All newborns are offered a synthetic form of vitamin K within the first few hours after birth as prophylaxis against VKDB. The brand name is Konakion and is manufactured by CHEPLAPHARM. Konakion is a vitamin injection, not a vaccine. The HSE provides two administration options:

• Oral Doses: first dose is given soon after birth, followed by a second dose between days 4-7, and a third dose at one month, which requires a doctor’s prescription for parents to pick up from the pharmacy. Formula-fed babies do not need the third dose, as formula contains added Vitamin K.
• Injection: a single intramuscular shot shortly after birth.

This article provides an overview of the potential risks associated with both the injection and the disease it targets, helping you make an informed decision.

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Disease versus Injection Risk Summary

Risk from Vitamin K Deficiency Bleeding
Risk of baby getting VKDB Approx 1 in 10,000 (0.01%): (6-7 cases per year) Risk of baby getting brain damage Approx 1 in 33,000 (0.003%): (2 cases per year) Risk of baby dying from VKDB in Ireland Approx 1 in 143,000 (0.0007%): (less than 1 baby every two years)

Risks from vitamin K vaccine (Konakion)
1 dose injection or 2 to 3 oral doses for newborns (as per drugs.com side effects for phytomenadione)

Observed side effects post administration of phytomenadione (post marketing)
Cardiovascular: tachycardia, flushing Hypersensitivity: fatal hypersensitivity reaction Other: death (intravenous IV and intramuscular IM routes) Nervous system: dizziness, dysgeusia (taste disorder)

Frequency not reported

Jaundice, hemolysis, erythema perstans-like lesions, bluish colour of the fingernails, lips, skin, palms, or nail beds Blurred vision, chest tightness, confusion, cough, difficulty swallowing, dizziness, faintness, or lightheadedness when getting up suddenly Fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue Rapid and weak pulse, sweating, trouble breathing, unusual tiredness or weakness, yellow eyes or skin

Risk Category	Observed Side Effects
< 1 in 10,000 (0.01%)	Cardiovascular: Facial flushing Hypersensitivity: Anaphylactoid reactions (IV route) Nervous system: unusual taste
< 1 in 1,000 (0.1%)	Cardiovascular: Rapid and weak pulse, hypotension, cyanosis Respiratory: dyspnea Dermatological: profuse sweating, scleroderma-like lesions Nervous system: dizziness Hepatic: hyperbilirubinemia

WHO Vigiaaccess Adverse Events Reporting System As of Nov 2024, 10,863 adverse events have been reported for vitamin K.

Note: The study, characterising the severe reactions of parenteral Vitamin K1 outlines an incidence rate of 3 in 10,000 (0.03%).

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What is Vitamin K and VKDB Disease?

Vitamin K is a fat-soluble vitamin stored in the liver and fat tissue, essential for blood clotting and bone health. It is present in leafy green vegetables, butter and some other foods, however, does not cross the placenta. Newborns naturally have low vitamin K levels, which may allow stem cells in cord blood to better reach areas needing repair after birth, suggesting a benefit to delayed cord clamping. Colostrum, the nutrient-rich fluid produced by the mother soon after birth, also provides more vitamin K than mature breast milk supporting the baby in the first few days.

Vitamin K Deficiency Bleeding (VKDB) can arise if babies become deficient in vitamin K and can lead to internal bleeding. VKDB comes in three forms:

• Early-onset VKDB: Occurs within the first 24 hours, mostly in babies whose mothers were on certain medications during pregnancy. Prenatal vitamin K supplementation has not been shown to reduce early-onset VKDB
• Classical VKDB: Typically appears between days 2 and 7. This is the most common form and is more likely to affect babies who are premature, had a complicated delivery e.g. forceps delivery, have been circumcised or are compromised in other ways.
• Late VKDB: occurs between 2 weeks and 6 months and is the most dangerous form. It can be associated with liver disease. Vitamin K at birth may not prevent late VKDB in such cases and can sometimes mask liver disease.

What is the risk of getting VKDB?

Assessing the risk of Vitamin K Deficiency Bleeding (VKDB) in newborns who don’t receive Vitamin K is difficult because supplementation has been standard practice before effective measurement methods were developed. Using public health agency estimates on babies’ VKDB risk (see below), a summary of the risk of VKDB without receiving vitamin K prophylaxis (Konakion) works out as follows:

Does Konakion guarantee protection from VKDB?

No babies can still get VKBD even if they have received Konakion.

Additional safety data for Konakion

Like all medicines, Konakion comes with side effects. Parents need to do their research and ensure the benefits outweigh the risks.

• See Disease Vs Vaccine Risk table at the top of this page for list of possible side effects from Konakion
• A boxed warning exists with intravenous and intramuscular administration of Phytomenadione (synthetic vitamin K) due to the possibility of severe reactions, including fatalities. According to this study, it occurs at incidence rate of 3 per 10,000 doses of intravenous vitamin K1.
• Konakion contains lecithin. It does not specify where the lecithin is derived from or whether it has been derived from source that has been genetically modified.
• As of Nov 2024, 10,863 adverse events have been reported on the World Health Organisation Vigiaccess for vitamin k injections including Konakion.

What are the ingredients of Konakion?

Vaccine	Ingredients as listed on patient information leaflet
Konakion Vitamin K	Active substances: synthetic vitamin K phytomenadione Other ingredients: glycocholic acid, [popup_anything id=”4794″], lecithin, [popup_anything id=”4793″]