openFDA
Cure8 regulatory brief
IBD medication FDA label update (2026-07-15)
Medications
Regulatory Update
Clinicians
Patients On Biologics
Adult patients
Ulcerative colitis
Inflammatory bowel disease
Why This Matters
This FDA drug label explains when vitamin K (phytonadione) is indicated and how it should be dosed and monitored. People with IBD can develop vitamin K–related clotting problems because of malabsorption; the label clarifies use and safety considerations relevant to that situation.
Who Should Pay Attention
Patients with inflammatory bowel disease (Crohn’s disease or ulcerative colitis), clinicians managing bleeding or anticoagulation, and caregivers of people at risk for vitamin K deficiency.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Source depthRegulatory record
What To Know
This DailyMed record is a U.S. FDA drug label (regulatory record) for phytonadione (vitamin K1).
The label lists indications, dosing guidance, and safety information including that hypoprothrombinemia can occur secondary to conditions that impair vitamin K absorption such as ulcerative colitis, regional enteritis (Crohn’s disease), intestinal resection, and celiac disease.
It includes dosing ranges, monitoring guidance (prothrombin time/INR), and warnings about parenteral administration-related hypersensitivity. The document is a label update/regulatory record and describes the drug’s approved uses and important safety and administration instructions.
It is not a clinical-trial report or patient-facing guidance document; it serves as the official product information clinicians use for prescribing and monitoring.
If you or a caregiver are using anticoagulants or have an IBD-related risk for vitamin K deficiency, this label explains when phytonadione may be used and emphasizes checking prothrombin time/INR and considering alternate therapies or supportive blood products when rapid correction is needed.
Keep In Mind
This is the official prescribing information (drug label) intended for clinicians and pharmacists. It reflects regulatory-approved indications and safety language rather than new clinical research. For individual treatment decisions, talk with your clinician.
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
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedJul 15, 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.
PredniSONE FDA label update (2026-07-10)
Prednisone is a commonly used steroid for short-term control of IBD flares; changes or reaffirmations in its FDA label affect prescribing and safety guidance that patients and clinicians rely on.
Dexamethasone FDA label update (2026-07-07)
This is the FDA DailyMed label for dexamethasone, which lists gastrointestinal uses including short-term use in ulcerative colitis and regional enteritis (Crohn's disease). Patients with IBD may be prescribed...
Prednisone FDA label update (2026-07-13)
The FDA/DailyMed label defines approved uses and official dosing guidance for prednisone, a corticosteroid commonly used to treat moderate-to-severe inflammatory conditions including ulcerative colitis and regional...