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Jana,

Mind if I ask who your midwife is? :)

in Wesley Chapel, FL

Re: Re: vitamin k

>

>

> How did you refuse eye drops and PKU??? I have delivered 9 in SC and 1 in

TN

> and the laws in both states require them. PKU tests for 4 other problems

in

> both of these states. My midwives have used the eye ointment just maybe

> accidentally missed the eye???? ael was an un-assisted home birth

and

> he got an infection and my doc asked if " they " put any ointment/drops in.

> Wrote me scrip and said this or breastmilk will clear it up.

>

> Also, why refuse the testing??

>

>

> Love and Blessings,

> Ellen

> ladylumbee@...

> I believe that what is right is not always popular and what is popular is

> not always right.

>

> HELP FREE LEONARD PELTIER

> Wrongfully Imprisoned for 25 years

> http://www.freepeltier.org/

>

> Learn more about the CROATAN/LUMBEE Indians

> http://www.lumbee.org/index2.htm

>

>

>

>

>

>

>

>

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I can't remember for sure, it has been so long, but I believe I wrote out

something (a " birth plan " I think it was called), which I believe my ob

signed, stating what I agreed to and did not agree to. I believe I did not

get the PKU or vitamin K or silver nitrate. The first time, I had an

emergency caesarian, but had made arrangements ahead of time, so as far as I

know they were honored. I tried to make sure the baby was with me at all

times - but after the (general anesthesia) cesarean was out of it for

awhile. (The second time, I had a VBAC and didn't let my son out of my

sight.) Sandy from Alaska

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE

IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS

REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE

CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION

WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE

MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.

Re: Re: vitamin k

I delivered via caesarian at St. Luke's Hospital in Texas. I refused the

PKU and TO MY KNOWLEDGE it was not done. Though I have heard that some

hospitals do what they want anyway. I believe they were telling me to take

the baby to the pediatrician for the PKU after I was discharged from the

hospital.

Kathleen

In a message dated 6/12/2001 10:04:36 AM Central Daylight Time,

dina.mason@... writes:

> I delivered in Tx at a hospitol with a midwife. I refused eyedrops with

no

> problem. But there was NO WAY to get out of the PKU. I would love to

hear

> more if it possible. Just in case there is another baby in the future for

> me.

>

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silver nitrate

Most states do not use this anymore. They use antibiotic ointment.

Still lots of bad stuff.

Love and Blessings,

Ellen

ladylumbee@...

I believe that what is right is not always popular and what is popular is

not always right.

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I had 2 babaies at home and no one called me! I think a lot has to do with

political climate? We are a backwater community. And in addition, 13 yo dd is

transferring to new school and of course wanted vax record. I think we just

signed a paper at other 3 schools. They called school nurse and she's checking

into it. So we must be the only exempting family at the school. Very polite

tho(maybe because I had my eyes and face in ! LOL )

I am not a medical professional

nor do I portray one on T.V.

(but my husband,Mike,is!)

Please visit our website www.goldenprideweb.com/drmikeandlaurie for natural

vitamins,nutrients,and herbs. NEW!!! The FLORIDA DIET

Also, to save time,space,taste, and waste, shop at

www.my.tupperware.com/LaurieLand for your source of Tupperware products and

recipes

Laurie<Oh boldml@...

mother to 5 birthgoddess to 3 VBAC's,including 1 complete waterbirth(way

cool),BF and non-vaxxed,2 girls and 3 natural boys

I delivered at home in California and did not have the PKU testing. I

received phone calls and letters from Oakland Childrens Hospital offering

free testing ,

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I actually had a team , but the one I am speaking of is Claudette

Coughenour.

Re: Re: vitamin k

> Jana,

> Mind if I ask who your midwife is? :)

> in Wesley Chapel, FL

>

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Hmm, don't know her. My last two babies were born at home with Tregillus

and Brownstein of Countryside Birthing Place. We did do the PKU but I

don't think we were exactly legal. We waited a week after birth and did it just

once instead of twice. The ped wasn't happy but the babies were. :)

Re: Re: vitamin k

> Jana,

> Mind if I ask who your midwife is? :)

> in Wesley Chapel, FL

>

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lucasjt@... writes:

<< I have 2 new midwives and they both believe in routine Vitamin K just in

case. I don't want to give this routinely--it feels the same as " lets just

give the vaccination routinely " . Any thoughts or good links? >>

I don't know if this was written by lucasjt@... or who:

Here are my thoughts: The routine use of vitamin K was coincidental with the

rise in jaundice in newborns. Vitamin K affects the liver. Vitamin K is not

normally needed by babies, and generally, their bodies are able to produce

enough (it doesn't take much) by the end of the first week of life, along

with the mother's bm, that's enough. My daughter reacted to the shot. It

shut down her liver. Her bili shot up to 18 by her 3rd day. Through the

whole mess, we ended up back in emergency, spending a week + in children's,

and 30+ days of daily blood draws. I was told at the time, the jaundice was

a " normal " reaction. the disease they are trying to prevent (inability of

the blood to clot) is genetic, and found in less than 1 in 200,000. If you

have a history of bleeders in your family, the shot is probably necessary.

Most people, however, don't need it. Here are some of the links I have left:

<A HREF= " http://www.birthpsychology.com/messages/vitamink/vitamink.html " >Vita

min K</A> -- geesh. Sorry. I'll put some of the bith ones up, and perhaps

they'll link to the vitamin k: <A

HREF= " http://ahsc.arizona.edu/~msrgsn/pract/praclist.htm " >MSRGSNet/Newborn

Screening Practitioner's Man...</A> // <A

HREF= " http://users.aol.com/kristachan/prenatal.htm " >Prenatal Testing...Do you

" need " it?</A> // <A HREF= " http://detnews.com/menu/stories/32348.htm " >Pren

atal Care: Ultrasounds should be reserved...</A> // <A

HREF= " http://www.birthpsychology.com/messages/push/push.html " > " Push " !/ " Don't

Push " !</A> // <A

HREF= " http://www.birthpsychology.com/messages/washing/washing.html " >Washing

the Baby</A> // <A

HREF= " http://www.birthpsychology.com/messages/eye/eye.html " >Prophylactic Eye

Treatment</A> // <A

HREF= " http://www.efn.org/~djz/birth/birthindex.html#topics " >Midwifery,

Pregnancy. Birth, Childbirth, Brea...</A> // <A

HREF= " http://www.birthpsychology.com/messages/intro.html " >Standard Birth

Procedures</A> // <A HREF= " http://home.hkstar.com/~joewoo/safecamp.htm " >Ul

trasound and Delayed Speech</A>

Hope this helps. You are right. It should never be " routine " . And it

should never be given " just becuase " , or " just in case " , or even as a " safety

precaution " . the numbers don't warrant this type of intervention, and it

generally causes reactions in most babies (jaundice) to varying degrees. l

look at it this way: up to my daughter's generation, no one in my family had

had jaundice (my mother had 6 kids, the other families were as large). In my

dd's generation, all the babies but one have had jaundice - several severely

- except one. My son. I refused the Vit K. What's sad is, most parents

don't recognize that they're even having a reaction, or it is explained away

as something else. i was lucky to have a doctor who told us ahead of time

about the shot. I refused it, but the hospital disregarded my instructions.

se la vie.

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In a message dated 7/22/00 8:07:18 AM Central Daylight Time,

camermer@... writes:

<< This is not true, unfortunately. Formula is fortified with tremendous

amounts of vitamin K to prevent a K deficiency. This may not necessarily be

safe, nor what nature intended.

Vitamin K deficiency bleeding does not occurr often, but on the rare

occasions that it does it occurs mostly in breastfed babies (where mothers

are deficient or on medication). >>

Vitamin K in formula is chemically made. The body does not, therefore,

readily absorb it... hence the " tremendous " amounts necessary to get the job

done. I'm not sure that Vitamin K is absorbed anyway, it must be made by the

body using other " ingredients " . Very little vitamin k is needed to " do the

job " . Most babies will begin to develop it within 5 to 8 days after birth

(one of the reasons circ's are done at this time and not always immediately

following birth). The body must produce it's own vitamin k, the breastmilk

only helps. Vitamin K deficiency is genetic. 1 in 200,000 or more babies

will have this predisposition. Very small number. And most middle class

parents will know that they have a " bleeder " problem in their family. You

can also have a test done. This is the one shot our doctor recommended

AGAINST. It is totally unneccessary for healthy people and in over 1,200

births he claimed it caused more problems than good (my daughter was one).

And those problems were in babies that didn't need the shot in the first

place. It is generally low income mothers whose children have the

deficiencies, mostly because they can't afford the medical care that would've

given them a clue. For those people who are planning on circumcising, the

hospital will almost always insist on the shot - unless you are going to wait

the week. I believe there are several websites (in addition to books) that

explain this. Here are some of mine:

<A HREF= " http://www.birthpsychology.com/messages/vitamink/vitamink.html " >Vita

min K</A> oops. I only see one. Well, it's a start.

Carol

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Vaccination Information & Choice Network, Nevada City CA & UK

$$ Donations to help in the work - accepted by Paypal account

vaccineinfo@...

(go to http://www.paypal.com) or by mail

PO Box 1563 Nevada City CA 95959 530-740-0561 Voicemail in US

http://www.nccn.net/~wwithin/vaccine.htm

ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. THE

DECISION TO VACCINATE IS YOURS AND YOURS ALONE.

Well Within's Earth Mysteries & Sacred Site Tours

http://www.nccn.net/~wwithin

International Tours, Homestudy Courses, ANTHRAX & OTHER Vaccine Dangers

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This article came from Edda West's fine newsletter. She posted it at my

request some weeks back when vit k was discussed

---gary

------------------

Vitamin K

By Karin Rothville DipCBEd.

For the last 40 or 50 years, it has become a generally accepted fact that

vitamin K prevents haemorrhagic disease of the newborn, and routine

administration of vitamin K to all newborns has been recommended.3, 6,

21, 34, 72 This recommendation has been questioned because results

released in 1990 from a study by Golding and colleagues26 in the UK

showed a two to three times increased risk of childhood cancers,

especially leukaemia, in children given prophylactic drugs (usually

intramuscular vitamin K) in their first week. A further study in 1992

seemed to confirm this risk.25

There was widespread anxiety among parents when these findings were

published. Parents were, understandably, reluctant to have their baby

receive a substance that could predispose it to cancer in childhood, and

many health workers were also reluctant to give, without prescription, a

possibly cancer-causing substance to prevent a disease that few, if any,

of them had ever seen. These concerns are not the first time that vitamin

K safety has been questioned. So, what is the controversy about vitamin

K? And does it predispose babies to childhood cancer?

WHAT IS VITAMIN K AND WHAT DOES IT DO?

Vitamin K is a fat-soluble substance which triggers off the

blood-clotting process. Blood clotting is a complex process and can be

described as a sequence of three stages, requiring up to 12 different

coagulation factors.72 The liver needs vitamin K to synthesise four of

these factors. Vitamin K is also needed for the formation of other

proteins found in plasma, bone and kidney.33, 58

As with other fat-soluble vitamins, a normal flow of bile and pancreatic

juice is necessary for digestion, and the presence of dietary fat,

especially short-chain fatty acids, enhances absorption. Absorbed vitamin

K is transported via the lymph into the systemic circulation.58

Normally, a significant portion (up to 55%) of absorbed vitamin K is

excreted so the amount in the body is small and its turnover is rapid

(about 30 hours).58 Vitamin K is stored and re-utilised in the body for

3-4 weeks.33

Vitamin K is found in many foods. Leafy, dark green and deep yellow

vegetables are the best sources.58 Alfalfa18 is a good source; and milk

and dairy products, eggs, cereals, fruits and other vegetables also

provide small but significant amounts. As the liver of adults contains

about equal amounts of plant and animal forms of Vitamin K, it is assumed

that vitamin K is produced in the intestinal tract by bacterial flora.

One of the reasons given for the low levels of vitamin K in newborn

babies is because their gut has not yet been colonised by the required

bacteria.

Recommended daily dietary intakes of vitamin K58CategoryAgeAmount

((g)Infants0 – 110Children1 – 3154 – 6207 – 1025Adolescents11 – 143015 –

1835Adult Male19 – 70+45Adult Female19 – 70+35Pregnancy+ 10Lactating+ 20

The dietary requirements for vitamin K in infants and children are

estimates and are based on weight and growth rates as compared to adults.

Many unsupplemented breasfed infants do not show clinical signs of

vitamin K deficiency on intakes of less than 3 (g daily and the mean

requirement for infants is estimated to be 5 (g daily based on weight.

The higher amount of 10(g is recommended for prevention of Haemorrhagic

Disease of the Newborn.58

WHAT IS HAEMORRHAGIC DISEASE OF THE NEWBORN?

Haemorrhagic Disease of the Newborn (HDN) is a bleeding disorder

associated with low levels of vitamin K in newborn babies. It was first

defined in 1894 by Townsend69 as spontaneous external or internal

bleeding occurring in newborn infants not due to trauma, accident or

inherited bleeding disorders such as haemophilia. Previously, there were

no generally agreed upon criteria to determine causes of haemorrhaging,

so any diagnosis was based solely on the opinion of the attendant medical

personnel.

Infants are born with low levels of vitamin K23 compared to adults and

this is termed ‘vitamin K deficiency’. Up to 50% of babies develop this

‘vitamin K deficiency’, but bleeding occurs in only a fraction of these

cases.37 In most it starts after birth, becomes

Page 2

progressively more severe over 48-60 hours, then spontaneously corrects

itself by 72-120 hours.9

HDN has always been rare – in Britain where maternity units practised a

selective policy of vitamin K administration, the incidence was no more

than 1 in 20,000 in the years 1972-80. Estimates for late onset HDN are

4-8 per 100,000.45 Incidence also seems to vary from country to country.

HDN is divided into three categories: Early onset HDN occurs in the first

24 hours. It is very rare and mainly associated with mothers who have

taken anticonvulsant, antibiotic, antituberculous or anticoagulant drugs

during pregnancy. Classic HDN occurs in the first week after birth. It is

manifested by the oozing of blood from the intestines, the nose, the cord

site and broken skin sites. Bruising at sites where there has been no

trauma can also appear. Late onset HDN occurs after the first week, with

a peak incidence between the second and sixth weeks, and about half the

cases present with intracranial bleeding (bleeding into the brain).

WHAT ARE THE RISK FACTORS FOR HDN?

