment of fertility have not been conducted with phytonadione.” * Pediatric Use: “Hemolysis, jaundice, and hyperbiliruminemia in newborns, particularly in premature infants, may be related to the dose of phytonadione.” * Adverse reactions: “Deaths have occurred after intravenous administration…The possibility of allergic sensitivity should be kept in mind…Hyperbilirubinemia has been observed in the newborn following administration of phytonadione…” Newborns are not pre-screened for allergic hypersensitivity….
Update, new information. Added 2/16/2015
The rise in life-threatening food anaphylaxis in children coincided with significant changes to the pediatric injection and vaccination schedules of the affected countries: injection of the Vitamin K1 prophylaxis (containing legume oil) became routine in the mid-1980s; the novel conjugate vaccine Hib B that was soon rolled into an unprecedented 5 vaccines in one needle and delivered to babies without benefit of long term study. The injected adjuvants and toxoids and food proteins designed to provoke the immune system also increased the risk of provoking allergy. Allergy is an evolved defense against acute toxicity.
This information was taken from Merck vaccine manufacturer, who also make this injection.
Ingredients: Phytondione 2 or 10mgs, polyoxyethylated fatty acid 70mgs (the data sheet didn’t say where the fatty acid was derived from, but one type of oral brand has bovine gall bladder fatty acid in it, so I assume similar here), dextrose, benzyl alcohol and water.
Other brands such as the one by Roche Pharmaceuticals, may have varying ingredients. Roche’s also contains hydrochloric acid.
Hospira Inc’s version contains aluminium.
Warnings: This injection should be administered subcutaneously (just under the skin) because severe reactions including fatalities have occurred immediately after intramuscular (deep muscle) and intravenous injection (via a drip). Those reactions include hypersensitivity, anaphylactic shock, and cardiac and respiratory arrest.
Benzyl Alcohol as a preservative as been associated with toxicity in newborns (Writer’s comment: why are they then using it in an injection meant for newborns?)
Adverse Reactions: Deaths have occurred after intramuscular and intravenous injection, ‘flushing’ sensations, dizziness, rapid and weak pulse, profuse sweating, hypotension, dyspnea, cyanosis, pain, swelling at the injection site, allergic sensitivity, scleroderma like skin lesions that persist for long periods. Hyperbilirubinemia has occurred in newborns following the administration of vitamin K injection (jaundice).
This drug has not been tested to see if it is carcinogenic (causes cancer),whether it mutates or if it impairs fertility. It is not known whether it can cause fetal harm or whether it is excreted in human milk.
Hypersensitivity to any of the injection’s ingredients. (Writer’s comment: how would they know, since they give it to newborns with no medical history?).
It is interesting to note that vitamin K injections are given intramuscularly even though some manufacturer’s such as Merck say this is dangerous.
Hospira’s data sheet also says this:
‘Benzyl alcohol has been reported to be associated with a fatal “Gasping Syndrome” in premature infants.
WARNING: This product contains aluminium that may be toxic. Aluminium may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they required large amounts of calcium and phosphate solutions, which contain aluminium.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminium at greater than 4 to 5 mcg/kg/day accumulate aluminium at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.’
In 1970, a study was undertaken to see what the risk factors were for childhood cancers. 16,193 babies were studied who had all been born in April 1970. 99 children developed cancer by the age of 10 in the control group and 33 children in the other group. The researchers found that when babies had received vitamin K in the first week of life, their risk of cancer increased three fold. They had not been looking at vitamin K specifically and did not expect to see such an association, so they approached Roche Pharmaceuticals, asking them to do a further trial. They initially refused, until stories about vitamin K and cancer forced them into a corner, and, determined to prove the safety of their product, they began a new study.
588 healthy children and 195 children with cancer were studied. All of these children had been born at one of two hospitals in Bristol. One hospital used oral vitamin K drops and the other used the injection. The researchers found a two fold increase in childhood Leukaemia among those who had received the injection and stated that as many as 980 cases of childhood Leukaemia were caused by the vitamin K injection every year in the UK alone.
Newer studies have been done as recently as 1998 which seem to confirm this. Two studies in the British Medical Journal in that year found that there was a two fold risk of Leukaemia among 1-6 year old’s who had been given the injection at birth, and that there was a ‘significant risk’ of all cancers after the shot.
An Alternative View Of Vitamin K Deficiency
Some medical professionals question whether newborns are actually deficient in vitamin K or whether in fact this is their normal level. Levels have been described as low due to the comparison with adult levels of the vitamin, but this doesn’t make a lot of sense, since newborns and adults are not compared in other areas. For instance, in weight and nutritional requirements. Drugs are also measured differently with lower amounts given to babies.
All babies have this universally ‘low’ level of vitamin K, so surely that would point to it being normal? Normality is based on what is seen in the majority of cases. Perhaps babies need less vitamin K than we do?
According to Archives of Disease in Childhood, 1997, a baby given a vitamin K injection receives 300 times more vitamin than is recommended for an adult and has a 9000 times higher blood plasma level. This may be why some babies then develop jaundice, as an overdose effect of the drug. Bilirubin is a natural by-product which is formed during the body’s normal break down of red blood cells. It is excreted by the liver. Jaundice happens when there is an excess of bilirubin and the liver is unable to properly cleanse the blood, i.e. liver overload. As babies receive such a huge dose of vitamin K, combined with other toxic ingredients in the shot, this liver overload isn’t surprising.
