Lozada Y1, Falcone M, Granero R.Author information1Asociación Cardiovascular Centro Occidental (ASCARDIO), Barquisimeto, Estado Lara, Venezuela.AbstractAnticoagulation therapy with warfarin, a common clinical practice, needs to be monitored using protombine time expressed as the International Normalized Ratio (INR); when safety range is exceeded, Vitamin K (Vit-K) could be administered with preference orally. In Venezuela the specific oral preparation for Vit-K is not available. This is a double blinded, randomized, placebo controlled, clinical trial; 20 patients, age 18-60 year with initial INR ≥ 6, ≤ 10, were randomized to oral Vit-K 1.25mg (prepared from intravenous presentation) or placebo plus withholding warfarin. INR < 3.5 at 24 hours of treatment (the primary end point) was achieved by 70% among Vit-K, and 20% among placebo patients; given an absolute risk reduction (ARR), of 50% (CI95%: 14.4-85.6) p = 0.028, NNT 2 (CI95%: 1.3 - 6.9). No adverse events were recorded including INR < 2 at 24 hours of treatment administration.
Our results are consistent with studies where specific oral presentation of Vit-K was used. The results indicate that oral administration of Vit-K, prepared from an intravenous Vit-K preparation, is safe and more effective to revert excessive anticoagulation than simply withholding warfarin, in places where specific preparation of oral Vit-K is not available or too expensive.PMID: 22522851 [Indexed for MEDLINE] Publication typesEnglish AbstractRandomized Controlled TrialMeSH termsAdministration, OralAdultAnticoagulants/adverse effects*Blood Coagulation/drug effectsCoagulants/administration & dosage*Double-Blind MethodFemaleHumansInternational Normalized Ratio/standards*MaleMiddle AgedProthrombin TimeThromboembolism/prevention & controlVitamin K/administration & dosage*Warfarin/adverse effects*Young AdultSubstancesAnticoagulantsCoagulantsVitamin KWarfarinFull Text SourcesFundacion Revista Medicina (Buenos Aires) - PDFMedicalBlood Thinners - MedlinePlus Health InformationVitamin K - MedlinePlus Health InformationMiscellaneousWARFARIN - Hazardous Substances Data Bank
This article covers:Background of vitamin K after birthAre some babies at higher risk of HDN?What are the effects of giving vitamin K by injection?What are the effects of giving vitamin K orally?Why were breastfed babies thought to be at increased risk?Should women take vitamin K?Possible vitamin K deficiency symptoms to watch out for In the UK, parents of new babies are routinely asked if their baby is to have supplementary vitamin K by injection or oral supplement, which is needed to make blood clot and prevent excessive internal bleeding. Compared with adults, newborn babies are born with low levels of vitamin K but the amount is normally sufficient to prevent problems. Some babies are at risk, however, because they don’t have sufficient vitamin K, and they have an increased risk of Haemorrhagic Disease of the Newborn (HDN), also known as Vitamin K Deficiency Bleeding (VKDB). While some babies are at a higher risk than others (see below), some babies who are at risk of bleeding don’t show any risk factors and, for this reason, the Department of Health recommends all babies are given vitamin K soon after birth, usually by injection.
However, it is your choice as a parent to decline, if you wish; you can also opt for vitamin K to be given by mouth instead. HDN is a rare but very serious disease. Half of all babies who have HDN have a haemorrhage into their brain (intracranial bleeding). This often causes brain damage, and the baby may die. In the 1950s and 1960s, it became standard practice for all babies to have an injection of vitamin K into a muscle. Later, in the 1980s, some health professionals and parents wondered if it was necessary to give vitamin K injections to every newborn baby. Instead, single doses by mouth became popular, and some babies, if they were not deemed to be at higher risk, were not given the supplement at all. A UK study published in 1991 confirmed that HDN was rare. The babies who had HDN were more likely to have liver disease or be breastfed. Then, in 1990 and 1992, studies were published that suggested a possible link between injected vitamin K and childhood cancers including leukaemia.
This meant more babies were given vitamin K by mouth. The number of babies with HDN went up slightly as a result, perhaps because oral vitamin K is slightly less effective than when it is given by injection. Since then, further studies have failed to find any link between injected vitamin K and childhood cancers of any type and, in 1997 an expert body for the UK Department of Health concluded that this was no longer a concern. Babies at increased risk of HDN include: This means that about a third of babies are at increased risk. Some studies suggest that many of the babies who develop bleeding have unseen problems with their liver. It is hard to spot these babies before they bleed, so vitamin K can be preventive. Giving vitamin K by injection probably keeps levels higher for longer, compared with vitamin K by mouth, as it remains stored in the muscle where it was injected. Problems from the injection are very uncommon but may happen, as with any injection. Babies can feel pain and, on rare occasions, may have an infection at the place where the injection goes in, or bleeding and bruising in the muscle.
Mistakes are very occasionally made with the injection, and the wrong dose or drug may be given. Oral vitamin K is given in three separate doses, over the first month of life. Studies have shown that sometimes, a dose is omitted, probably because it’s forgotten about, and this means full protection is not given. According to studies, HDN was more common among breastfed babies. We know vitamin K levels are higher in colostrum (the first milk you produce) than in mature milk. In the past, babies were not breastfed till some time after birth, and strict feeding routines were usual; this probably meant that babies got less vitamin K than nature intended. Nowadays, babies are usually breastfeed soon after birth, and they feed frequently for as long and as often as they want. This means they get more colostrum than they used to, reducing the risk of HDN. Formula milk has vitamin K added to it. Giving vitamin K to mums before and after they have their babies has been tried in small-scale studies.