There has been some debate over the years as to whether or not HDN is

actually caused by vitamin K deficiency. Certainly, giving vitamin K does

arrest bleeding in the majority of cases, but this does not mean that

vitamin K deficiency causes HDN. One may as well say that an antibiotic

deficiency causes bacterial infection. There is also no consensus as to

what level of vitamin K in plasma protects against HDN. Some researchers

have found no evidence of vitamin K deficiency in babies in their

studies43, 49 and other factors have also been suggested.52, 73, 74

Most, if no all, of the reported cases of late onset HDN have presented

with problems which affect the baby’s ability to absorb or utilise

vitamin K.45, 56 These include: hepatitis, cystic fibrosis, chronic

diarrhoea, bile duct atresia, alpha-1-antitrypsin deficiency, coeliac

disease of insufficient plasma transport capacity. Subclinical

cytomegalovirus has also been implicated. Vitamin K-responsive bleeding

syndrome has been well documented after antibiotic therapy, especially

with cyclosporins.33

There are other factors which place the newborn at higher risk. These

include pre-term birth (as the liver is very immature), low birth weight,

instrumental or traumatic delivery, bruised or bleeding in the first few

days after birth, requiring surgery or circumcision, taking inadequate

feeds and breastfeeding.33

BREASTFEEDING – WHY IS IT A RISK?

Several authors have noted the higher incidence of HDN in solely

breastfed babies.9, 30 The incidence has been quoted as 1 in 1200.30

Studies comparing breastmilk with formula and cow’s milk have shown that

breastmilk is lower in vitamin K.22, 28, 32 Breastmilk substitutes are

heavily supplemented with vitamin K, however, it is possible that, like

iron, vitamin K is biologically more available to the baby from

breastmilk, and so such high levels are not necessary.

Measured levels of vitamin K in breastmilk seemed to vary depending on

the type of measurement used; however, they all come out lower than cow’s

milk. Fournier22 and Greer28 found levels of around 8-9(g/l, which would

mean that if a baby was taking in about 500ml per day, it would be

getting the recommended 3-5(g daily.

Vitamin K content and availability are greater in the hind milk because

of its higher fat content and vitamin K levels are also higher in

colostrum.32 As an extra plus, breastmilk contains thromboplastin, one of

the factors in blood clotting.18

Vitamin K levels in the breastmilk rise markedly in response to the

mother eating vitamin K rich foods or taking vitamin K supplements.29, 54

Nishiguchi found no cases of low vitamin K levels in breastfed infants

whose mothers had been given supplements, as opposed to infants who had

only been given 1 or 2 doses of oral vitamin K.54

Unrestricted access to the breast in the early days after birth is

important, due to the higher levels of vitamin K in colostrum. The

importance of early feeding has been recognised since the 1940’s. Babies

who have been fed within their first 24 hours have significantly better

coagulation times than babies not fed until after 24 hours.24

It is essential that, to receive the full complement of vitamin K in

breastmilk, the baby completely finishes one breast before being offered

the other. Any practice that involves restricting either the baby’s time

at the breast or the number of feeds will not allow the baby to receive

optimum amounts of vitamin K and will also prolong the time it takes for

the baby’s intestine to be colonised by friendly, vitamin K manufacturing

bacteria.

THE HISTORY OF VITAMIN K USE TO PREVENT HDN.

The search for the cause of HDN began in 1913 when Whipple82 postulated

that a lack of prothrombin activity could be a cause of HDN. In 1929,

Henrik Dam14 noticed that chicks fed a fat-free diet suffered

subcutaneous and intramuscular haemorrhages, which could be prevented if

the chicks were fed seeds, cereals and green, leafy plants. Dam described

the condition as a vitamin deficiency and named the deficient vitamin

‘vitamin K’, from the Danish word ‘koagulation’.

Research in 19378 found that prothrombin times in normal neonates were

between 30-60% adult levels, falling to 15-30% on day two, and then

gradually rising again until about day 10. This research led to the

continuing belief that these low levels in the newborn are a deficiency

and need to be corrected.

In 1939, vitamin K1 was isolated from alfalfa by Dam, for which he later

received the Nobel Prize, along with Doisy, who isolated vitamin

K2.45 Further research in 1939 by Waddell and Guerry81 found that low

plasma prothrombin levels could be elevated by the administration of oral

vitamin K.

Armed with this ‘proof’ that vitamin K deficiency caused HDN, vitamin K

was synthesised and various trials were commenced

Page 3

to ascertain which was the most effective amount and route to use in

prophylaxis.

It is difficult for us to assess these trials nowadays as they were

mostly neither double blind nor well controlled. The dosage of vitamin K

given, the route of administration and the time of administration all

varied. In many cases, the conclusions did not seem to match the

results.72

Some of the studies assessed the effect on neonatal vitamin K levels if

the mother was given vitamin K during labour.72 Results varied, with the

effectiveness of the vitamin K given depending on how soon the woman gave

birth and the dosage given. More recent studies have shown increases in

cord blood levels where mothers were supplemented antenatally with

vitamin K.1, 66 Two showed a significant difference between the

supplemented and unsupplemented groups and found that the effect of

prenatal vitamin K persisted until the fifth day after birth.1

Because of the variations in results from these early studies, further

research focussed on treating the baby after birth. One particular study

done in 194231 was intended to determine the minimal effective oral dose

of Synkavite (K3), a water-soluble synthetic form of vitamin K. The

results showed that very small daily doses were effective and that a dose

of 5(g daily would probably prevent the development of HDN, except in

early onset cases. The study also found that 1.25mg was effective in

lowering an excessively high prothrombin time to normal. However, the

author admitted that several workers found prothrombin deficiencies in

babies with no abnormal bleeding.

By 1950, most maternity units had a policy of giving infants oral vitamin

K (usually Synkavite) immediately after birth.70 This prevented the fall

in prothrombin levels that occurred in the first few days and,

presumably, the risk of excessive bleeding. This risk was higher in male

babies because of routine circumcision, and, indeed, vitamin K proved to

be of great clinical value in preventing post-circumcision bleeding.75

Then, in the mid-1950’s, reports of increased jaundice and kernicterus

(brain damage caused by high bilirubin levels) associated with vitamin K

prophylaxis began circulating. Reviews of maternity units found that some

were giving Synkavite in doses exceeding 50mg.70 It was established that

high doses of Synkavite caused haemolysis (destruction of red blood

cells) and high serum bilirubin levels.48

Researchers and medical professionals queried the safety aspects of

vitamin K, and there were many conflicting reports on the appropriate

dosages. Some researchers queried the need for vitamin K at all, quoting

results from studies that showed no difference in prothrombin times or

vitamin K plasma levels between babies that bled and babies that

didn’t.72

Eventually, a newer preparation, intramuscular vitamin K1

(phytomenadione), was developed and approved for use, solely on the

grounds that it appeared to cause less haemolysis. Phytomenadione (trade

names Konakion (Roche) or Aquamephyton (Merck, Sharpe & Dohme)) is a

synthetic petrochemical derived from 2-methyl 1,4-naptha-quinone in a

polyethoxylated castor oil base.18 In the US, polysorbate-80 is used as a

base instead of polyethoxylated castor oil.15

In spite there being no long term trials of these preparations, the

American Academy of Pediatrics recommended that phytomenadione be

administered prophylactically to all newborn babies.72 The use of oral

vitamin K preparations fell out of favour in the USA and the ‘safer’

intramuscular route became the route of choice.

In Britain, after the jaundice scare of the1950’s, many maternity units

began to practice a selective policy, giving vitamin K only to babies at

risk of haemorrhaging. McNinch reported in 1980 that less than half the

maternity units in the UK gave vitamin K to all newborns.47 Some of these

babies were given oral prophylaxis and some were given intramuscular

prophylaxis.

In Germany, almost all newborn infants who required medical care and

instrumental deliveries were given intramuscular vitamin K, and some

healthy newborns also received it.76 Records have not always been kept in

New Zealand hospitals, so it is impossible to say whether or not vitamin

K was given routinely and by which route.17

Although vitamin K use seemed to prevent most cases of HDN, there was

still controversy. Not everyone believed vitamin K deficiency was the

cause of HDN. In 1977, van Doorm et al 52, 73, 74 suggested that HDN

could be caused by a heparin-like inhibitor in the newborn and he

concluded that babies given their first feed soon after birth do not have

a vitamin K deficiency. Other researchers agreed with van Doorn.49 In

1980, Malia et al43 could find no evidence of vitamin K deficiency in

babies in their study and concluded that low levels of vitamin K

dependent clotting factors were due to the immature liver. The authors of

these studies questioned whether vitamin K prophylaxis was really

necessary for healthy newborns.

Then, starting in November 1980, there was a cluster of six cases of HDN

in Britain, all within 17 months.46 Half of these cases were classic HDN,

the other half were a new manifestation of HDN – late onset.

LATE ONSET HDN

Late onset HDN was first reported in 1977.5 It mainly occurs in breastfed

infants and ( to ¾ of cases have an underlying liver disorder or

malabsorption syndrome,15 rather than insufficient dietary intake of

vitamin K. This means the liver cannot adequately synthesise blood

clotting factors or store adequate amounts of vitamin K. Liver function

cannot be easily diagnosed at birth without a range of invasive tests and

thus there exists an unknown risk of haemorrhaging.

Many factors contribute to poor liver function, including hepatitis,

cystic fibrosis, antibiotic therapy, biliary atresia, alpha-1-antitrypsin

deficiency, a-beta-lipoproteinaemia, coeliac disease, chronic diarrhoea

and exposure to pharmacologic agents such as anticonvulsants, rifampin,

isoniazid cephalosporins and coumarin compounds33 When tested, most of

the reported cases of late onset HDN had hepatitis, liver malfunction or

enzyme

Page 4

deficiencies.6, 35, 51, 80

Birkbeck6 believes there are two processes at work – low levels of

prothrombin and vitamin K-dependent clotting factors VII, IX and X at

birth, and a further fall in these in the neonatal period. In his view

the initial low levels are not due to vitamin K deficiency as levels of 2

other non-vitamin K-dependent factors, XI and XII are also often reduced.

Thus, the situation at birth may be simply due to hepatic immaturity.

Birkbeck6 also reports that HDN is almost unknown in central Africa and

he suggests an environmental mechanism as the cause. Associated with

this, a discussion paper from the University of Amsterdam42 raises the

idea that by-products of our industrial society such as PCBs, PCDDs and

PCDFs are the cause of late onset HDN. These chemicals can induce enzymes

in the liver which cause liver damage and prolong prothrombin time.

Although overseas studies have reported contamination of breastmilk by

these pollutants, a NZ Department of Health study on breastmilk reported

that levels of these contaminants were at the lower end of the scale.7

The Health Department is currently conducting another study to see if

levels have changed over the past few years.

There seems to be a seasonal variance, with most cases of late onset HDN

occurring in the warmer months.6 It has been suggested that the mother

could have contracted a viral infection during pregnancy in the colder

months and this has crossed the placenta. Since viruses have an affinity

for the liver and mucous membranes, they can affect intestinal absorption

and liver function.67

Another suggested cause of late onset HDN includes use of the food

antioxidant BHT (butylated hydroxytoluene), which has produced vitamin K

deficiency.68 BHT is present in many processed foods, including

margarine. Our Western diets consist of a lot of processed food, and to

reduce fat intakes, margarine is recommended rather than butter. The

polyunsaturated fat in margarine is an inhibitor of vitamin K

absorption.68 Both of these factors could have an effect on the amount of

vitamin K available to pass through to the baby. A high level of vitamin

K in the mother’s blood is necessary to ensure adequate transplacental

transfer of vitamin K.9, 33 It is important for the baby to have adequate

stores of vitamin K in its liver at birth to prevent bleeding until its

feeding and gut flora are established.

Of the six cases of HDN in Britain in 1980-1982, all were breastfed and

none had received vitamin K at birth.46 Two of the cases were in the

high-risk group – one was born by caesarean section and had an epileptic

mother treated with phenytoin, and the other had an alcoholic mother who

had taken anti-depressants – and obviously should have received vitamin K

at birth.

These cases prompted a call for the re-introduction of routine

prophylaxis. Many opposed the idea of unnecessarily injecting otherwise

healthy babies so studies40, 47, 55, 79 were therefore conducted to

determine whether oral vitamin K was as effective as intramuscular. It

was also proposed that oral vitamin K would be more cost-effective and

thus better suited for use in Third World countries.55 Results of these

studies varied. Some showed that oral vitamin K was effective in

preventing classic haemorrhagic disease but not as effective as

intramuscular vitamin K in preventing late onset HDN.47, 55, 78 Others

found oral as effective, especially a 10 year study conducted on 38,000

infants in Sweden where no cases of HDN were observed over that period.40

Tripp and McNinch reported no cases in 25,000 babies in their maternity

unit where only those at risk were given intramuscular prophylaxis and

the rest oral prophylaxis.70

In spite of these findings that oral vitamin K prophylaxis was not

effective in preventing late onset HDN, it continued to be used in

British maternity units, especially for low risk infants.

RISKS OF VITAMIN K PROPHYLAXIS

Konakion ampoules contain phenol, propylene glycol38 and polyethoxylated

castor oil as a non-ionic surfactant. Studies in animals given

polyethoxylated castor oil have shown a severe anaphylactic reaction

associated with histamine release. Strong circumstantial evidence

implicates polyethoxylated castor oil in similar reactions in humans.

Polyethoxylated castor oil, when given to patients over a period of

several days, can also produce abnormal lipoprotein electrophoretic

patterns, alterations in blood viscosity and erythrocyte aggregation (red

blood cell clumping). Individuals sensitive to this base are

contraindicated from using Konakion. New Ethicals Compendium also warns

that the use of Konakion can cause jaundice and kernicterus in infants.53

Other listed side effects include flushing, sweating, cyanosis, a sense

of chest constriction, and peripheral vascular collapse. Local cutaneous

and subcutaneous changes may occur in areas of repeated intramuscular

injections.

This synthetic, injectable vitamin K formulation was never subjected to a

randomised, controlled trial. In new drugs that are to be used for

prophylaxis, the usual risk/benefit analysis does not apply, since the

individual is not ill. The ethical principle of non-maleficence (primum

non nocere – first do no harm) applies and the trials must thus be larger

in order to identify any previously unrecognised side effects.65 Since

this did not happen, nor was there any long term follow up, we actually

have little idea of the effects of this drug on newborn babies.

