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Cure8 regulatory brief
Vitamin K1 FDA label update (2026-08-09)
Procedures and surgery
Regulatory Update
Adult patients
Clinicians
Newly Diagnosed
Ulcerative colitis
Inflammatory bowel disease
Why This Matters
People with IBD (Crohn’s disease or ulcerative colitis) can develop vitamin K deficiency from malabsorption; this label clarifies that Vitamin K1 Injection is indicated for such situations and highlights important safety warnings about route of administration and preservative risks in infants.
Who Should Pay Attention
Patients with Crohn’s disease or ulcerative colitis at risk for vitamin K deficiency; clinicians (gastroenterologists, hospitalists, pharmacists); parents/caregivers of neonates and infants.
Study Snapshot
Story typeRegulatory
Evidence typeRegulatory update
Study statusHuman prescription drug
Source depthRegulatory record
What To Know
This is an FDA/dailyMed label update for Vitamin K1 (phytonadione) Injection.
The label lists indications including treatment of hypoprothrombinemia caused by vitamin K deficiency or interference, and explicitly names gastrointestinal conditions that can cause vitamin K deficiency such as ulcerative colitis, regional enteritis (Crohn’s disease), celiac disease, and intestinal resection.
It also includes boxed warnings about fatal hypersensitivity reactions with intravenous or intramuscular administration and cautions about benzyl alcohol preservative in neonates.
The label recommends subcutaneous administration whenever feasible to reduce risk of severe hypersensitivity and advises using benzyl alcohol–free formulations in neonates/infants when available. It also warns about aluminum toxicity with prolonged parenteral administration in patients with impaired kidney function and premature neonates.
This update is a regulatory drug-label record (dailyMed) and summarizes prescribing information rather than new clinical trial results. It is intended to inform safe prescribing and use of Vitamin K1 Injection.
Keep In Mind
This is a regulatory label update (dailyMed/FDA prescribing information). It reflects approved indications and safety warnings rather than new research results. Consult a clinician for individualized medical advice.
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
SponsorHospira, Inc.
Study typeDrug Label Update
Indexed viaopenFDA
Source typeRegulatory record
PublishedAug 9, 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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