Vitamin K package insert - Mothering Forums

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#1 of 8 Old 02-01-2009, 01:26 AM - Thread Starter
 
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Hi, I was hoping some of you could help me out with this. Someone posted this package insert on another thread: http://www.fda.gov/medwatch/SAFETY/2...EPHYTON_PI.pdf

It starts with a warning which states, in part:

Quote:
...Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration....Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.
But then it goes on to say:

Quote:
The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn. A single intramuscular dose of AquaMEPHYTON 0.5 to 1 mg within one hour of birth is recommended.
(bolding mine)

So intramuscular injection could cause severe reactions, including death, and should be restricted to cases where "the serious risk involved is considered justified"....yet every newborn should get an intramuscular injection as a prophylactic?? Am I understanding this correctly?

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#2 of 8 Old 02-01-2009, 02:19 AM
 
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read the FULL warning-- the IM reactions including death are related to hypersensitivity or anaphylaxis- brand new neonates don't have anaphylaxis - vitamin K is given to more than just neonates which is why the info is in the package insert

so I did a lit search and for IM here is the case report I could find--
Acta Obstet Gynecol Scand. 1989;68(4):381-2.

Severe complication to phytomenadione after intramuscular injection in woman in labor. Case report and review of literature.
Anderson TH, Hindsholm KB, Fallingborg J.
Department of Respiratory Medicine, Aalborg Hospital South, Denmark.
A 28-year-old woman in labor developed a severe anaphylactoid reaction,
necessitating acute cesarean section, with subsequent neonatal death, after
receiving 10 mg of phytomenadione (Konakion) by the intramuscular route.
Allergologic investigations revealed no type I reaction against the drug, and the symptoms were considered to be caused by drug-induced intolerance. Prophylactic administration of phytomenadione to the infant rather than to the parturient is recommended.

PMID: 2618627 [PubMed - indexed for MEDLINE]
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#3 of 8 Old 02-02-2009, 10:36 PM - Thread Starter
 
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Oh I didn't know newborns don't have anaphylaxis....why is that? Although it does say, "Typically these severe reactions have resembled hypersensitivity or anaphylaxis....." so I wonder if the reactions sometimes aren't anaphylaxis.

Does anyone know if there is any risk of death or serious injury from the vitamin K shot? I've read that jaundice is one potential side effect of the shot; are there any others?

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#4 of 8 Old 02-02-2009, 11:02 PM
 
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so why they don't has to do with the type of immune exposure that goes on prenatally -- IgG but other stuff isn't passed on so easy--- that is the thing- I have done the research and there was a meta study that showed that it may have been associated with childhood lukemia but followup huge studies could not find a correlation -- the areas of the UK where the initial studies were done are also mining areas, and or smelter-- and here in the US there is a connection between mining of or smeltering tungston(that light filiment stuff)so that may ultimately be the true cause. so the typical possibilities of injection site infection... stuff like that but the bigger death rate and sickness rate is on the side of not using some type of vitamin K and breastfeeding your infant---
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#5 of 8 Old 02-02-2009, 11:11 PM - Thread Starter
 
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Originally Posted by mwherbs View Post
but the bigger death rate and sickness rate is on the side of not using some type of vitamin K and breastfeeding your infant---
What do you mean by "bigger death rate and sickness rate"? Are you referring to babies who get the vit K shot?

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#6 of 8 Old 02-02-2009, 11:19 PM
 
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the bigger death and illness rate is when babies do not get oral or shot form of vitamin K and are breastfed
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Pharmacoepidemiol Drug Saf. 1998 May;7(3):173-82.

Adverse events associated with vitamin K1: results of a worldwide postmarketing surveillance programme.
Pereira SP, Williams R.
Gastroenterology Unit, Guy's Hospital, United Medical & Dental Schools of Guy's and St Thomas' Hospitals, London, UK. s.pereira@umds.ac.uk

We compared adverse events associated with a conventional vitamin K(1)preparation, Konakion, with a new mixed micellar formulation, Konakion MM. Data were obtained worldwide from spontaneous reports, clinical trials and postmarketing surveillance. During the period 1974 to July 1995, an estimated 635 million adults and 728 million children were prescribed Konakion or Konakion MM. Of the 404 adverse events in 286 subjects reported, 387 (96%) were associated with Konakion. Konakion MM accounted for 4% (n=17) of the reported adverse events, and 5% of total sales figures. Thirteen of the 17 adverse events (76%) reported for Konakion MM were minor injection site reactions. Overall, 120 of the adverse events were serious, of which 117 (98%) were associated with Konakion.
Eighty-five probable anaphylactoid reactions (of which six were fatal) were reported for conventional Konakion, compared with one non-fatal anaphylactoid reaction for Konakion MM. During the last 12 months of postmarketing surveillance, there were 14 serious adverse events reported in an estimated 21 million individuals treated with Konakion, but none in the 13 million who received Konakion MM. These results suggest that the Cremophor EL-solubilized preparations of vitamin K(1) have a higher profile of adverse events, including anaphylactoid reactions, than the newer mixed micellar preparation, Konakion MM.
Copyright 1998 John Wiley & Sons, Ltd.


PMID: 15073995 [PubMed]
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#7 of 8 Old 02-11-2009, 02:20 PM
 
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Quote:
Originally Posted by liliaceae View Post

Does anyone know if there is any risk of death or serious injury from the vitamin K shot? I've read that jaundice is one potential side effect of the shot; are there any others?
there are studies linking it to leukemia. and the ped in hospital gave me papers stating that while trying to convince me to let them give it. :eyeroll:
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#8 of 8 Old 02-11-2009, 06:46 PM
 
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there was one meta study in the area of the UK where they do mining and processing- in other areas of the world where there is this type of mining or metal processing there are other leukemia clusters which would be my guess as to why the leukemia clusters were found. when there was a closer examination and other huge studies on injectable vitamin K in other areas they could find no link with leukemia. --
over all there is a distinct lack of adequate vitamin K in our diets
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