The risks of injecting vitamin K into a newborn baby are nerve or muscle

damage as the preparation must be injected deeply into the muscle, not

subcutaneously under the skin. There is also the documented risk of

injecting the baby with the syntocinon intended for the mother.30, 70 As

stated in the product information,53 infants can suffer from jaundice or

kernicterus (brain damage from a build-up of bile pigments in the brain)

from Konakion. Infants who have the enzyme deficiency G6PD (glucose 6

phosphate dehydrogenase) are at particular risk from vitamin K.30 The

other risk factor is the possible increased chance of childhood cancer.

THE LINK BETWEEN CHILDHOOD CANCER AND INTRAMUSCULAR VITAMIN K

In 1970, a national cohort study of 16,193 infants born in one week in

April was begun in Britain.26 This study was to test

Page 5

hypotheses about childhood cancers and their associated factors.

Thirty-three of the children had developed cancer by age 10 and were

compared with 99 control children, matched on maternal age, parity and

social class. One of the unlooked-for risk factors was the administration

of prophylactic drugssuch as vitamin K in the first week after birth – a

nearly three-fold risk. This association fitted no prior hypothesis and

the authors recommended that their finding be tested in another series of

cases.

The authors of the study approached Roche, the manufacturers of Konakion,

for funding for a further trial to examine the findings more closely.

Roche was not interested until, a few months later, the media reported

the results of the study and that vitamin K given to babies might cause

childhood cancer. Roche then decided to fund a new study.27

The new study25 was a case-control study of 195 children with cancer born

at either of two hospitals in Bristol, England, compared with 588 healthy

children also born at these hospitals. One hospital predominantly gave

vitamin K orally and the other intramuscularly. The authors found a

nearly two-fold risk of leukaemia in children who had received

intramuscular vitamin K.

These findings were extremely worrying. Golding calculated that the extra

cases of leukaemia caused by vitamin K injection could be as many as 980

in the UK alone.25 These results were supported by reports of the

potential carcinogenicity of vitamin K from Israels et al, who suggested

that low vitamin K levels in the newborn protect against the risk of

mutations during a period of rapid cell growth and division.39 Pizer et

al did not find any association between the route of vitamin K

administration and mutations in cells but concluded that his study was

too small to show any real effect.62 Another study reported no increase

in abnormalities in newborn infants, but, with only 12 infants, the study

was too small to show any real effect.10 It is worth noting that after an

intramuscular dose of vitamin K, the baby’s plasma levels are almost 9000

times the normal adult levels.47 It has also been suggested that the

cancer-causing agent could be a metabolite, N-epoxide, or some other

component of the solution other than vitamin K itself.15

Golding’s study was criticised by many. One of the reasons was that the

authors had to make assumptions for some cases, as the information on

vitamin K administration was not clearly recorded. In spite of this,

expert epidemiologists considered that the results were plausible and so

could not be lightly dismissed.15 Further studies were proposed to answer

the question of cancer and vitamin K.

In 1993, results from three retrospective studies on vitamin K and

childhood cancer were published. The studies were done in the USA,

Denmark and Sweden.41, 57, 19 These studies, although large, did not

confirm the association between intramuscular vitamin K and childhood

cancer. One of the studies not only showed no association between IM

vitamin K and childhood cancer, it also showed no association between

maternal smoking and childhood cancer, a finding totally at odds with the

results from many other studies.19 The other two studies were also not

comparable to the British study. One because of differences in type of

vitamin K given41 and the other because of the use of birth cohorts with

differing regimens of vitamin K usage.57

Because of the design flaws in these studies, there was still a need for

further case-control studies. Results from two were published in 1996.2,

77 They had carefully matched controls and more accurate information on

whether vitamin K had been given or not, and by which route. One of the

studies2 reported no association between intramuscular vitamin K and

childhood cancer and the other77 found a risk of leukaemia, but only when

cases were compared with local controls (i.e. from the same hospital) and

not with controls randomly selected from the whole area under study.

This, although suggestive, was not followed up but dismissed as a chance

finding related to multiple testing.

The suggestion was then put forward that, as these studies had failed to

show a definite association between intramuscular vitamin K and childhood

cancers, worries about any potential cancer risk should be abandoned.83

At that time, four more studies on vitamin K and cancer were in

progress.44, 59, 60, 61 The results from these four studies were

published in 1998. Two of them failed to confirm any increased risk of

childhood cancers.44 61 One of the other studies showed a twofold risk of

acute lymphoblastic leukaemia among 1-6 year olds,59 the other showed a

significant risk for all cancers.60

So, the jury is still out on whether there is an increased risk of

childhood leukaemia with the intramuscular form of vitamin K. Some

recommend that intramuscular vitamin K should still be used, as the risk

of leukaemia “seems more hypothetical than real”.76 Others believe that

public confidence in IM vitamin K has been severely shaken and will be

difficult to restore fully. They recommend an oral regimen similar to

that used in the Netherlands of 25(g daily, given by the mother. This

would avoid the grossly unphysiological peaks of vitamin K from both the

IM route and the present oral route.71

ORAL VITAMIN K VS INTRAMUSCULAR

The two main problems with giving vitamin K orally are that there is no

licensed oral formulation, meaning that babies receive the intramuscular

form orally, and that compliance with three oral doses is poor as many

doctors and midwives are reluctant to give an unlicensed formula.13 The

use of unlicensed preparations may theoretically expose professionals to

litigation in the event of prophylactic failure or unforeseen adverse

events.2

Roche, the manufacturers of Konakion, state that they do not recommend

the administration of Konakion solution orally.63 Their reasons are: that

they have no clinical studies to support oral use, phenol, which has been

reported to be an irritant to newborns mouths, is used as a preservative,

the variability in the production of bile salts in newborns may affect

absorption, that Konakion given orally has a small association with

anaphylactic reactions.

Page 6

The preparation was also unpleasant to taste and babies were inclined to

spit it out82 or to vomit it back up. Only about half of an orally

administered dose is absorbed.47 Even so, the plasma concentrations in

babies who were given oral vitamin K reached 300 times the adult levels,

before dropping off slightly after about 24 hours.47

After the publication of Golding’s studies, further trials were done on

oral vitamin K prophylaxis and whether it gave longer term protection. In

1992, Cornelissen11 found plasma vitamin K concentrations were higher in

the group given IM vitamin K than the oral group, but blood

coagulability, activities of factors VII, X and PIVKA-II concentrations

showed no differences. By 3 months follow-up, vitamin K levels had

dropped in both groups but more in the oral group. He suggests that

neither give long term protection. One would assume that babies should be

producing their own vitamin K by 3 months and, if not, what other

mechanism could be hindering this process.

Von Kries et al78 studied repeated oral vitamin K prophylaxis in Germany,

with 3x 1 mg doses and found that it was not as effective as a 1mg

intramuscular dose at birth. Another study by Cornelissen et al12

reported on the effectiveness of differing regimens of oral vitamin K in

four different countries – the Netherlands, Germany, Switzerland and

Australia (two differing regimes). In the Netherlands, babies are given

25 (g daily oral vitamin K for 3 months with I mg given at birth either

orally for healthy newborns or intramuscularly for unwell babies. In

Germany, the regime is 3 x 1 mg oral doses as was also the case in

Australia from 1993 to 1994. In Switzerland 2 oral doses of a new

‘mixed-micellar’ oral vitamin K is given. The Netherlands had the lowest

failure rate – 0 per 100,000. In Australia, where the regime was changed

in 1994 from oral to IM, the failure rate was 1.5 per 100,000 for oral

and 0.9 per 100,000 for IM, showing that 3 oral doses are less effective

at preventing late onset HDN than one IM dose of vitamin K. Even if Roche

are persuaded to bring the mixed-micellar preparation into New Zealand,

results from Switzerland (failure rate of 1.2 per 100,000)12 show that

further study needs to be done on the most effective timing of the doses.

If New Zealand parents wish their baby to receive oral vitamin K, the

recommended regimen is for 3 x 1mg doses, 1 at birth, 1 at 5 days and 1

at 6 weeks.6, 20 It is up to parents to ensure that their baby receives

all 3 doses if they choose this form of prophylaxis.

CONCLUSION

It would seem an anachronism that babies are born with a deficiency of

such an essential vitamin and require supplementation. In fact, although

there have been many studies on differing aspects of vitamin K

prophylaxis, there has only been one39 on the possible reasons for and

the advantages (if any) of the physiological levels of vitamin K in

newborns.

The risks of prophylaxis for the majority of babies who are at low risk

of HDN are also not understood. As plasma vitamin K levels in newborns

reach 300 times normal adult levels for oral and almost 9000 times for IM

vitamin K47, some research needs to be done on the effects this may have.

Studies have shown that physiological levels of vitamin K maintain a

careful balance between coagulation and anti-coagulation and we have no

idea what the effects of upsetting that delicate balance would be.

The number of children currently developing cancer during childhood is

much higher than the number developing a life threatening or permanently

disabling problem as a result of late onset HDN. The risk of childhood

cancer is estimated to be 1.4 per 1000, from the 1970 British cohort. If

IM vitamin K caused cancer, there would be 100 extra cases of cancer per

case of HDN prevented.16 This could mean that giving IM vitamin K to

every baby would be doing more harm than good.36

The decision rests on parents’ shoulders – the link between intramuscular

vitamin K and childhood cancer has not been definitively proved, nor has

it been completely disproved. It may be that an oral regimen as suggested

by Tripp and McNinch71 could be the answer to the dilemma. If this is the

case, then Roche needs to be lobbied to make the European preparations

available in New Zealand. In the meantime, the choice is between no

vitamin K, with the mother being aware of her dietary intake of vitamin

K, an oral regimen or the intramuscular formulation.

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This is so true of ALL the vitamins in formula. It's all synthetic. A bunch of

synthetic vitamins in a cows milk base.. it's a wonder human babies survive on

it at all!!

It never fails to irk me when people try to pull the old " Well formula has so

much more -fill in the blank with your nutrient content- than breastmilk, so

breastfed babies need vitamin supplement " or other such BS. Hello, do they NOT

realize the reason formula is so overkill is because babies can't utilize most

of what's in it? Breastmilk is so digestible, and it's nutrients are in a form

that is immediately available to a human baby.... so it doesn't HAVE to contain

10 times what a baby needs! And what exactly does the poor baby's body do with

all the unusable excess in formula? It struggles with an immature digestive

system, and body to sort all the crap out. Then people go on to wonder why their

formula fed babies have such bad reflux, and colic, and so many other problems

that are rare in breastfed babies.

It just nuts!

Back to Vit. K... my second son was born at home without a medical attendant (by

choice, I wasn't about to have another child in a hospital and I decided I

didn't want to deal with a midwife either). My labor with him was long because

his rather large head was transverse (as opposed to presenting in a crown first

position, he was presenting with his 15 inch head <and 10 lb 8 oz body)

completely sideways... just wouldn't work that way), and it took several hours

to get him to change position. He had a lot of bruising on one side of his head

due to repeatedly being pushed up against my pubic bone during contractions. I'm

sure at a hospital they would have insisted on the Vit. K shot because of

'trauma'. He obviously never had one, and is a wild little hooligan 19 month old

today!! He did however, latch on almost immediately after birth and nursed for

well over an hour. He was a champion nurser right from the start. It was so

sweet... after laboring all afternoon, and all night, and through the next

morning with him.... when he finally popped out he was so wide eyed... and

nursed and just looked at me like 'Wow, how the heck did I get out here'. He

never cried... was never hauled away to be injected with anything...

Ok, I digress... point being... I think Vit K injections are totally pointless.

Hook a baby to a boob...

Liz

----- Original Message -----

From: Sheri Nakken

Vitamin K in formula is chemically made. The body does not, therefore,

readily absorb it... hence the " tremendous " amounts necessary to get the job

done.

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I'm in the UK, Kelsey, where we don't use the eye drops (to the best of my

knowledge) but we do get Vitamin K thrust at us. My own personal opinion is

that it is mostly irrelevant unless you have family history of haemorrhagic

disease, or blood-clotting problems, or liver disease. There have not been

many studies linking it to childhood cancers, but one was enough for me.

Breastfeeding also passes on a good amount of Vit K to newborns, but the

danger is past by about ten days, I think. I refused it, was given hell by

the midwives, but stood my ground. I can't speak for the US but if you

instruct your maternity unit that you don't want it administered, and they

do so anyway, you have a case of assault on your hands. The other option is

not to let your baby out of your sight, or have a homebirth!

Love, light and peace,

Sue

" Education is an admirable thing. But it is well to remember from time to

time that nothing that is worth knowing can be taught. " - Wilde

> vitamin k

>

>

> Can anyone tell me the importance of giving a vitamin k shot to a

> new born

> baby?

> Also, I'm wondering what is the importance of the silver that they put in

> their eyes.

> What steps can someone take to keep the hospital from doing this

> to your baby?

>

>

> Thanks,

> Kelsey

>

>

>

>

>

>

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I'm in Canada, and the eye gel is to prevent the baby from getting chlamidia

passed to it through the birth canal from you. If you have already been

tested for chlamidida and know that you don't have it, then there is NO

reason to put the baby through that. Have the doctors ever put that junk

into their own eyes, what does it feel like?, how do they know it's not

actually causing discomfort/irratation etc....

I had to sign a waiver saying that I did not want the drops, and it was

fine, but I did have a homebirth too, which took the hospital/doctors power

away! Good luck. Beth

>From: " Sue " <angelmouse55@...>

>Reply-Vaccinations

><Vaccinations >

>Subject: RE: vitamin k

>Date: Sun, 5 May 2002 02:36:52 +0100

>

>I'm in the UK, Kelsey, where we don't use the eye drops (to the best of my

>knowledge) but we do get Vitamin K thrust at us. My own personal opinion

>is

>that it is mostly irrelevant unless you have family history of haemorrhagic

>disease, or blood-clotting problems, or liver disease. There have not been

>many studies linking it to childhood cancers, but one was enough for me.

>Breastfeeding also passes on a good amount of Vit K to newborns, but the

>danger is past by about ten days, I think. I refused it, was given hell by

>the midwives, but stood my ground. I can't speak for the US but if you

>instruct your maternity unit that you don't want it administered, and they

>do so anyway, you have a case of assault on your hands. The other option

>is

>not to let your baby out of your sight, or have a homebirth!

>

>Love, light and peace,

>

>Sue

>

> " Education is an admirable thing. But it is well to remember from time to

>time that nothing that is worth knowing can be taught. " - Wilde

>

>

> > vitamin k

> >

> >

> > Can anyone tell me the importance of giving a vitamin k shot to a

> > new born

> > baby?

