WARNING: BLEEDING RISK
Warfarin sodium can cause major or fatal bleeding. Bleeding is more likely to occur during the starting period and with a higher dose (resulting in a higher INR). Risk factors for bleeding include high intensity of anticoagulation (INR >4.0), age ≥65, highly variable INRs, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, serious heart disease, anemia, malignancy, trauma, renal insufficiency, concomitant drugs (see PRECAUTIONS), and long duration of warfarin therapy. Regular monitoring of INR should be performed on all treated patients. Those at high risk of bleeding may benefit from more frequent INR monitoring, careful dose adjustment to desired INR, and a shorter duration of therapy. Patients should be instructed about prevention measures to minimize risk of bleeding and to report immediately to physicians signs and symptoms of bleeding (see PRECAUTIONS: Information for Patients).
Jantoven™ (crystalline warfarin sodium), is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors.
Jantoven™ (Warfarin Sodium Tablets, USP) is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism.
Jantoven™ is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement.
Jantoven™ is indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Media Articles Related to Jantoven (Warfarin)
Watchman Attains Efficacy Superiority Over Warfarin in AF
Source: Medscape Medical News Headlines [2013.05.10]
The Watchman left-atrial appendage occluder had previously been found noninferior to warfarin in patients with nonvalvular atrial fibrillation; now, with an average of 45 months of follow-up, it's not only noninferior, it's superior, by some statistical measures.
Continuous Warfarin Safer in Ablation (CME/CE)
Source: MedPage Today Cardiovascular [2013.05.10]
DENVER (MedPage Today) -- Keeping warfarin (Coumadin) on board for an atrial fibrillation ablation procedure is safer than bridging with heparin, a randomized trial showed.
Common Antidepressants Tied to Higher Bleeding Risk in Warfarin Users: Study
Source: MedicineNet warfarin Specialty [2012.11.09]
Title: Common Antidepressants Tied to Higher Bleeding Risk in Warfarin Users: Study
Category: Health News
Created: 11/8/2012 12:35:00 PM
Last Editorial Review: 11/9/2012 12:00:00 AM
New Anti-Clotting Drug Beats Warfarin, Study Says
Source: MedicineNet warfarin Specialty [2012.10.02]
Title: New Anti-Clotting Drug Beats Warfarin, Study Says
Category: Health News
Created: 10/1/2012 8:06:00 PM
Last Editorial Review: 10/2/2012 12:00:00 AM
Clot-Buster Doesn't Raise Bleeding Risk in Warfarin Patients: Study
Source: MedicineNet alteplase Specialty [2012.05.11]
Title: Clot-Buster Doesn't Raise Bleeding Risk in Warfarin Patients: Study
Category: Health News
Created: 5/10/2012 6:05:00 PM
Last Editorial Review: 5/11/2012 12:00:00 AM
Published Studies Related to Jantoven (Warfarin)
A placebo-controlled randomized trial of warfarin in idiopathic pulmonary
and declines in FVC... CONCLUSIONS: This study did not show a benefit for warfarin in the treatment of
Risks for Stroke, Bleeding, and Death in Patients With Atrial Fibrillation Receiving Dabigatran or Warfarin in Relation to the CHADS2 Score: A Subgroup Analysis of the RE-LY Trial. [2011.11.15]
Background: CHADS(2) is a simple, validated risk score for predicting the risk for stroke in patients with atrial fibrillation not treated with anticoagulants.
Apixaban versus warfarin in patients with atrial fibrillation. [2011.09.15]
BACKGROUND: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin... CONCLUSIONS: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. [2011.09.08]
BACKGROUND: The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin... CONCLUSIONS: In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.).
