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.
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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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| 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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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
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