> > Also, I'm wondering what is the importance of the silver that they put

>in

> > their eyes.

> > What steps can someone take to keep the hospital from doing this

> > to your baby?

> >

> >

> > Thanks,

> > Kelsey

> >

> >

> >

> >

> >

> >

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The major reason for the eye gel is to prevent blindness in your child is

you have a STD like gonorrhea. They use silver nitrate but I believe they

mostly use erythromyocin? now. Which makes no sense if you are tested neg

for this(blood work during pregnancy) and are in a monogamous relationship.

it wasn't too long ago this was discussed so looking in the past

files/archives should prove helpful.

Laurie>Oh

-----

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Did I miss it? or did this article not mention early cord clamping

and Vitamin K deficiency? The physician that delivered my baby at

home did not think Vitamin K was necessary with an untraumatic birth

where the cord was left to pulsate before cutting it.

> This article came from Edda West's fine newsletter.

> ------------------

>

> Vitamin K

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<<I take vitamin K now and that is supposed to clot blood because Dr D said

that O's have clotting problems.>>

Vitamin K is also excellent for bone health.

Dianne in LA

0+ non-secretor

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My mother and I are both type O's and we do not have a clotting problem at

all. My mother has to take blood thinners. Our bodies just seem to store

all the Vit K.

Deb

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This article came from Edda West's fine newsletter.

------------------

Vitamin K

By Karin Rothville DipCBEd.

For the last 40 or 50 years, it has become a generally accepted fact that

vitamin K prevents haemorrhagic disease of the newborn, and routine

administration of vitamin K to all newborns has been recommended.3, 6,

21, 34, 72 This recommendation has been questioned because results

released in 1990 from a study by Golding and colleagues26 in the UK

showed a two to three times increased risk of childhood cancers,

especially leukaemia, in children given prophylactic drugs (usually

intramuscular vitamin K) in their first week. A further study in 1992

seemed to confirm this risk.25

There was widespread anxiety among parents when these findings were

published. Parents were, understandably, reluctant to have their baby

receive a substance that could predispose it to cancer in childhood, and

many health workers were also reluctant to give, without prescription, a

possibly cancer-causing substance to prevent a disease that few, if any,

of them had ever seen. These concerns are not the first time that vitamin

K safety has been questioned. So, what is the controversy about vitamin

K? And does it predispose babies to childhood cancer?

WHAT IS VITAMIN K AND WHAT DOES IT DO?

Vitamin K is a fat-soluble substance which triggers off the

blood-clotting process. Blood clotting is a complex process and can be

described as a sequence of three stages, requiring up to 12 different

coagulation factors.72 The liver needs vitamin K to synthesise four of

these factors. Vitamin K is also needed for the formation of other

proteins found in plasma, bone and kidney.33, 58

As with other fat-soluble vitamins, a normal flow of bile and pancreatic

juice is necessary for digestion, and the presence of dietary fat,

especially short-chain fatty acids, enhances absorption. Absorbed vitamin

K is transported via the lymph into the systemic circulation.58

Normally, a significant portion (up to 55%) of absorbed vitamin K is

excreted so the amount in the body is small and its turnover is rapid

(about 30 hours).58 Vitamin K is stored and re-utilised in the body for

3-4 weeks.33

Vitamin K is found in many foods. Leafy, dark green and deep yellow

vegetables are the best sources.58 Alfalfa18 is a good source; and milk

and dairy products, eggs, cereals, fruits and other vegetables also

provide small but significant amounts. As the liver of adults contains

about equal amounts of plant and animal forms of Vitamin K, it is assumed

that vitamin K is produced in the intestinal tract by bacterial flora.

One of the reasons given for the low levels of vitamin K in newborn

babies is because their gut has not yet been colonised by the required

bacteria.

Recommended daily dietary intakes of vitamin K58CategoryAgeAmount

((g)Infants0 – 110Children1 – 3154 – 6207 – 1025Adolescents11 – 143015 –

1835Adult Male19 – 70+45Adult Female19 – 70+35Pregnancy+ 10Lactating+ 20

The dietary requirements for vitamin K in infants and children are

estimates and are based on weight and growth rates as compared to adults.

Many unsupplemented breasfed infants do not show clinical signs of

vitamin K deficiency on intakes of less than 3 (g daily and the mean

requirement for infants is estimated to be 5 (g daily based on weight.

The higher amount of 10(g is recommended for prevention of Haemorrhagic

Disease of the Newborn.58

WHAT IS HAEMORRHAGIC DISEASE OF THE NEWBORN?

Haemorrhagic Disease of the Newborn (HDN) is a bleeding disorder

associated with low levels of vitamin K in newborn babies. It was first

defined in 1894 by Townsend69 as spontaneous external or internal

bleeding occurring in newborn infants not due to trauma, accident or

inherited bleeding disorders such as haemophilia. Previously, there were

no generally agreed upon criteria to determine causes of haemorrhaging,

so any diagnosis was based solely on the opinion of the attendant medical

personnel.

Infants are born with low levels of vitamin K23 compared to adults and

this is termed ‘vitamin K deficiency’. Up to 50% of babies develop this

‘vitamin K deficiency’, but bleeding occurs in only a fraction of these

cases.37 In most it starts after birth, becomes

Page 2

progressively more severe over 48-60 hours, then spontaneously corrects

itself by 72-120 hours.9

HDN has always been rare – in Britain where maternity units practised a

selective policy of vitamin K administration, the incidence was no more

than 1 in 20,000 in the years 1972-80. Estimates for late onset HDN are

4-8 per 100,000.45 Incidence also seems to vary from country to country.

HDN is divided into three categories: Early onset HDN occurs in the first

24 hours. It is very rare and mainly associated with mothers who have

taken anticonvulsant, antibiotic, antituberculous or anticoagulant drugs

during pregnancy. Classic HDN occurs in the first week after birth. It is

manifested by the oozing of blood from the intestines, the nose, the cord

site and broken skin sites. Bruising at sites where there has been no

trauma can also appear. Late onset HDN occurs after the first week, with

a peak incidence between the second and sixth weeks, and about half the

cases present with intracranial bleeding (bleeding into the brain).

WHAT ARE THE RISK FACTORS FOR HDN?

There has been some debate over the years as to whether or not HDN is

actually caused by vitamin K deficiency. Certainly, giving vitamin K does

arrest bleeding in the majority of cases, but this does not mean that

vitamin K deficiency causes HDN. One may as well say that an antibiotic

deficiency causes bacterial infection. There is also no consensus as to

what level of vitamin K in plasma protects against HDN. Some researchers

have found no evidence of vitamin K deficiency in babies in their

studies43, 49 and other factors have also been suggested.52, 73, 74

Most, if no all, of the reported cases of late onset HDN have presented

with problems which affect the baby’s ability to absorb or utilise

vitamin K.45, 56 These include: hepatitis, cystic fibrosis, chronic

diarrhoea, bile duct atresia, alpha-1-antitrypsin deficiency, coeliac

disease of insufficient plasma transport capacity. Subclinical

cytomegalovirus has also been implicated. Vitamin K-responsive bleeding

syndrome has been well documented after antibiotic therapy, especially

with cyclosporins.33

There are other factors which place the newborn at higher risk. These

include pre-term birth (as the liver is very immature), low birth weight,

instrumental or traumatic delivery, bruised or bleeding in the first few

days after birth, requiring surgery or circumcision, taking inadequate

feeds and breastfeeding.33

BREASTFEEDING – WHY IS IT A RISK?

Several authors have noted the higher incidence of HDN in solely

breastfed babies.9, 30 The incidence has been quoted as 1 in 1200.30

Studies comparing breastmilk with formula and cow’s milk have shown that

breastmilk is lower in vitamin K.22, 28, 32 Breastmilk substitutes are

heavily supplemented with vitamin K, however, it is possible that, like

iron, vitamin K is biologically more available to the baby from

breastmilk, and so such high levels are not necessary.

Measured levels of vitamin K in breastmilk seemed to vary depending on

the type of measurement used; however, they all come out lower than cow’s

milk. Fournier22 and Greer28 found levels of around 8-9(g/l, which would

mean that if a baby was taking in about 500ml per day, it would be

getting the recommended 3-5(g daily.

Vitamin K content and availability are greater in the hind milk because

of its higher fat content and vitamin K levels are also higher in

colostrum.32 As an extra plus, breastmilk contains thromboplastin, one of

the factors in blood clotting.18

Vitamin K levels in the breastmilk rise markedly in response to the

mother eating vitamin K rich foods or taking vitamin K supplements.29, 54

Nishiguchi found no cases of low vitamin K levels in breastfed infants

whose mothers had been given supplements, as opposed to infants who had

only been given 1 or 2 doses of oral vitamin K.54

Unrestricted access to the breast in the early days after birth is

important, due to the higher levels of vitamin K in colostrum. The

importance of early feeding has been recognised since the 1940’s. Babies

who have been fed within their first 24 hours have significantly better

coagulation times than babies not fed until after 24 hours.24

It is essential that, to receive the full complement of vitamin K in

breastmilk, the baby completely finishes one breast before being offered

the other. Any practice that involves restricting either the baby’s time

at the breast or the number of feeds will not allow the baby to receive

optimum amounts of vitamin K and will also prolong the time it takes for

the baby’s intestine to be colonised by friendly, vitamin K manufacturing

bacteria.

THE HISTORY OF VITAMIN K USE TO PREVENT HDN.

The search for the cause of HDN began in 1913 when Whipple82 postulated

that a lack of prothrombin activity could be a cause of HDN. In 1929,

Henrik Dam14 noticed that chicks fed a fat-free diet suffered

subcutaneous and intramuscular haemorrhages, which could be prevented if

the chicks were fed seeds, cereals and green, leafy plants. Dam described

the condition as a vitamin deficiency and named the deficient vitamin

‘vitamin K’, from the Danish word ‘koagulation’.

Research in 19378 found that prothrombin times in normal neonates were

between 30-60% adult levels, falling to 15-30% on day two, and then

gradually rising again until about day 10. This research led to the

continuing belief that these low levels in the newborn are a deficiency

and need to be corrected.

In 1939, vitamin K1 was isolated from alfalfa by Dam, for which he later

received the Nobel Prize, along with Doisy, who isolated vitamin

K2.45 Further research in 1939 by Waddell and Guerry81 found that low

plasma prothrombin levels could be elevated by the administration of oral

vitamin K.

Armed with this ‘proof’ that vitamin K deficiency caused HDN, vitamin K

was synthesised and various trials were commenced

Page 3

to ascertain which was the most effective amount and route to use in

prophylaxis.

It is difficult for us to assess these trials nowadays as they were

mostly neither double blind nor well controlled. The dosage of vitamin K

given, the route of administration and the time of administration all

varied. In many cases, the conclusions did not seem to match the

results.72

Some of the studies assessed the effect on neonatal vitamin K levels if

the mother was given vitamin K during labour.72 Results varied, with the

effectiveness of the vitamin K given depending on how soon the woman gave

birth and the dosage given. More recent studies have shown increases in

cord blood levels where mothers were supplemented antenatally with

vitamin K.1, 66 Two showed a significant difference between the

supplemented and unsupplemented groups and found that the effect of

prenatal vitamin K persisted until the fifth day after birth.1

Because of the variations in results from these early studies, further

research focussed on treating the baby after birth. One particular study

done in 194231 was intended to determine the minimal effective oral dose

of Synkavite (K3), a water-soluble synthetic form of vitamin K. The

results showed that very small daily doses were effective and that a dose

of 5(g daily would probably prevent the development of HDN, except in

early onset cases. The study also found that 1.25mg was effective in

lowering an excessively high prothrombin time to normal. However, the

author admitted that several workers found prothrombin deficiencies in

babies with no abnormal bleeding.

By 1950, most maternity units had a policy of giving infants oral vitamin

K (usually Synkavite) immediately after birth.70 This prevented the fall

in prothrombin levels that occurred in the first few days and,

presumably, the risk of excessive bleeding. This risk was higher in male

babies because of routine circumcision, and, indeed, vitamin K proved to

be of great clinical value in preventing post-circumcision bleeding.75

Then, in the mid-1950’s, reports of increased jaundice and kernicterus

(brain damage caused by high bilirubin levels) associated with vitamin K

prophylaxis began circulating. Reviews of maternity units found that some

were giving Synkavite in doses exceeding 50mg.70 It was established that

high doses of Synkavite caused haemolysis (destruction of red blood

cells) and high serum bilirubin levels.48

Researchers and medical professionals queried the safety aspects of

vitamin K, and there were many conflicting reports on the appropriate

dosages. Some researchers queried the need for vitamin K at all, quoting

results from studies that showed no difference in prothrombin times or

vitamin K plasma levels between babies that bled and babies that

didn’t.72

Eventually, a newer preparation, intramuscular vitamin K1

(phytomenadione), was developed and approved for use, solely on the

grounds that it appeared to cause less haemolysis. Phytomenadione (trade

names Konakion (Roche) or Aquamephyton (Merck, Sharpe & Dohme)) is a

synthetic petrochemical derived from 2-methyl 1,4-naptha-quinone in a

polyethoxylated castor oil base.18 In the US, polysorbate-80 is used as a

base instead of polyethoxylated castor oil.15

In spite there being no long term trials of these preparations, the

American Academy of Pediatrics recommended that phytomenadione be

administered prophylactically to all newborn babies.72 The use of oral

vitamin K preparations fell out of favour in the USA and the ‘safer’

intramuscular route became the route of choice.

In Britain, after the jaundice scare of the1950’s, many maternity units

began to practice a selective policy, giving vitamin K only to babies at

risk of haemorrhaging. McNinch reported in 1980 that less than half the

maternity units in the UK gave vitamin K to all newborns.47 Some of these

babies were given oral prophylaxis and some were given intramuscular

prophylaxis.

In Germany, almost all newborn infants who required medical care and

instrumental deliveries were given intramuscular vitamin K, and some

healthy newborns also received it.76 Records have not always been kept in

New Zealand hospitals, so it is impossible to say whether or not vitamin

K was given routinely and by which route.17

Although vitamin K use seemed to prevent most cases of HDN, there was

still controversy. Not everyone believed vitamin K deficiency was the

cause of HDN. In 1977, van Doorm et al 52, 73, 74 suggested that HDN

could be caused by a heparin-like inhibitor in the newborn and he

concluded that babies given their first feed soon after birth do not have

a vitamin K deficiency. Other researchers agreed with van Doorn.49 In

1980, Malia et al43 could find no evidence of vitamin K deficiency in

babies in their study and concluded that low levels of vitamin K

dependent clotting factors were due to the immature liver. The authors of

these studies questioned whether vitamin K prophylaxis was really

necessary for healthy newborns.