In turn, jaundice can cause kernicterus (brain damage from high bilirubin levels) and haemolysis (destruction of red blood cells), as reported in journals such as the British Journal of Obstetrics and Gynaecology, 1996.
The Truth About Breast Milk
Breast milk undoubtedly gets a bad press in the vitamin K deficiency argument, with doctors and drug manufacturer’s both suggesting that breast milk is ‘too low’ in vitamin K. Just as with vaccines, it is another step to undermine the mother, by suggesting that she is not good enough for her baby, and in ensuring reliance on drugs from birth.
There are many other factors to consider, such as whether the baby has fed and how often he has breast fed, what his overall condition is like, whether he has been exposed to antibiotics.
Studies have shown that:
• Breast fed babies whose mothers ate leafy green vegetables while pregnant, did not get VKDB
• Breast fed babies whose mothers were supplemented with vitamin K tablets while pregnant did not get VKDB
• There are higher levels of vitamin K in colostrum, the baby’s first milk, so it is really important that he gets to drink colostrum as soon as possible. A study in the British Medical Journal in 1992 showed that babies who had unrestricted access to the breast immediately after birth, and who had breast fed before they were 24 hours old, did not get VKDB.
Protecting Your Baby From Vitamin K Deficiency Bleeding
1. Don’t take medications while pregnant. If you are epileptic and on anti-seizure medication, talk to your doctor to see if it is possible to alter your drugs. Don’t take antibiotics unless there is a life threatening emergency.
2. Don’t drink alcohol during pregnancy.
3. Eat plenty of leafy green vegetables and fresh foods.
4. Avoid junk foods, and in particular, fats and margarine. Margarine contains butylated hydroxytoluene, which is an inhibitor of vitamin K.
5. Opt for a natural birth. Drugs in childbirth can make the baby unwell or drowsy, interfere with breast feeding and increase the risk of VKDB. Say no to a forceps delivery. You don’t have to have them, even in difficulty, there are other ways to help the baby into the world.
6. Delay the cord clamping. Leave your baby attached to his cord until it has stopped pulsing, or longer.
7. Breast feed your baby immediately after he is born. If he won’t feed, keep offering. If he is ill and cannot suckle, ensure he gets breast milk through a tube soon after he is born.
8. If you have a son, DON’T circumcise him! Research has shown that circumcision can cause heavy bleeding and lead to VKDB.
9. If you are considering giving artificial vitamin K supplementation, choose an oral brand rather than the injection. It is less stressful for the baby and it hasn’t been linked to cancer. Check ingredients carefully. Some may contain animal products, phenols or aluminium.
10. Consider having a natural vitamin K supplement in pregnancy and while you are nursing your child, as this won’t have the same risk of side-effects as the ones manufactured by the pharmaceutical industry.
Sources used for this article:
Information on VKDB came from source 1.
1. Joint statement and recommendations on
Vitamin K administration to newborn infants to prevent vitamin K deficiency bleeding in infancy.
National Health and Medical Research Council
Paediatric Division of the Royal Australasian College of Physicians
Royal Australian and New Zealand College of Obstetrics and Gynaecology
Royal Australian College of General Practitioners
Australian College of Midwives Inc
2. Merck and Co. Manufacturers data sheet for Aquamephyton vitamin K injection, dated February 2002. http://www.fda.gov/medwatch/SAFETY/2003/03Jun_PI/AquaMEPHYTON_PI.pdf
3. Hospira Inc manufacturer’s information http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=1448
4. Roche Phrmaceutical’s Manufacturer’s data sheet, dated July 2006. http://www.betterhealth.vic.gov.au/bhcv2/bhcmed.nsf/pages/rockonmm/$File/rockonmm.pdf
5. Golding J, Paterson M and Kinlen L. Factors associated with childhood cancer in a national cohort study. Brit. J Cancer 1990;62:304-8.
6. Greenwood R. Vitamin K and childhood cancer. MIDIRS 1994;4(3):258-9.
7. Greer F, Marshall S, Cherry J and Suttie J. Vitamin K status of lactating mothers, human milk, and breast-feeding infants. Pediatrics 1991;88(4);751-6.
8. British Medical Journal, 316:189-193, Jan 17, 1998
9. Passmore S, Draper G, Brownbill P, Kroll M. Ecological studies of relation between hospital policies on neonatal vitamin K administration and subsequent occurrence of childhood cancer. BMJ 1998;316:184-9
10. Meyer T and Angus J. The effect of large doses of Synkavit in the newborn. Arch Dis Child 1956;31:212-5 in, Ruby, C. Vitamin K: a historical perspective. MIDIRS 1997;7(3):362-4.
11. New Ethicals Compendium; 3c: 303-304.
12. Hall M. and Pairaudeau P. The routine use of vitamin K in the newborn. Midwifery 1987;3(4):170-7
13. O’Connor M. and Addiego J. Use of oral vitamin K1 to prevent hemorrhagic disease of the newborn infant. J Pediatr 1986;108:616-9.
14. Hathaway W. New insights on Vitamin K. Hematol Oncol Clin North Am 1987;1(3):367-379.
15. Golding J, Greenwood R, Birmingham K. et al. Childhood cancer, intramuscular vitamin K and pethidine given during labour. BMJ 1992;305 (6849):341-6.
16. Henderson-Smart, D. Giving vitamin K to newborn infants: a therapeutic dilemma. MJA 1996;165:414-5.
Written by Joanna Karpasea-Jones.