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Oral Versus Intramuscular Phytomenadione

Safety and Efficacy Compared

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Abstract

Oral and intramuscular Phytomenadione (vitamin K1) prophylaxis became an issue following the report of a potential carcinogenic effect of intramuscular but not oral Phytomenadione prophylaxis. There is increasing evidence, however, that oral Phytomenadione prophylaxis is less effective for the prevention of late vitamin K deficiency bleeding (VKDB) than intramuscular prophylaxis.

Following a report of an increased cancer risk after intramuscular phytomenadione, a series of papers on this issue appeared. Although an increased risk for solid tumours could almost certainly be excluded, a potential risk for acute lymphatic leukaemia in childhood could not be ruled out definitively.

Almost all cases of late VKDB are preventable with intramuscular phytomenadione prophylaxis administered once at birth, whereas a single oral dose given at birth is much less effective. Repeated oral Phytomenadione doses given to breast-fed infants either weekly (1mg) or daily (25μg) seem to be as effective as intramuscular Phytomenadione prophylaxis. The efficacy of 3 oral 2mg doses with the new mixed micellar preparation (‘Konakion MM’) remains to be established.

Although a number of studies have failed to confirm a cancer risk with phytomenadione, these studies have been unable to rule out a risk definitely because absence of evidence is not evidence of absence. A meta-analysis of the available studies might provide 95% confidence intervals narrow enough to exclude even a small cancer risk with some certainty. Oral prophylaxis will probably be as safe as the intramuscular prophylaxis if given daily (25μg) or weekly (1mg).

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Authors and Affiliations

  1. Department of Epidemiology, Institute for Social Pediatrics and Adolescent Medicine, Ludwig-Maximilians-Universität München, Heiglhofstrasse 63, D-81377, München, Germany

    Rüdiger von Kries

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  1. Rüdiger von Kries
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Correspondence to Rüdiger von Kries.

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von Kries, R. Oral Versus Intramuscular Phytomenadione. Drug-Safety 21, 1–6 (1999). https://doi.org/10.2165/00002018-199921010-00001

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