Then, starting in November 1980, there was a cluster of six cases of HDN

in Britain, all within 17 months.46 Half of these cases were classic HDN,

the other half were a new manifestation of HDN – late onset.

LATE ONSET HDN

Late onset HDN was first reported in 1977.5 It mainly occurs in breastfed

infants and ( to ¾ of cases have an underlying liver disorder or

malabsorption syndrome,15 rather than insufficient dietary intake of

vitamin K. This means the liver cannot adequately synthesise blood

clotting factors or store adequate amounts of vitamin K. Liver function

cannot be easily diagnosed at birth without a range of invasive tests and

thus there exists an unknown risk of haemorrhaging.

Many factors contribute to poor liver function, including hepatitis,

cystic fibrosis, antibiotic therapy, biliary atresia, alpha-1-antitrypsin

deficiency, a-beta-lipoproteinaemia, coeliac disease, chronic diarrhoea

and exposure to pharmacologic agents such as anticonvulsants, rifampin,

isoniazid cephalosporins and coumarin compounds33 When tested, most of

the reported cases of late onset HDN had hepatitis, liver malfunction or

enzyme

Page 4

deficiencies.6, 35, 51, 80

Birkbeck6 believes there are two processes at work – low levels of

prothrombin and vitamin K-dependent clotting factors VII, IX and X at

birth, and a further fall in these in the neonatal period. In his view

the initial low levels are not due to vitamin K deficiency as levels of 2

other non-vitamin K-dependent factors, XI and XII are also often reduced.

Thus, the situation at birth may be simply due to hepatic immaturity.

Birkbeck6 also reports that HDN is almost unknown in central Africa and

he suggests an environmental mechanism as the cause. Associated with

this, a discussion paper from the University of Amsterdam42 raises the

idea that by-products of our industrial society such as PCBs, PCDDs and

PCDFs are the cause of late onset HDN. These chemicals can induce enzymes

in the liver which cause liver damage and prolong prothrombin time.

Although overseas studies have reported contamination of breastmilk by

these pollutants, a NZ Department of Health study on breastmilk reported

that levels of these contaminants were at the lower end of the scale.7

The Health Department is currently conducting another study to see if

levels have changed over the past few years.

There seems to be a seasonal variance, with most cases of late onset HDN

occurring in the warmer months.6 It has been suggested that the mother

could have contracted a viral infection during pregnancy in the colder

months and this has crossed the placenta. Since viruses have an affinity

for the liver and mucous membranes, they can affect intestinal absorption

and liver function.67

Another suggested cause of late onset HDN includes use of the food

antioxidant BHT (butylated hydroxytoluene), which has produced vitamin K

deficiency.68 BHT is present in many processed foods, including

margarine. Our Western diets consist of a lot of processed food, and to

reduce fat intakes, margarine is recommended rather than butter. The

polyunsaturated fat in margarine is an inhibitor of vitamin K

absorption.68 Both of these factors could have an effect on the amount of

vitamin K available to pass through to the baby. A high level of vitamin

K in the mother’s blood is necessary to ensure adequate transplacental

transfer of vitamin K.9, 33 It is important for the baby to have adequate

stores of vitamin K in its liver at birth to prevent bleeding until its

feeding and gut flora are established.

Of the six cases of HDN in Britain in 1980-1982, all were breastfed and

none had received vitamin K at birth.46 Two of the cases were in the

high-risk group – one was born by caesarean section and had an epileptic

mother treated with phenytoin, and the other had an alcoholic mother who

had taken anti-depressants – and obviously should have received vitamin K

at birth.

These cases prompted a call for the re-introduction of routine

prophylaxis. Many opposed the idea of unnecessarily injecting otherwise

healthy babies so studies40, 47, 55, 79 were therefore conducted to

determine whether oral vitamin K was as effective as intramuscular. It

was also proposed that oral vitamin K would be more cost-effective and

thus better suited for use in Third World countries.55 Results of these

studies varied. Some showed that oral vitamin K was effective in

preventing classic haemorrhagic disease but not as effective as

intramuscular vitamin K in preventing late onset HDN.47, 55, 78 Others

found oral as effective, especially a 10 year study conducted on 38,000

infants in Sweden where no cases of HDN were observed over that period.40

Tripp and McNinch reported no cases in 25,000 babies in their maternity

unit where only those at risk were given intramuscular prophylaxis and

the rest oral prophylaxis.70

In spite of these findings that oral vitamin K prophylaxis was not

effective in preventing late onset HDN, it continued to be used in

British maternity units, especially for low risk infants.

RISKS OF VITAMIN K PROPHYLAXIS

Konakion ampoules contain phenol, propylene glycol38 and polyethoxylated

castor oil as a non-ionic surfactant. Studies in animals given

polyethoxylated castor oil have shown a severe anaphylactic reaction

associated with histamine release. Strong circumstantial evidence

implicates polyethoxylated castor oil in similar reactions in humans.

Polyethoxylated castor oil, when given to patients over a period of

several days, can also produce abnormal lipoprotein electrophoretic

patterns, alterations in blood viscosity and erythrocyte aggregation (red

blood cell clumping). Individuals sensitive to this base are

contraindicated from using Konakion. New Ethicals Compendium also warns

that the use of Konakion can cause jaundice and kernicterus in infants.53

Other listed side effects include flushing, sweating, cyanosis, a sense

of chest constriction, and peripheral vascular collapse. Local cutaneous

and subcutaneous changes may occur in areas of repeated intramuscular

injections.

This synthetic, injectable vitamin K formulation was never subjected to a

randomised, controlled trial. In new drugs that are to be used for

prophylaxis, the usual risk/benefit analysis does not apply, since the

individual is not ill. The ethical principle of non-maleficence (primum

non nocere – first do no harm) applies and the trials must thus be larger

in order to identify any previously unrecognised side effects.65 Since

this did not happen, nor was there any long term follow up, we actually

have little idea of the effects of this drug on newborn babies.

The risks of injecting vitamin K into a newborn baby are nerve or muscle

damage as the preparation must be injected deeply into the muscle, not

subcutaneously under the skin. There is also the documented risk of

injecting the baby with the syntocinon intended for the mother.30, 70 As

stated in the product information,53 infants can suffer from jaundice or

kernicterus (brain damage from a build-up of bile pigments in the brain)

from Konakion. Infants who have the enzyme deficiency G6PD (glucose 6

phosphate dehydrogenase) are at particular risk from vitamin K.30 The

other risk factor is the possible increased chance of childhood cancer.

THE LINK BETWEEN CHILDHOOD CANCER AND INTRAMUSCULAR VITAMIN K

In 1970, a national cohort study of 16,193 infants born in one week in

April was begun in Britain.26 This study was to test

Page 5

hypotheses about childhood cancers and their associated factors.

Thirty-three of the children had developed cancer by age 10 and were

compared with 99 control children, matched on maternal age, parity and

social class. One of the unlooked-for risk factors was the administration

of prophylactic drugssuch as vitamin K in the first week after birth – a

nearly three-fold risk. This association fitted no prior hypothesis and

the authors recommended that their finding be tested in another series of

cases.

The authors of the study approached Roche, the manufacturers of Konakion,

for funding for a further trial to examine the findings more closely.

Roche was not interested until, a few months later, the media reported

the results of the study and that vitamin K given to babies might cause

childhood cancer. Roche then decided to fund a new study.27

The new study25 was a case-control study of 195 children with cancer born

at either of two hospitals in Bristol, England, compared with 588 healthy

children also born at these hospitals. One hospital predominantly gave

vitamin K orally and the other intramuscularly. The authors found a

nearly two-fold risk of leukaemia in children who had received

intramuscular vitamin K.

These findings were extremely worrying. Golding calculated that the extra

cases of leukaemia caused by vitamin K injection could be as many as 980

in the UK alone.25 These results were supported by reports of the

potential carcinogenicity of vitamin K from Israels et al, who suggested

that low vitamin K levels in the newborn protect against the risk of

mutations during a period of rapid cell growth and division.39 Pizer et

al did not find any association between the route of vitamin K

administration and mutations in cells but concluded that his study was

too small to show any real effect.62 Another study reported no increase

in abnormalities in newborn infants, but, with only 12 infants, the study

was too small to show any real effect.10 It is worth noting that after an

intramuscular dose of vitamin K, the baby’s plasma levels are almost 9000

times the normal adult levels.47 It has also been suggested that the

cancer-causing agent could be a metabolite, N-epoxide, or some other

component of the solution other than vitamin K itself.15

Golding’s study was criticised by many. One of the reasons was that the

authors had to make assumptions for some cases, as the information on

vitamin K administration was not clearly recorded. In spite of this,

expert epidemiologists considered that the results were plausible and so

could not be lightly dismissed.15 Further studies were proposed to answer

the question of cancer and vitamin K.

In 1993, results from three retrospective studies on vitamin K and

childhood cancer were published. The studies were done in the USA,

Denmark and Sweden.41, 57, 19 These studies, although large, did not

confirm the association between intramuscular vitamin K and childhood

cancer. One of the studies not only showed no association between IM

vitamin K and childhood cancer, it also showed no association between

maternal smoking and childhood cancer, a finding totally at odds with the

results from many other studies.19 The other two studies were also not

comparable to the British study. One because of differences in type of

vitamin K given41 and the other because of the use of birth cohorts with

differing regimens of vitamin K usage.57

Because of the design flaws in these studies, there was still a need for

further case-control studies. Results from two were published in 1996.2,

77 They had carefully matched controls and more accurate information on

whether vitamin K had been given or not, and by which route. One of the

studies2 reported no association between intramuscular vitamin K and

childhood cancer and the other77 found a risk of leukaemia, but only when

cases were compared with local controls (i.e. from the same hospital) and

not with controls randomly selected from the whole area under study.

This, although suggestive, was not followed up but dismissed as a chance

finding related to multiple testing.

The suggestion was then put forward that, as these studies had failed to

show a definite association between intramuscular vitamin K and childhood

cancers, worries about any potential cancer risk should be abandoned.83

At that time, four more studies on vitamin K and cancer were in

progress.44, 59, 60, 61 The results from these four studies were

published in 1998. Two of them failed to confirm any increased risk of

childhood cancers.44 61 One of the other studies showed a twofold risk of

acute lymphoblastic leukaemia among 1-6 year olds,59 the other showed a

significant risk for all cancers.60

So, the jury is still out on whether there is an increased risk of

childhood leukaemia with the intramuscular form of vitamin K. Some

recommend that intramuscular vitamin K should still be used, as the risk

of leukaemia “seems more hypothetical than real”.76 Others believe that

public confidence in IM vitamin K has been severely shaken and will be

difficult to restore fully. They recommend an oral regimen similar to

that used in the Netherlands of 25(g daily, given by the mother. This

would avoid the grossly unphysiological peaks of vitamin K from both the

IM route and the present oral route.71

ORAL VITAMIN K VS INTRAMUSCULAR

The two main problems with giving vitamin K orally are that there is no

licensed oral formulation, meaning that babies receive the intramuscular

form orally, and that compliance with three oral doses is poor as many

doctors and midwives are reluctant to give an unlicensed formula.13 The

use of unlicensed preparations may theoretically expose professionals to

litigation in the event of prophylactic failure or unforeseen adverse

events.2

Roche, the manufacturers of Konakion, state that they do not recommend

the administration of Konakion solution orally.63 Their reasons are: that

they have no clinical studies to support oral use, phenol, which has been

reported to be an irritant to newborns mouths, is used as a preservative,

the variability in the production of bile salts in newborns may affect

absorption, that Konakion given orally has a small association with

anaphylactic reactions.

Page 6

The preparation was also unpleasant to taste and babies were inclined to

spit it out82 or to vomit it back up. Only about half of an orally

administered dose is absorbed.47 Even so, the plasma concentrations in

babies who were given oral vitamin K reached 300 times the adult levels,

before dropping off slightly after about 24 hours.47

After the publication of Golding’s studies, further trials were done on

oral vitamin K prophylaxis and whether it gave longer term protection. In

1992, Cornelissen11 found plasma vitamin K concentrations were higher in

the group given IM vitamin K than the oral group, but blood

coagulability, activities of factors VII, X and PIVKA-II concentrations

showed no differences. By 3 months follow-up, vitamin K levels had

dropped in both groups but more in the oral group. He suggests that

neither give long term protection. One would assume that babies should be

producing their own vitamin K by 3 months and, if not, what other

mechanism could be hindering this process.

Von Kries et al78 studied repeated oral vitamin K prophylaxis in Germany,

with 3x 1 mg doses and found that it was not as effective as a 1mg

intramuscular dose at birth. Another study by Cornelissen et al12

reported on the effectiveness of differing regimens of oral vitamin K in

four different countries – the Netherlands, Germany, Switzerland and

Australia (two differing regimes). In the Netherlands, babies are given

25 (g daily oral vitamin K for 3 months with I mg given at birth either

orally for healthy newborns or intramuscularly for unwell babies. In

Germany, the regime is 3 x 1 mg oral doses as was also the case in

Australia from 1993 to 1994. In Switzerland 2 oral doses of a new

‘mixed-micellar’ oral vitamin K is given. The Netherlands had the lowest

failure rate – 0 per 100,000. In Australia, where the regime was changed

in 1994 from oral to IM, the failure rate was 1.5 per 100,000 for oral

and 0.9 per 100,000 for IM, showing that 3 oral doses are less effective

at preventing late onset HDN than one IM dose of vitamin K. Even if Roche

are persuaded to bring the mixed-micellar preparation into New Zealand,

results from Switzerland (failure rate of 1.2 per 100,000)12 show that

further study needs to be done on the most effective timing of the doses.

If New Zealand parents wish their baby to receive oral vitamin K, the

recommended regimen is for 3 x 1mg doses, 1 at birth, 1 at 5 days and 1

at 6 weeks.6, 20 It is up to parents to ensure that their baby receives

all 3 doses if they choose this form of prophylaxis.

CONCLUSION

It would seem an anachronism that babies are born with a deficiency of

such an essential vitamin and require supplementation. In fact, although

there have been many studies on differing aspects of vitamin K

prophylaxis, there has only been one39 on the possible reasons for and

the advantages (if any) of the physiological levels of vitamin K in

newborns.

