Warfarin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Warfarin appears in the FDA drug-label database. Marketed as Warfarin Sodium.
- Boxed warning
- The FDA label for Warfarin carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Warfarin sodium tablets are indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. Warfarin sodium tablets are vitamin K antagonist indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism. (1) Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. (1) Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke o…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. — CARDINAL HEALTHCARE | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-01-26 |
| CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. — CARDINAL HEALTHCARE | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-01-26 |
| Failed Content Uniformity Specifications. — Taro Pharmaceuticals U.S.A., Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2014-08-25 |
Phase breakdown
Conditions being studied
Recruiting trials involving Warfarin
- A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin
- An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
- Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
- The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
Common questions
Is Warfarin FDA-approved?
Yes, marketed as Warfarin Sodium. Its FDA label carries a boxed warning.
How many recruiting trials involve Warfarin?
4 recruiting trials across 14 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.