openFDA
Cure8 regulatory brief
Why This Matters
People with IBD (ulcerative colitis or Crohn’s/regional enteritis) may develop vitamin K–related hypoprothrombinemia; this updated label describes when and how vitamin K (phytonadione) is used and emphasizes INR monitoring and safety considerations.
It also warns about serious allergic reactions with injectable vitamin K.
Who Should Pay Attention
Adult patients with IBD, clinicians who manage anticoagulation and bleeding in IBD or malabsorption, and pharmacists.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This label update describes approved uses of phytonadione—to treat hypoprothrombinemia due to vitamin K deficiency or interference—and gives dosing ranges for adults, notes that effects on INR can take 1–8 hours, and recommends checking prothrombin time/INR to guide dosing.
The label cautions that oral absorption may be impaired when bile salts are lacking (bile-salt replacement may be needed), that phytonadione won’t reverse heparin, and that severe hypersensitivity reactions have been reported with parenteral administration.
If phytonadione is given to reverse excess anticoagulation, clinicians should be aware that restoring vitamin K–dependent clotting factors can return patients to a prothrombotic baseline; dosing should be as low as clinically effective and INR should guide repeat dosing.
Keep In Mind
This is a regulatory drug-label record (DailyMed/FDA). It provides prescribing information but is not clinical guidance for individual care; dosing and route should be determined by a treating clinician. The label notes that oral absorption can be impaired when bile flow is deficient and that prothrombin time/INR should guide therapy.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Evidence type derived from source or registry metadata.
PublicationopenFDA
PublisherU.S. Food and Drug Administration
SponsorSafecor Health, LLC
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedSep 2, 2026, 12:00 AM
Content availableRegulatory record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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