The risks of prophylaxis for the majority of babies who are at low risk

of HDN are also not understood. As plasma vitamin K levels in newborns

reach 300 times normal adult levels for oral and almost 9000 times for IM

vitamin K47, some research needs to be done on the effects this may have.

Studies have shown that physiological levels of vitamin K maintain a

careful balance between coagulation and anti-coagulation and we have no

idea what the effects of upsetting that delicate balance would be.

The number of children currently developing cancer during childhood is

much higher than the number developing a life threatening or permanently

disabling problem as a result of late onset HDN. The risk of childhood

cancer is estimated to be 1.4 per 1000, from the 1970 British cohort. If

IM vitamin K caused cancer, there would be 100 extra cases of cancer per

case of HDN prevented.16 This could mean that giving IM vitamin K to

every baby would be doing more harm than good.36

The decision rests on parents’ shoulders – the link between intramuscular

vitamin K and childhood cancer has not been definitively proved, nor has

it been completely disproved. It may be that an oral regimen as suggested

by Tripp and McNinch71 could be the answer to the dilemma. If this is the

case, then Roche needs to be lobbied to make the European preparations

available in New Zealand. In the meantime, the choice is between no

vitamin K, with the mother being aware of her dietary intake of vitamin

K, an oral regimen or the intramuscular formulation.

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Clin North Am 1987;1(3):367-379. -Smart, D. Giving vitamin K to

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A., Bourchier D and Lees H. Avoidable hazard to New Zealand children:

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Hilgartner, M. Vitamin K and the newborn. New Eng J Med

1993;329(13):957-8. Hull D. Vitamin K and childhood cancer. BMJ

1992;305:326-7. Israels l, Friesen E., Jansen A. and Israels E. Vitamin

K1 increases sister chromatid exchange in vitro in human leukocytes and

in vivo in fetal sheep cells: a possible role for ‘vitamin K deficiency’

in the fetus. Pediatr Res 1991;30:550-3. nsen F, Fielding P, Vinther

S et al. Vitamin K to neonates. Peroral versus intramuscular

administration. Acta Pediatr Scand 1991;80(3):304-7. Klebanoff M, Read J,

Mills J. et al. The risk of childhood cancer after neonatal exposure to

vitamin K. New Eng J Med. 1993;329(13):905-8. Koppe J, Pluim E and Olie

K. Breastmilk, PCBs, dioxins and vitamin K deficiency: discussion paper.

J Royal Soc. Medicine 1989;82:416-419 in, Donley, Joan. Vitamin K in

relation to haemorrhagic disease of the newborn. NZCOM Journal Dec 1992.

Malia R, Preston F and V. Evidence against vitamin K deficiency

in normal neonates. Thromb Haemost 1980;44:159. McKinney P, Juszczak E,

Findlay E, K. Case-control study of childhood leukaemia and cancer

in Scotland: findings for neonatal intramuscular vitamin K. BMJ

1998;316:173-7. McNinch A and Tripp J. Haemorrhagic disease of the

newborn in the British Isles: a two year prospective study. BMJ

1991;303(6810):1105-1109. McNinch A, Orme R and Tripp J. Haemorrhagic

disease of the newborn returns. Lancet 1983;i:1089-90 (abstract). McNinch

A, Upton C, s M et al. Plasma concentrations after oral or

intramuscular vitamin K1 in neonates. Arch Dis Child 1985;60:814-818.

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. Mori P, Bisogni C, Odino

S et al. (letter). Lancet 1977;ii:188. Motohara K, Endo F and Matsuda I.

Screening for late neonatal vitamin K deficiency by acarboxyprothrombin

in dried blood spots. Arch Dis Child 1987;62:370-375. Motz R. Late

haemothorax after oral vitamin K. NZMJ 11 November 1992:459. Muller A.,

van Doorm J and Hemker H. Heparin-like inhibitor of blood coagulation in

normal newborn. Nature 1977;267:616-7. New Ethicals Compendium; 3c:

303-304. Nishiguchi T, Saga K, Sumimoto K. et al. Vitamin K prophylaxis

to prevent neonatal vitamin K deficient intracranial haemorrhage in

Shizuoka prefecture. Brit J Obstet Gynec 1996;103 (11):1078-84. 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. O’Connor M, Livingstone

D, Hannah J. and Wilkins D. Vitamin K deficiency and breastfeeding. Am J

Dis Child 1983;137:601-2 Olsen J, Hertz H, Blinkenberg K. et al. Vitamin

K regimens and incidence of childhood cancer in Denmark. BMJ

1994;308(6933):895-6 in, Greenwood, R. Vitamin K and childhood cancer.

MIDIRS 1994;4(3):258-260 Olson J. Recommended dietary intakes (RDI) of

vitamin K in humans. Am J Clin Nutr 1987;45:687-92. L, Cole M,

Craft A, Hey E. Neonatal vitamin K administration and childhood cancer in

the north of England: retrospective case-control study. BMJ

1998;316:189-93. Passmore S, Draper G, Brownbill P, Kroll M. Case-control

studies of relation between childhood cancer and neonatal vitamin K

administration: retrospective case-control study. BMJ 1998;316:178-84.

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 Pizer

B, Boyse J, Hunt L. and Mott M. Neonatal vitamin K administration and in

vivo somatic mutation. Mutat Res 1995;347:135-9. Roche Products Ltd.

Position statement re: Konakion injection given orally. Roche Products

Ltd. New oral vitamin K formulation for newborns (press release). Welwyn

Garden City, 30 Aug 1996. Ruby . Vitamin K prophylaxis: a

historical perspective. MIDIRS 1997;7(3):362-4. Shearer M. et al. Plasma

vitamin K1 in mothers and their newborn babies. Lancet 1982:460-3 in,

Hathaway, W. New insights on vitamin K. Hematol Oncol Clin North Am

1987;1(3):367-379. son, J. The vitamin K conundrum. Maternity

Alliance Action Newsletter July/August 1992. Suzuki H, Nakao T and Hiraga

K. Vitamin K deficiency in male rats fed diets containing butylated

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J. Vitamin K prophylaxis in the newborn: a position statement of the

Nutrition Committee of the Paediatric Society of New Zealand. NZMJ

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Pediatr 1894;11:559-562 in, Birkbeck J. Vitamin K prophylaxis in the

newborn: a position statement of the Nutrition Committee of the

Paediatric Society of New Zealand. NZMJ 1988;101:421-2. Tripp J. and

McNinch A. Haemorrhagic disease and vitamin K. Arch Dis Child

1987;62:436-7. Tripp J and McNinch A. The vitamin K debacle: cut the

Gordian knot but first do no harm. Arch Dis Child 1998;79:295-299. Vail,

B. Vitamin K prophylaxis and hemorrhagic disease of the newborn. ICEA

Review 1985;9(3). Van Doorm J and Hemker H. Vitamin K deficiency in the

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Hemker, H. Heparin-like inhibitor, not vitamin-K deficiency, in the

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Pritchard J. Observations on the prophylactic use of vitamin K in the

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K and childhood cancer: a population based case-control study in Lower

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and Göbel U. Repeated oral vitamin K prophylaxis in West Germany:

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S, Becker A, Tangermann R and Göbel U. Acarboxyprothrombin activity after

oral prophylactic vitamin K. Arch Dis Child 1987;62: 938-40. Von Kries R,

Shearer M and Göbel U. Vitamin K in infancy. Eur J Pediatr

1988;147:106-12. Waddell W. and Guerry D. The role of vitamin K in the

etiology, prevention and treatment of hemorrhage in the newborn infant. J

Ped 1939;15:802 in, Ruby, C. Vitamin K prophylaxis: a historical

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1994;313(1051):179-180.

--------------------------------------------------------

Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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Guest guest

Hi all,

Just wondering if there are any problems with oral

Vitamin K?

Respectfully

Anya

________________________________________________________________________

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Hi Anya,

I'm in the UK where the medics are a little more laid back about Vit K. I

refused it for my dd as I couldn't see any reason for giving it. Dd wasn't

at high risk of HDN, and I was going to breastfeed. There's adequate vit K

in breastmilk, despite what *they* would have you believe. Vit K has been

associated in two studies with an increased risk of childhood leukaemia,

although these studies have allegedly never been reproduced. Not worth the

risk in my opinion.

Love, light and peace,

Sue

You can't wake a person who is pretending to be asleep. ~ Navajo Proverb

> Re: vitamin K

>

>

> Hi all,

>

> Just wondering if there are any problems with oral

> Vitamin K?

>

> Respectfully

> Anya

>

> ________________________________________________________________________

> Want to chat instantly with your online friends? Get the FREE

> Messenger http://mail.messenger..co.uk

>

>

>

>

>

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Guest guest

Hi Sue,

Thanks for that. What is HDN? Do you know if there's a

difference in oral v's injected vit K as far as risks

go?

Respectfully

Anya

>

> Hi Anya,

>

> I'm in the UK where the medics are a little more

> laid back about Vit K. I

> refused it for my dd as I couldn't see any reason

> for giving it. Dd wasn't

> at high risk of HDN, and I was going to breastfeed.

> There's adequate vit K

> in breastmilk, despite what *they* would have you

> believe. Vit K has been

> associated in two studies with an increased risk of

> childhood leukaemia,

> although these studies have allegedly never been

> reproduced. Not worth the

> risk in my opinion.

>

> Love, light and peace,

>

> Sue

>

> You can't wake a person who is pretending to be

> asleep. ~ Navajo Proverb

________________________________________________________________________

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Injected vitamin K has been associated with childhood leukemia, oral has

not.

Randall Neustaedter OMD, LAc

Classical Medicine Center

1779 Woodside Rd., Suite 201C

Redwood City, CA 94061

650 299-9170

Author of The Vaccine Guide, North Atlantic Books, 2002

Subscribe to my free email newsletter

at www.cure-guide.com

Re: vitamin K

> Hi Sue,

>

> Thanks for that. What is HDN? Do you know if there's a

> difference in oral v's injected vit K as far as risks

> go?

>

> Respectfully

> Anya

> >

> > Hi Anya,

> >

> > I'm in the UK where the medics are a little more

> > laid back about Vit K. I

> > refused it for my dd as I couldn't see any reason

> > for giving it. Dd wasn't

> > at high risk of HDN, and I was going to breastfeed.

> > There's adequate vit K

> > in breastmilk, despite what *they* would have you

> > believe. Vit K has been

> > associated in two studies with an increased risk of

> > childhood leukaemia,

> > although these studies have allegedly never been

> > reproduced. Not worth the

> > risk in my opinion.

> >

> > Love, light and peace,

> >

> > Sue

> >

> > You can't wake a person who is pretending to be

> > asleep. ~ Navajo Proverb

>

> ________________________________________________________________________

> Want to chat instantly with your online friends? Get the FREE

> Messenger http://mail.messenger..co.uk

>

>

>

>

>

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Guest guest

Hi

I haven't got my notes on me just now but if you look at the links

given/net search the issues should come up.

It is in the injection sphere and as such an interest to non vaxing

parents as a number of us choose to avoid this also due to problems

with it, myself included. As some pople have said it appears to

also be mandatory in some areas, not a parental option to

accept/refuse which is an extra concern i think.

The injection/drops contain different issues...the injection, one

large load(overload?) risk of contributing to leukemia and the drops

although safer in that respect (sometimes need to be requested again

sometimes difficult to obtain like requesting various vaccines) and

also in that it is not one immediate load but several smaller doses

they do however contain animal ingredients, also a concern for

vegetarians and also generally putting animal cells etc into human

growing babies, alongside whatever else is in there.

Vitamin K is low in newborns (another issue) but that may be for an

evolutionary reason. Low doesnt necessarily equate with dangerously

low or the need to supplement artificially or otherwise. Who is to

know the mothers level of vitamin k or the childs...it will all vary

and this is not taken into account prior to administration. The

blood clotting argument has its critics.

Further more, if supplementation is decided- it may be preferable to

administer it to the mother who will pass it on through bf either in

vitamin tablet form (more natural) or the best source, natural

food. With this option you can also do it gradually and assess how

much to be transfering. It may be less but that doesn't mean it's

not sufficient.

The hospitals and mws are very keen for you to take it generally. I

said initially no several times then under pressure and repeated

leaflets thrust at me to " inform " me lol, agreed to have the drops

on standby, i wanted drops despite being a vegetarian as this was a

reserve prefered option. This i stated would be for a clear

emergency...a traumatic birth, obvious blood problems at

birth/shortly after (which are the supposed issues requirng it with

little chance otherwise) and they were clear on that. Being at home

i was pretty confident this would not happen and it didnt. I signed

a refusal, had it on my birth plan, told the mws weeks leading up to

the birth and each team mw up to three weeks after including saying

it at least 15 times on the day of birth we were not having it. I

had a home birth, it was not easier to refuse it. It is not even

mandatory here. One mw supported me and my doula who agreed on the

bf element and could see i was not an idiot and was capable of

following my own nutrition or perhaps it was the steadfastness of my

conviction. It was not administered no less because even in not a

good post birth state i wouldve not let it be if it had come to it.

If using powdered milk theres even more vitamin k in there anyway.

How much do babies need? noone can tell you so how can they know if

it needs supplementing or by how much and correspondingly how much

is too much.

No new births of people I've met have even questioned the vit k,

it's only a group of non/selective vaxers and also midwives i know

of that have as they are aware perhaps more of the issues.

Definately worth considering every medical option with a newborn

imo. We dont have the eye drop issue here thank god for one less

thing.

Thats as much as i remember of the issues.

Ambersmum (fine unvaxed, unvit kd, home water birthed, drug free ;D

16ms)

Vaccinations , " Dawn Rice " <dawnrice@c...> wrote:

>

> I am a bit confused. >

> Dawn

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My children were all born at home so vitamin k wasn't an issue for

us, and I have never really looked into it, I was under the

impression that they give it routinely " just in case " your baby

doesn't have the blood clotting factor, when in actual fact in most

cases it is not even an issue. Please correct me if I'm wrong?

Debbie

>

> I am a bit confused. I was not aware that vitamin K was an

> immunization/vaccine. I know it can be give either inner muscular

or orally

> doses) but I was not aware that it was a mandatory thing anywhere

(other

> than the hospital making you think it is). Isn't Vitamin

K....Vitamin K?

> Isn't its purpose to aid in blood clotting because infants don't

have the

> ability to clot for 7 days (or something like that)?

>

> Someone, please clarify. How is vitamin K negative/positive?