A multicenter, randomized trial comparing heparin/warfarin and acetylsalicylic acid as primary thromboprophylaxis for 2 years after the Fontan procedure in children. [2011.08.02]
OBJECTIVES: The purpose of this study was to compare the safety and efficacy of acetylsalicylic acid (ASA) and warfarin for thromboprophylaxis after the Fontan procedure. BACKGROUND: Fontan surgery is the definitive palliation for children with single-ventricle physiology. Thrombosis is an important complication; the optimal thromboprophylaxis strategy has not been determined... CONCLUSIONS: There was no significant difference between ASA and heparin/warfarin as primary thromboprophylaxis in the first 2 years after Fontan surgery. The thrombosis rate was suboptimal for both regimens, suggesting alternative approaches should be considered. (International Multi Centre Randomized Clinical Trial Of Anticoagulation In Children Following Fontan Procedures; NCT00182104). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Clinical Trials Related to Jantoven (Warfarin)
PerMIT: Warfarin: A Trial Comparing Usual Care Warfarin Initiation to PerMIT Pharmacogenetic Guided Warfarin Therapy [Recruiting]
Warfarin is the most commonly used oral anticoagulant medicine (blood thinner). Although
this medicine works well, it is difficult to know how much medicine a patient needs. Many
things affect how much medicine a patient needs and doses can be very different from patient
to patient. It is important for patients to get the right dose to prevent clotting or
bleeding problems that can happen with this medicine if the dose is too low or too high.
These problems can be life-threatening. To help find the right dose, patients on warfarin
must have frequent blood tests to measure how well the medicine is working. The
investigators know differences in people's genes can affect how much warfarin medicine
someone needs, but they don't yet know with certainty how to use this information in making
patient care decisions. The hypothesis of this study is that using a patients warfarin
related genetic information incorporated into a computer algorithm to be used by a warfarin
provider will lead to better warfarin management compared to usual care.
A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin [Not yet recruiting]
The primary purpose of this study is to determine whether the treatment with AZD9668 will
affect the metabolism and effect of Warfarin.
Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin [Recruiting]
The purpose of this study is to determine whether DNA analysis improves the efficiency of
dosing and safety in patients who are being started on warfarin therapy. Warfarin, a blood
thinner (anticoagulant) prescribed to 1-2 million patients in the US, is a leading cause of
drug-related adverse events (e. g., severe bleeding), in large part due to dramatic (20-fold)
differences between individuals in dose requirements. At least half of this variability now
can be explained by 3 common genetic variants, age, body size, and sex; however, warfarin
therapy continues to begin with the same dose in every patient with the correct individual
dose determined by trial and error. This study proposes to determine genetic variations the
same day from DNA simply obtained by swabbing the inside of the cheek and use this
information to determine the proper dose regimen individually in each patient. The aim is to
show that the investigators can achieve more rapid, efficient, and safe dosing in up to
500-1000 individuals who are initiating warfarin therapy for various clotting disorders
across a large healthcare system in order to demonstrate improved dosing effectiveness,
efficiency, and safety with genetic-based dosing, which could lead to a nationwide
application resulting in as much as a $1 billion dollar annual benefit in healthcare
A Study of the Effect of Dulaglutide on the Action of Warfarin in Healthy Subjects [Recruiting]
Warfarin is a commonly used drug to prevent the blood from clotting. The purpose of this
study is to determine if LY2189265 affects how warfarin works. The study involves two
different treatments (Treatment 1: warfarin; treatment 2: LY2189265 + warfarin) separated by
a minimum washout period of 24 days. In treatment 1 the subject will receive 10 mg of
warfarin on day 1. In treatment 2 the subject will receive a 1. 5 mg dose of dulaglutide as
an injection on Day 1 and then a 10 mg dose of warfarin on Day 3. Subjects will be randomly
assigned into different treatment sequences. Subjects in Treatment Sequence A will receive
Treatment 1 then Treatment 2. Subjects in Treatment Sequence B will receive Treatment 2 then
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN) [Recruiting]
The WARFARIN Study is a clinical trial designed to determine if the use of genetic
information related to warfarin sensitivity can help create a dose of warfarin that will
result in less hospitalizations and deaths related to warfarin.
Reports of Suspected Jantoven (Warfarin) Side Effects
Drug Interaction (2),
Status Epilepticus (2),
Drug Dose Omission (1),
Dizziness Postural (1),
Anticonvulsant Drug Level Below Therapeutic (1),
AGE-Related Macular Degeneration (1),
International Normalised Ratio Decreased (1),
Drug Administration Error (1),
Drug Level Decreased (1),
Blood Pressure Increased (1), more >>
Page last updated: 2013-05-10