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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/08 | Early Phase 1 | Not yet recruiting | |||
2025/04/09 | Phase 1 | Recruiting | |||
2025/01/14 | Phase 1 | Completed | |||
2024/12/18 | Phase 4 | Recruiting | |||
2024/12/09 | Phase 1 | Completed | |||
2024/11/13 | Phase 1 | Active, not recruiting | |||
2024/10/23 | Phase 4 | Recruiting | |||
2024/09/20 | N/A | Completed | Abu Dhabi Health Services Company | ||
2024/07/23 | Phase 4 | Recruiting | |||
2024/06/10 | Not Applicable | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Aphena Pharma Solutions - Tennessee, LLC | 43353-054 | ORAL | 10 mg in 1 1 | 4/25/2015 | |
Cardinal Health 107, LLC | 55154-4697 | ORAL | 5 mg in 1 1 | 6/29/2019 | |
American Health Packaging | 68084-027 | ORAL | 2.5 mg in 1 1 | 12/14/2023 | |
Northwind Pharmaceuticals, LLC. | 51655-629 | ORAL | 5 mg in 1 1 | 4/3/2023 | |
Golden State Medical Supply, Inc. | 51407-345 | ORAL | 4 mg in 1 1 | 6/7/2022 | |
Proficient Rx LP | 63187-750 | ORAL | 10 mg in 1 1 | 5/1/2020 | |
Med-Health Pharma, LLC | 51138-061 | ORAL | 7.5 mg in 1 1 | 2/9/2011 | |
Zydus Lifesciences Limited | 65841-053 | ORAL | 2 mg in 1 1 | 10/3/2023 | |
Amneal Pharmaceuticals LLC | 65162-767 | ORAL | 6 mg in 1 1 | 11/20/2022 | |
Zydus Lifesciences Limited | 65841-064 | ORAL | 2.5 mg in 1 1 | 10/3/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
Apo-Warfarin 2mg Tablet | SIN13516P | TABLET | 2 mg | 8/12/2008 | |
Apo-Warfarin 1mg Tablet | SIN13515P | TABLET | 1 mg | 8/12/2008 | |
Apo-Warfarin 5mg Tablet | SIN13517P | TABLET | 5 mg | 8/12/2008 | |
MAREVAN TABLET 3 mg (NEW ZEALAND) | SIN08019P | TABLET | 3 mg | 2/2/1995 | |
MAREVAN TABLET 5 mg (NEW ZEALAND) | SIN08147P | TABLET | 5 mg | 5/5/1995 | |
MAREVAN TABLET 1 mg (NEW ZEALAND) | SIN08146P | TABLET | 1 mg | 5/5/1995 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Warfarin Sodium Tablets | 国药准字H20054247 | 化学药品 | 片剂 | 11/20/2020 | |
Warfarin Sodium Tablets | 国药准字HJ20171095 | 化学药品 | 片剂 | 10/25/2022 | |
Warfarin Sodium Tablets | 国药准字H31022141 | 化学药品 | 片剂(糖衣、薄膜衣) | 2/26/2020 | |
Warfarin Sodium Tablets | 国药准字H20233268 | 化学药品 | 片剂 | 3/15/2023 | |
Warfarin Sodium Tablets | 国药准字H20084641 | 化学药品 | 片剂(薄膜衣) | 9/13/2021 | |
Warfarin Sodium Tablets | 国药准字H20103600 | 化学药品 | 片剂 | 11/20/2020 | |
Warfarin Sodium Tablets | 国药准字H19993692 | 化学药品 | 片剂 | 6/12/2020 | |
Warfarin Sodium Tablets | 国药准字H31022123 | 化学药品 | 片剂 | 2/10/2020 | |
Warfarin Sodium Tablets | 国药准字H31020993 | 化学药品 | 片剂 | 11/28/2019 | |
Warfarin Sodium Tablets | 国药准字H37021314 | 化学药品 | 片剂 | 9/10/2019 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
CHEMMART WARFARIN warfarin sodium (as clathrate) 2 mg tablet bottle pack | 225715 | Medicine | A | 5/5/2016 | |
WARFARIN APOTEX warfarin sodium (as clathrate) 5 mg tablet bottle pack | 225717 | Medicine | A | 5/5/2016 | |
MAREVAN warfarin sodium 1mg tablet bottle | 12511 | Medicine | A | 8/13/1991 | |
COUMADIN warfarin sodium 1mg tablet bottle | 42269 | Medicine | A | 10/13/1992 | |
COUMADIN warfarin sodium 2mg tablet bottle | 14937 | Medicine | A | 9/9/1991 | |
GenRx WARFARIN warfarin sodium (as clathrate) 5 mg tablet bottle pack | 225727 | Medicine | A | 5/5/2016 | |
CHEMMART WARFARIN warfarin sodium (as clathrate) 1 mg tablet bottle pack | 225716 | Medicine | A | 5/5/2016 | |
GenRx WARFARIN warfarin sodium (as clathrate) 1 mg tablet bottle pack | 225724 | Medicine | A | 5/5/2016 | |
MAREVAN warfarin sodium 5mg tablet bottle | 12514 | Medicine | A | 8/13/1991 | |
COUMADIN warfarin sodium 5mg tablet bottle | 42279 | Medicine | A | 10/13/1992 |