>

> Thanks :)

>

> Dawn

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This article came from Edda West's fine newsletter.

------------------

Vitamin K

By Karin Rothville DipCBEd.

For the last 40 or 50 years, it has become a generally accepted fact that

vitamin K prevents haemorrhagic disease of the newborn, and routine

administration of vitamin K to all newborns has been recommended.3, 6,

21, 34, 72 This recommendation has been questioned because results

released in 1990 from a study by Golding and colleagues26 in the UK

showed a two to three times increased risk of childhood cancers,

especially leukaemia, in children given prophylactic drugs (usually

intramuscular vitamin K) in their first week. A further study in 1992

seemed to confirm this risk.25

There was widespread anxiety among parents when these findings were

published. Parents were, understandably, reluctant to have their baby

receive a substance that could predispose it to cancer in childhood, and

many health workers were also reluctant to give, without prescription, a

possibly cancer-causing substance to prevent a disease that few, if any,

of them had ever seen. These concerns are not the first time that vitamin

K safety has been questioned. So, what is the controversy about vitamin

K? And does it predispose babies to childhood cancer?

WHAT IS VITAMIN K AND WHAT DOES IT DO?

Vitamin K is a fat-soluble substance which triggers off the

blood-clotting process. Blood clotting is a complex process and can be

described as a sequence of three stages, requiring up to 12 different

coagulation factors.72 The liver needs vitamin K to synthesise four of

these factors. Vitamin K is also needed for the formation of other

proteins found in plasma, bone and kidney.33, 58

As with other fat-soluble vitamins, a normal flow of bile and pancreatic

juice is necessary for digestion, and the presence of dietary fat,

especially short-chain fatty acids, enhances absorption. Absorbed vitamin

K is transported via the lymph into the systemic circulation.58

Normally, a significant portion (up to 55%) of absorbed vitamin K is

excreted so the amount in the body is small and its turnover is rapid

(about 30 hours).58 Vitamin K is stored and re-utilised in the body for

3-4 weeks.33

Vitamin K is found in many foods. Leafy, dark green and deep yellow

vegetables are the best sources.58 Alfalfa18 is a good source; and milk

and dairy products, eggs, cereals, fruits and other vegetables also

provide small but significant amounts. As the liver of adults contains

about equal amounts of plant and animal forms of Vitamin K, it is assumed

that vitamin K is produced in the intestinal tract by bacterial flora.

One of the reasons given for the low levels of vitamin K in newborn

babies is because their gut has not yet been colonised by the required

bacteria.

Recommended daily dietary intakes of vitamin K58CategoryAgeAmount

((g)Infants0 – 110Children1 – 3154 – 6207 – 1025Adolescents11 – 143015 –

1835Adult Male19 – 70+45Adult Female19 – 70+35Pregnancy+ 10Lactating+ 20

The dietary requirements for vitamin K in infants and children are

estimates and are based on weight and growth rates as compared to adults.

Many unsupplemented breasfed infants do not show clinical signs of

vitamin K deficiency on intakes of less than 3 (g daily and the mean

requirement for infants is estimated to be 5 (g daily based on weight.

The higher amount of 10(g is recommended for prevention of Haemorrhagic

Disease of the Newborn.58

WHAT IS HAEMORRHAGIC DISEASE OF THE NEWBORN?

Haemorrhagic Disease of the Newborn (HDN) is a bleeding disorder

associated with low levels of vitamin K in newborn babies. It was first

defined in 1894 by Townsend69 as spontaneous external or internal

bleeding occurring in newborn infants not due to trauma, accident or

inherited bleeding disorders such as haemophilia. Previously, there were

no generally agreed upon criteria to determine causes of haemorrhaging,

so any diagnosis was based solely on the opinion of the attendant medical

personnel.

Infants are born with low levels of vitamin K23 compared to adults and

this is termed ‘vitamin K deficiency’. Up to 50% of babies develop this

‘vitamin K deficiency’, but bleeding occurs in only a fraction of these

cases.37 In most it starts after birth, becomes

Page 2

progressively more severe over 48-60 hours, then spontaneously corrects

itself by 72-120 hours.9

HDN has always been rare – in Britain where maternity units practised a

selective policy of vitamin K administration, the incidence was no more

than 1 in 20,000 in the years 1972-80. Estimates for late onset HDN are

4-8 per 100,000.45 Incidence also seems to vary from country to country.

HDN is divided into three categories: Early onset HDN occurs in the first

24 hours. It is very rare and mainly associated with mothers who have

taken anticonvulsant, antibiotic, antituberculous or anticoagulant drugs

during pregnancy. Classic HDN occurs in the first week after birth. It is

manifested by the oozing of blood from the intestines, the nose, the cord

site and broken skin sites. Bruising at sites where there has been no

trauma can also appear. Late onset HDN occurs after the first week, with

a peak incidence between the second and sixth weeks, and about half the

cases present with intracranial bleeding (bleeding into the brain).

WHAT ARE THE RISK FACTORS FOR HDN?

There has been some debate over the years as to whether or not HDN is

actually caused by vitamin K deficiency. Certainly, giving vitamin K does

arrest bleeding in the majority of cases, but this does not mean that

vitamin K deficiency causes HDN. One may as well say that an antibiotic

deficiency causes bacterial infection. There is also no consensus as to

what level of vitamin K in plasma protects against HDN. Some researchers

have found no evidence of vitamin K deficiency in babies in their

studies43, 49 and other factors have also been suggested.52, 73, 74

Most, if no all, of the reported cases of late onset HDN have presented

with problems which affect the baby’s ability to absorb or utilise

vitamin K.45, 56 These include: hepatitis, cystic fibrosis, chronic

diarrhoea, bile duct atresia, alpha-1-antitrypsin deficiency, coeliac

disease of insufficient plasma transport capacity. Subclinical

cytomegalovirus has also been implicated. Vitamin K-responsive bleeding

syndrome has been well documented after antibiotic therapy, especially

with cyclosporins.33

There are other factors which place the newborn at higher risk. These

include pre-term birth (as the liver is very immature), low birth weight,

instrumental or traumatic delivery, bruised or bleeding in the first few

days after birth, requiring surgery or circumcision, taking inadequate

feeds and breastfeeding.33

BREASTFEEDING – WHY IS IT A RISK?

Several authors have noted the higher incidence of HDN in solely

breastfed babies.9, 30 The incidence has been quoted as 1 in 1200.30

Studies comparing breastmilk with formula and cow’s milk have shown that

breastmilk is lower in vitamin K.22, 28, 32 Breastmilk substitutes are

heavily supplemented with vitamin K, however, it is possible that, like

iron, vitamin K is biologically more available to the baby from

breastmilk, and so such high levels are not necessary.

Measured levels of vitamin K in breastmilk seemed to vary depending on

the type of measurement used; however, they all come out lower than cow’s

milk. Fournier22 and Greer28 found levels of around 8-9(g/l, which would

mean that if a baby was taking in about 500ml per day, it would be

getting the recommended 3-5(g daily.

Vitamin K content and availability are greater in the hind milk because

of its higher fat content and vitamin K levels are also higher in

colostrum.32 As an extra plus, breastmilk contains thromboplastin, one of

the factors in blood clotting.18

Vitamin K levels in the breastmilk rise markedly in response to the

mother eating vitamin K rich foods or taking vitamin K supplements.29, 54

Nishiguchi found no cases of low vitamin K levels in breastfed infants

whose mothers had been given supplements, as opposed to infants who had

only been given 1 or 2 doses of oral vitamin K.54

Unrestricted access to the breast in the early days after birth is

important, due to the higher levels of vitamin K in colostrum. The

importance of early feeding has been recognised since the 1940’s. Babies

who have been fed within their first 24 hours have significantly better

coagulation times than babies not fed until after 24 hours.24

It is essential that, to receive the full complement of vitamin K in

breastmilk, the baby completely finishes one breast before being offered

the other. Any practice that involves restricting either the baby’s time

at the breast or the number of feeds will not allow the baby to receive

optimum amounts of vitamin K and will also prolong the time it takes for

the baby’s intestine to be colonised by friendly, vitamin K manufacturing

bacteria.

THE HISTORY OF VITAMIN K USE TO PREVENT HDN.

The search for the cause of HDN began in 1913 when Whipple82 postulated

that a lack of prothrombin activity could be a cause of HDN. In 1929,

Henrik Dam14 noticed that chicks fed a fat-free diet suffered

subcutaneous and intramuscular haemorrhages, which could be prevented if

the chicks were fed seeds, cereals and green, leafy plants. Dam described

the condition as a vitamin deficiency and named the deficient vitamin

‘vitamin K’, from the Danish word ‘koagulation’.

Research in 19378 found that prothrombin times in normal neonates were

between 30-60% adult levels, falling to 15-30% on day two, and then

gradually rising again until about day 10. This research led to the

continuing belief that these low levels in the newborn are a deficiency

and need to be corrected.

In 1939, vitamin K1 was isolated from alfalfa by Dam, for which he later

received the Nobel Prize, along with Doisy, who isolated vitamin

K2.45 Further research in 1939 by Waddell and Guerry81 found that low

plasma prothrombin levels could be elevated by the administration of oral

vitamin K.

Armed with this ‘proof’ that vitamin K deficiency caused HDN, vitamin K

was synthesised and various trials were commenced

Page 3

to ascertain which was the most effective amount and route to use in

prophylaxis.

It is difficult for us to assess these trials nowadays as they were

mostly neither double blind nor well controlled. The dosage of vitamin K

given, the route of administration and the time of administration all

varied. In many cases, the conclusions did not seem to match the

results.72

Some of the studies assessed the effect on neonatal vitamin K levels if

the mother was given vitamin K during labour.72 Results varied, with the

effectiveness of the vitamin K given depending on how soon the woman gave

birth and the dosage given. More recent studies have shown increases in

cord blood levels where mothers were supplemented antenatally with

vitamin K.1, 66 Two showed a significant difference between the

supplemented and unsupplemented groups and found that the effect of

prenatal vitamin K persisted until the fifth day after birth.1

Because of the variations in results from these early studies, further

research focussed on treating the baby after birth. One particular study

done in 194231 was intended to determine the minimal effective oral dose

of Synkavite (K3), a water-soluble synthetic form of vitamin K. The

results showed that very small daily doses were effective and that a dose

of 5(g daily would probably prevent the development of HDN, except in

early onset cases. The study also found that 1.25mg was effective in

lowering an excessively high prothrombin time to normal. However, the

author admitted that several workers found prothrombin deficiencies in

babies with no abnormal bleeding.

By 1950, most maternity units had a policy of giving infants oral vitamin

K (usually Synkavite) immediately after birth.70 This prevented the fall

in prothrombin levels that occurred in the first few days and,

presumably, the risk of excessive bleeding. This risk was higher in male

babies because of routine circumcision, and, indeed, vitamin K proved to

be of great clinical value in preventing post-circumcision bleeding.75

Then, in the mid-1950’s, reports of increased jaundice and kernicterus

(brain damage caused by high bilirubin levels) associated with vitamin K

prophylaxis began circulating. Reviews of maternity units found that some

were giving Synkavite in doses exceeding 50mg.70 It was established that

high doses of Synkavite caused haemolysis (destruction of red blood

cells) and high serum bilirubin levels.48

Researchers and medical professionals queried the safety aspects of

vitamin K, and there were many conflicting reports on the appropriate

dosages. Some researchers queried the need for vitamin K at all, quoting

results from studies that showed no difference in prothrombin times or

vitamin K plasma levels between babies that bled and babies that

didn’t.72

Eventually, a newer preparation, intramuscular vitamin K1

(phytomenadione), was developed and approved for use, solely on the

grounds that it appeared to cause less haemolysis. Phytomenadione (trade

names Konakion (Roche) or Aquamephyton (Merck, Sharpe & Dohme)) is a

synthetic petrochemical derived from 2-methyl 1,4-naptha-quinone in a

polyethoxylated castor oil base.18 In the US, polysorbate-80 is used as a

base instead of polyethoxylated castor oil.15

In spite there being no long term trials of these preparations, the

American Academy of Pediatrics recommended that phytomenadione be

administered prophylactically to all newborn babies.72 The use of oral

vitamin K preparations fell out of favour in the USA and the ‘safer’

intramuscular route became the route of choice.

In Britain, after the jaundice scare of the1950’s, many maternity units

began to practice a selective policy, giving vitamin K only to babies at

risk of haemorrhaging. McNinch reported in 1980 that less than half the

maternity units in the UK gave vitamin K to all newborns.47 Some of these

babies were given oral prophylaxis and some were given intramuscular

prophylaxis.

In Germany, almost all newborn infants who required medical care and

instrumental deliveries were given intramuscular vitamin K, and some

healthy newborns also received it.76 Records have not always been kept in

New Zealand hospitals, so it is impossible to say whether or not vitamin

K was given routinely and by which route.17

Although vitamin K use seemed to prevent most cases of HDN, there was

still controversy. Not everyone believed vitamin K deficiency was the

cause of HDN. In 1977, van Doorm et al 52, 73, 74 suggested that HDN

could be caused by a heparin-like inhibitor in the newborn and he

concluded that babies given their first feed soon after birth do not have

a vitamin K deficiency. Other researchers agreed with van Doorn.49 In

1980, Malia et al43 could find no evidence of vitamin K deficiency in

babies in their study and concluded that low levels of vitamin K

dependent clotting factors were due to the immature liver. The authors of

these studies questioned whether vitamin K prophylaxis was really

necessary for healthy newborns.

Then, starting in November 1980, there was a cluster of six cases of HDN

in Britain, all within 17 months.46 Half of these cases were classic HDN,

the other half were a new manifestation of HDN – late onset.

LATE ONSET HDN

Late onset HDN was first reported in 1977.5 It mainly occurs in breastfed

infants and ( to ¾ of cases have an underlying liver disorder or

malabsorption syndrome,15 rather than insufficient dietary intake of

vitamin K. This means the liver cannot adequately synthesise blood

clotting factors or store adequate amounts of vitamin K. Liver function

cannot be easily diagnosed at birth without a range of invasive tests and

thus there exists an unknown risk of haemorrhaging.

