Have a High Threshold for Administering Vitamin K Intravenously
Michael J. Moritz MD
Anaphylactoid reactions in patients receiving intravenously (IV) administered vitamin K have been widely reported. A recent review of the literature along with the US Food and Drug Administration (FDA) adverse drug reaction database uncovered a total of 155 cases, 27 of which were fatal and with the true number no doubt being much higher. The manufacturer has sufficient concern over the safety of IV administration of vitamin K that it was voluntarily removed from the Canadian market. Anaphylactic reactions and fatalities have occurred even when IV vitamin K was given at low doses and by slow dilute infusion. Of the reported 155 cases, 21 cases with four fatalities occurred in patients who received doses smaller than 5 mg of IV vitamin K. Reactions in patients receiving vitamin K by a non-IV route do occur but are much less common.
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The pathogenesis of this reaction is unknown and may be due to vasodilatation related to the solubilizing vehicle or immune-mediated (i.e., allergic) processes. The solubilizing agent is polyethoxylated castor oil (Cremophor EL). Despite rumors to the contrary, there has been no change in the formulation of the solubilizing agent in the last several years that decreases the risk of IV use. Other drugs using this agent include paclitaxel, cyclosporine, and teniposide, and all three drugs, when administered by IV, have been associated with reactions including anaphylaxis. The incidence of anaphylaxis after IV vitamin K appears to be similar to that of other drugs known to cause anaphylaxis, such as penicillin or iron dextran.