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Warfarin

Generic Name
Warfarin
Brand Names
Coumadin, Jantoven
Drug Type
Small Molecule
Chemical Formula
C19H16O4
CAS Number
81-81-2
Unique Ingredient Identifier
5Q7ZVV76EI

Overview

Warfarin is an anticoagulant drug normally used to prevent blood clot formation as well as migration. Although originally marketed as a pesticide (d-Con, Rodex, among others), Warfarin has since become the most frequently prescribed oral anticoagulant in North America. Warfarin has several properties that should be noted when used medicinally, including its ability to cross the placental barrier during pregnancy which can result in fetal bleeding, spontaneous abortion, preterm birth, stillbirth, and neonatal death. Additional adverse effects such as necrosis, purple toe syndrome, osteoporosis, valve and artery calcification, and drug interactions have also been documented with warfarin use. Warfarin does not actually affect blood viscosity, rather, it inhibits vitamin-k dependent synthesis of biologically active forms of various clotting factors in addition to several regulatory factors.

Background

Warfarin is an anticoagulant drug normally used to prevent blood clot formation as well as migration. Although originally marketed as a pesticide (d-Con, Rodex, among others), Warfarin has since become the most frequently prescribed oral anticoagulant in North America. Warfarin has several properties that should be noted when used medicinally, including its ability to cross the placental barrier during pregnancy which can result in fetal bleeding, spontaneous abortion, preterm birth, stillbirth, and neonatal death. Additional adverse effects such as necrosis, purple toe syndrome, osteoporosis, valve and artery calcification, and drug interactions have also been documented with warfarin use. Warfarin does not actually affect blood viscosity, rather, it inhibits vitamin-k dependent synthesis of biologically active forms of various clotting factors in addition to several regulatory factors.

Indication

Indicated for: 1) Prophylaxis and treatment of venous thromboembolism and related pulmonary embolism. 2) Prophylaxis and treatment of thromboembolism associated with atrial fibrillation. 3) Prophylaxis and treatment of thromboembolism associated with cardiac valve replacement. 4) Use as adjunct therapy to reduce mortality, recurrent myocardial infarction, and thromboembolic events post myocardial infarction. Off-label uses include: 1) Secondary prevention of stroke and transient ischemic attacks in patients with rheumatic mitral valve disease but without atrial fibrillation.

Associated Conditions

  • Myocardial Infarction
  • Pulmonary Embolism
  • Stroke
  • Systemic Embolism
  • Thromboembolism
  • Transient Ischemic Attack
  • Venous Thrombosis (Disorder)

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2013/09/23
N/A
Completed
2013/07/30
Phase 1
Completed
2013/06/04
Phase 2
Terminated
2013/05/16
N/A
UNKNOWN
Chinese Academy of Medical Sciences, Fuwai Hospital
2013/04/08
Phase 1
Completed
2013/01/31
Phase 3
Completed
2013/01/01
Phase 3
Completed
Yasser Elnahas
2012/12/12
Phase 4
Completed
Cook County Health
2012/11/16
Phase 4
Completed
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
2012/09/28
Phase 2
Completed
Meshalkin Research Institute of Pathology of Circulation

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Northwind Pharmaceuticals, LLC
51655-993
ORAL
2 mg in 1 1
4/3/2023
A-S Medication Solutions
50090-5004
ORAL
7.5 mg in 1 1
8/30/2021
Zydus Lifesciences Limited
65841-052
ORAL
1 mg in 1 1
10/3/2023
Teva Pharmaceuticals USA, Inc.
0093-1715
ORAL
3 mg in 1 1
8/30/2021
Golden State Medical Supply, Inc.
51407-790
ORAL
6 mg in 1 1
2/12/2024
A-S Medication Solutions
50090-5440
ORAL
5 mg in 1 1
8/30/2021
Aidarex Pharmaceuticals LLC
33261-356
ORAL
2 mg in 1 1
1/31/2014
Zydus Pharmaceuticals USA Inc.
68382-056
ORAL
5 mg in 1 1
11/12/2022
NuCare Pharmaceuticals,Inc.
68071-4385
ORAL
3 mg in 1 1
1/17/2022
A-S Medication Solutions
50090-2586
ORAL
2.5 mg in 1 1
4/8/2025

EMA Drug Approvals

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Status
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No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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TGA Drug Approvals

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