Many factors contribute to poor liver function, including hepatitis,

cystic fibrosis, antibiotic therapy, biliary atresia, alpha-1-antitrypsin

deficiency, a-beta-lipoproteinaemia, coeliac disease, chronic diarrhoea

and exposure to pharmacologic agents such as anticonvulsants, rifampin,

isoniazid cephalosporins and coumarin compounds33 When tested, most of

the reported cases of late onset HDN had hepatitis, liver malfunction or

enzyme

Page 4

deficiencies.6, 35, 51, 80

Birkbeck6 believes there are two processes at work – low levels of

prothrombin and vitamin K-dependent clotting factors VII, IX and X at

birth, and a further fall in these in the neonatal period. In his view

the initial low levels are not due to vitamin K deficiency as levels of 2

other non-vitamin K-dependent factors, XI and XII are also often reduced.

Thus, the situation at birth may be simply due to hepatic immaturity.

Birkbeck6 also reports that HDN is almost unknown in central Africa and

he suggests an environmental mechanism as the cause. Associated with

this, a discussion paper from the University of Amsterdam42 raises the

idea that by-products of our industrial society such as PCBs, PCDDs and

PCDFs are the cause of late onset HDN. These chemicals can induce enzymes

in the liver which cause liver damage and prolong prothrombin time.

Although overseas studies have reported contamination of breastmilk by

these pollutants, a NZ Department of Health study on breastmilk reported

that levels of these contaminants were at the lower end of the scale.7

The Health Department is currently conducting another study to see if

levels have changed over the past few years.

There seems to be a seasonal variance, with most cases of late onset HDN

occurring in the warmer months.6 It has been suggested that the mother

could have contracted a viral infection during pregnancy in the colder

months and this has crossed the placenta. Since viruses have an affinity

for the liver and mucous membranes, they can affect intestinal absorption

and liver function.67

Another suggested cause of late onset HDN includes use of the food

antioxidant BHT (butylated hydroxytoluene), which has produced vitamin K

deficiency.68 BHT is present in many processed foods, including

margarine. Our Western diets consist of a lot of processed food, and to

reduce fat intakes, margarine is recommended rather than butter. The

polyunsaturated fat in margarine is an inhibitor of vitamin K

absorption.68 Both of these factors could have an effect on the amount of

vitamin K available to pass through to the baby. A high level of vitamin

K in the mother’s blood is necessary to ensure adequate transplacental

transfer of vitamin K.9, 33 It is important for the baby to have adequate

stores of vitamin K in its liver at birth to prevent bleeding until its

feeding and gut flora are established.

Of the six cases of HDN in Britain in 1980-1982, all were breastfed and

none had received vitamin K at birth.46 Two of the cases were in the

high-risk group – one was born by caesarean section and had an epileptic

mother treated with phenytoin, and the other had an alcoholic mother who

had taken anti-depressants – and obviously should have received vitamin K

at birth.

These cases prompted a call for the re-introduction of routine

prophylaxis. Many opposed the idea of unnecessarily injecting otherwise

healthy babies so studies40, 47, 55, 79 were therefore conducted to

determine whether oral vitamin K was as effective as intramuscular. It

was also proposed that oral vitamin K would be more cost-effective and

thus better suited for use in Third World countries.55 Results of these

studies varied. Some showed that oral vitamin K was effective in

preventing classic haemorrhagic disease but not as effective as

intramuscular vitamin K in preventing late onset HDN.47, 55, 78 Others

found oral as effective, especially a 10 year study conducted on 38,000

infants in Sweden where no cases of HDN were observed over that period.40

Tripp and McNinch reported no cases in 25,000 babies in their maternity

unit where only those at risk were given intramuscular prophylaxis and

the rest oral prophylaxis.70

In spite of these findings that oral vitamin K prophylaxis was not

effective in preventing late onset HDN, it continued to be used in

British maternity units, especially for low risk infants.

RISKS OF VITAMIN K PROPHYLAXIS

Konakion ampoules contain phenol, propylene glycol38 and polyethoxylated

castor oil as a non-ionic surfactant. Studies in animals given

polyethoxylated castor oil have shown a severe anaphylactic reaction

associated with histamine release. Strong circumstantial evidence

implicates polyethoxylated castor oil in similar reactions in humans.

Polyethoxylated castor oil, when given to patients over a period of

several days, can also produce abnormal lipoprotein electrophoretic

patterns, alterations in blood viscosity and erythrocyte aggregation (red

blood cell clumping). Individuals sensitive to this base are

contraindicated from using Konakion. New Ethicals Compendium also warns

that the use of Konakion can cause jaundice and kernicterus in infants.53

Other listed side effects include flushing, sweating, cyanosis, a sense

of chest constriction, and peripheral vascular collapse. Local cutaneous

and subcutaneous changes may occur in areas of repeated intramuscular

injections.

This synthetic, injectable vitamin K formulation was never subjected to a

randomised, controlled trial. In new drugs that are to be used for

prophylaxis, the usual risk/benefit analysis does not apply, since the

individual is not ill. The ethical principle of non-maleficence (primum

non nocere – first do no harm) applies and the trials must thus be larger

in order to identify any previously unrecognised side effects.65 Since

this did not happen, nor was there any long term follow up, we actually

have little idea of the effects of this drug on newborn babies.

The risks of injecting vitamin K into a newborn baby are nerve or muscle

damage as the preparation must be injected deeply into the muscle, not

subcutaneously under the skin. There is also the documented risk of

injecting the baby with the syntocinon intended for the mother.30, 70 As

stated in the product information,53 infants can suffer from jaundice or

kernicterus (brain damage from a build-up of bile pigments in the brain)

from Konakion. Infants who have the enzyme deficiency G6PD (glucose 6

phosphate dehydrogenase) are at particular risk from vitamin K.30 The

other risk factor is the possible increased chance of childhood cancer.

THE LINK BETWEEN CHILDHOOD CANCER AND INTRAMUSCULAR VITAMIN K

In 1970, a national cohort study of 16,193 infants born in one week in

April was begun in Britain.26 This study was to test

Page 5

hypotheses about childhood cancers and their associated factors.

Thirty-three of the children had developed cancer by age 10 and were

compared with 99 control children, matched on maternal age, parity and

social class. One of the unlooked-for risk factors was the administration

of prophylactic drugssuch as vitamin K in the first week after birth – a

nearly three-fold risk. This association fitted no prior hypothesis and

the authors recommended that their finding be tested in another series of

cases.

The authors of the study approached Roche, the manufacturers of Konakion,

for funding for a further trial to examine the findings more closely.

Roche was not interested until, a few months later, the media reported

the results of the study and that vitamin K given to babies might cause

childhood cancer. Roche then decided to fund a new study.27

The new study25 was a case-control study of 195 children with cancer born

at either of two hospitals in Bristol, England, compared with 588 healthy

children also born at these hospitals. One hospital predominantly gave

vitamin K orally and the other intramuscularly. The authors found a

nearly two-fold risk of leukaemia in children who had received

intramuscular vitamin K.

These findings were extremely worrying. Golding calculated that the extra

cases of leukaemia caused by vitamin K injection could be as many as 980

in the UK alone.25 These results were supported by reports of the

potential carcinogenicity of vitamin K from Israels et al, who suggested

that low vitamin K levels in the newborn protect against the risk of

mutations during a period of rapid cell growth and division.39 Pizer et

al did not find any association between the route of vitamin K

administration and mutations in cells but concluded that his study was

too small to show any real effect.62 Another study reported no increase

in abnormalities in newborn infants, but, with only 12 infants, the study

was too small to show any real effect.10 It is worth noting that after an

intramuscular dose of vitamin K, the baby’s plasma levels are almost 9000

times the normal adult levels.47 It has also been suggested that the

cancer-causing agent could be a metabolite, N-epoxide, or some other

component of the solution other than vitamin K itself.15

Golding’s study was criticised by many. One of the reasons was that the

authors had to make assumptions for some cases, as the information on

vitamin K administration was not clearly recorded. In spite of this,

expert epidemiologists considered that the results were plausible and so

could not be lightly dismissed.15 Further studies were proposed to answer

the question of cancer and vitamin K.

In 1993, results from three retrospective studies on vitamin K and

childhood cancer were published. The studies were done in the USA,

Denmark and Sweden.41, 57, 19 These studies, although large, did not

confirm the association between intramuscular vitamin K and childhood

cancer. One of the studies not only showed no association between IM

vitamin K and childhood cancer, it also showed no association between

maternal smoking and childhood cancer, a finding totally at odds with the

results from many other studies.19 The other two studies were also not

comparable to the British study. One because of differences in type of

vitamin K given41 and the other because of the use of birth cohorts with

differing regimens of vitamin K usage.57

Because of the design flaws in these studies, there was still a need for

further case-control studies. Results from two were published in 1996.2,

77 They had carefully matched controls and more accurate information on

whether vitamin K had been given or not, and by which route. One of the

studies2 reported no association between intramuscular vitamin K and

childhood cancer and the other77 found a risk of leukaemia, but only when

cases were compared with local controls (i.e. from the same hospital) and

not with controls randomly selected from the whole area under study.

This, although suggestive, was not followed up but dismissed as a chance

finding related to multiple testing.

The suggestion was then put forward that, as these studies had failed to

show a definite association between intramuscular vitamin K and childhood

cancers, worries about any potential cancer risk should be abandoned.83

At that time, four more studies on vitamin K and cancer were in

progress.44, 59, 60, 61 The results from these four studies were

published in 1998. Two of them failed to confirm any increased risk of

childhood cancers.44 61 One of the other studies showed a twofold risk of

acute lymphoblastic leukaemia among 1-6 year olds,59 the other showed a

significant risk for all cancers.60

So, the jury is still out on whether there is an increased risk of

childhood leukaemia with the intramuscular form of vitamin K. Some

recommend that intramuscular vitamin K should still be used, as the risk

of leukaemia “seems more hypothetical than real”.76 Others believe that

public confidence in IM vitamin K has been severely shaken and will be

difficult to restore fully. They recommend an oral regimen similar to

that used in the Netherlands of 25(g daily, given by the mother. This

would avoid the grossly unphysiological peaks of vitamin K from both the

IM route and the present oral route.71

ORAL VITAMIN K VS INTRAMUSCULAR

The two main problems with giving vitamin K orally are that there is no

licensed oral formulation, meaning that babies receive the intramuscular

form orally, and that compliance with three oral doses is poor as many

doctors and midwives are reluctant to give an unlicensed formula.13 The

use of unlicensed preparations may theoretically expose professionals to

litigation in the event of prophylactic failure or unforeseen adverse

events.2

Roche, the manufacturers of Konakion, state that they do not recommend

the administration of Konakion solution orally.63 Their reasons are: that

they have no clinical studies to support oral use, phenol, which has been

reported to be an irritant to newborns mouths, is used as a preservative,

the variability in the production of bile salts in newborns may affect

absorption, that Konakion given orally has a small association with

anaphylactic reactions.

Page 6

The preparation was also unpleasant to taste and babies were inclined to

spit it out82 or to vomit it back up. Only about half of an orally

administered dose is absorbed.47 Even so, the plasma concentrations in

babies who were given oral vitamin K reached 300 times the adult levels,

before dropping off slightly after about 24 hours.47

After the publication of Golding’s studies, further trials were done on

oral vitamin K prophylaxis and whether it gave longer term protection. In

1992, Cornelissen11 found plasma vitamin K concentrations were higher in

the group given IM vitamin K than the oral group, but blood

coagulability, activities of factors VII, X and PIVKA-II concentrations

showed no differences. By 3 months follow-up, vitamin K levels had

dropped in both groups but more in the oral group. He suggests that

neither give long term protection. One would assume that babies should be

producing their own vitamin K by 3 months and, if not, what other

mechanism could be hindering this process.

Von Kries et al78 studied repeated oral vitamin K prophylaxis in Germany,

with 3x 1 mg doses and found that it was not as effective as a 1mg

intramuscular dose at birth. Another study by Cornelissen et al12

reported on the effectiveness of differing regimens of oral vitamin K in

four different countries – the Netherlands, Germany, Switzerland and

Australia (two differing regimes). In the Netherlands, babies are given

25 (g daily oral vitamin K for 3 months with I mg given at birth either

orally for healthy newborns or intramuscularly for unwell babies. In

Germany, the regime is 3 x 1 mg oral doses as was also the case in

Australia from 1993 to 1994. In Switzerland 2 oral doses of a new

‘mixed-micellar’ oral vitamin K is given. The Netherlands had the lowest

failure rate – 0 per 100,000. In Australia, where the regime was changed

in 1994 from oral to IM, the failure rate was 1.5 per 100,000 for oral

and 0.9 per 100,000 for IM, showing that 3 oral doses are less effective

at preventing late onset HDN than one IM dose of vitamin K. Even if Roche

are persuaded to bring the mixed-micellar preparation into New Zealand,

results from Switzerland (failure rate of 1.2 per 100,000)12 show that

further study needs to be done on the most effective timing of the doses.

If New Zealand parents wish their baby to receive oral vitamin K, the

recommended regimen is for 3 x 1mg doses, 1 at birth, 1 at 5 days and 1

at 6 weeks.6, 20 It is up to parents to ensure that their baby receives

all 3 doses if they choose this form of prophylaxis.

CONCLUSION

It would seem an anachronism that babies are born with a deficiency of

such an essential vitamin and require supplementation. In fact, although

there have been many studies on differing aspects of vitamin K

prophylaxis, there has only been one39 on the possible reasons for and

the advantages (if any) of the physiological levels of vitamin K in

newborns.

The risks of prophylaxis for the majority of babies who are at low risk

of HDN are also not understood. As plasma vitamin K levels in newborns

reach 300 times normal adult levels for oral and almost 9000 times for IM

vitamin K47, some research needs to be done on the effects this may have.

Studies have shown that physiological levels of vitamin K maintain a

careful balance between coagulation and anti-coagulation and we have no

idea what the effects of upsetting that delicate balance would be.

The number of children currently developing cancer during childhood is

much higher than the number developing a life threatening or permanently

disabling problem as a result of late onset HDN. The risk of childhood

cancer is estimated to be 1.4 per 1000, from the 1970 British cohort. If

IM vitamin K caused cancer, there would be 100 extra cases of cancer per

case of HDN prevented.16 This could mean that giving IM vitamin K to

every baby would be doing more harm than good.36

The decision rests on parents’ shoulders – the link between intramuscular

vitamin K and childhood cancer has not been definitively proved, nor has

it been completely disproved. It may be that an oral regimen as suggested

by Tripp and McNinch71 could be the answer to the dilemma. If this is the

case, then Roche needs to be lobbied to make the European preparations

available in New Zealand. In the meantime, the choice is between no

vitamin K, with the mother being aware of her dietary intake of vitamin

K, an oral regimen or the intramuscular formulation.

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--------------------------------------------------------

Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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