New Food and Drug Administration requirements for inclusion of vitamin K in adult parenteral multivitamins

Abstract

The newly amended requirements by the Food and Drug Administration (FDA) for an effective adult parenteral multivitamin drug product increase the amounts of vitamins B1, B6, C, and folic acid currently in the product to better meet estimated needs, and specifies the inclusion of 150 microg of vitamin K. Infuvite Adult Multiple Vitamins for Infusion is the first adult parenteral multivitamin product to meet the revised FDA requirements. The inclusion of vitamin K in adult parenteral multivitamin products is intended to afford patients a consistent daily supply of vitamin K approximating usual levels of intake. This is a change to clinical practice in the United States, where vitamin K has not been included in adult parenteral vitamin preparations, and physicians prescribe vitamin K separately. The reformulation of adult parenteral multivitamins required by the FDA raises questions about the potential impact that inclusion of vitamin K will have on patient management. One clinical practice change is that patients on parenteral nutrition receiving Infuvite Adult should no longer need weekly subcutaneous (SC) or intramuscular (IM) vitamin K injections. In addition, the consistent and modest level of vitamin K provided by the reformulated adult parenteral multivitamins may make it easier for physicians to maintain the desired level of hypoprothrombinemia (low levels of prothrombin) in those patients also on anticoagulant therapy with warfarin. However, for physicians accustomed to administering vitamin K separately, it is important to highlight that it may be more difficult to titrate anticoagulant therapy, especially among patients receiving dual feeding or vitamin K from another source. If marketed globally, these clinical practice issues may be more pronounced outside of the United States, where dual feeding is common, and patients may receive vitamin K from other sources.

In April, 2000, the FDA recently revised their adult parenteral vitamin requirements, increasing the amounts of vitamins B₁, B₆, C, and folic acid, and adding 150 μg of vitamin K. Infuvite Adult Multiple Vitamins for Infusion is the first adult parenteral vitamin preparation reformulated to meet the revised FDA requirements. The inclusion of vitamin K in a parenteral multivitamin preparation raises several clinical practice questions but is consistent with maintaining hypoprothrombinemia in patients receiving therapy with coumarin anticoagulants.