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Coumadin (Warfarin Sodium) - Summary

 
 



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).

 

COUMADIN SUMMARY

COUMADIN® TABLETS
(Warfarin Sodium Tablets, USP) Crystalline
COUMADIN® FOR INJECTION
(Warfarin Sodium for Injection, USP)

COUMADIN (crystalline warfarin sodium) is an anticoagulant which acts by inhibiting vitamin K-dependent coagulation factors.

COUMADIN (Warfarin Sodium) is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism.

COUMADIN is indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement.

COUMADIN is indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.


See all Coumadin indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Coumadin (Warfarin)

Implanted device shows potential as alternative to warfarin for stroke prevention in patients with atrial fibrillation
Source: Medical Devices / Diagnostics News From Medical News Today [2014.11.17]
Vivek Y. Reddy, M.D., of the Icahn School of Medicine at Mount Sinai, New York, and colleagues examined the long-term efficacy and safety, compared to warfarin, of a device to achieve left atrial...

Study: Aspirin Might Work Instead of Warfarin for Deep Vein Clots
Source: MedicineNet Deep Vein Thrombosis Specialty [2014.08.27]
Title: Study: Aspirin Might Work Instead of Warfarin for Deep Vein Clots
Category: Health News
Created: 8/26/2014 12:35:00 PM
Last Editorial Review: 8/27/2014 12:00:00 AM

Comparing the New Blood Thinners to Warfarin
Source: MedicineNet enoxaparin Specialty [2013.06.03]
Title: Comparing the New Blood Thinners to Warfarin
Category: Health News
Created: 6/1/2013 11:00:00 AM
Last Editorial Review: 6/3/2013 12:00:00 AM

Herbal Supplements, Warfarin Can Be Hazardous Mix
Source: MedicineNet Saw Palmetto Specialty [2010.05.14]
Title: Herbal Supplements, Warfarin Can Be Hazardous Mix
Category: Health News
Created: 5/13/2010 4:10:00 PM
Last Editorial Review: 5/14/2010

Aspirin as effective as warfarin and safer in stroke prevention
Source: The Doctors Lounge - Neurology
Intracranial stenosis is caused by atherosclerosis - fatty deposits that build up on the inner walls of the arteries and restrict blood flow.

more news >>

Published Studies Related to Coumadin (Warfarin)

A placebo-controlled randomized trial of warfarin in idiopathic pulmonary fibrosis. [2012]
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.

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Clinical Trials Related to Coumadin (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 outcomes.

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 Treatment 1.

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.

more trials >>

Reports of Suspected Coumadin (Warfarin) Side Effects

International Normalised Ratio Increased (352)Anaemia (219)Fall (123)Gastrointestinal Haemorrhage (107)Haemorrhage (102)International Normalised Ratio Decreased (90)Epistaxis (87)Pulmonary Embolism (79)Deep Vein Thrombosis (78)Rectal Haemorrhage (73)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 6 ratings/reviews, Coumadin has an overall score of 5.50. The effectiveness score is 8.33 and the side effect score is 6.33. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Coumadin review by 60 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   dvt
Dosage & duration:   varied (dosage frequency: once a day) for the period of 6 mo.
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The clots eventually completely dissolved over the course of the treatment.
Side effects:   I had to be careful shaving my legs. I had to pay attention to which foods and alcohol would alter my prothrombin time and make it necessary to take a higher or lower dosage, i. e. be sure to have the guacamole if I indulged in a margarita!
Comments:   After being diagnosed with thrombophlebitis and deep vein thrombosis twice - once in each leg - the first time through a veinogram and the second time through an ultrasound, I had 11 days in the hospital both times on IV heparin with complete bed rest while my clots which were in the saphenous vein all the way up to the femoral junction, were dissolving. After my release from the hospital I had 6 months of coumadin therapy. Through the years I have had sclerotherapy and infrared venous closure procedures. My vein disease has much improved except for capillary bruing/bleeding under the skin which would be considered more of a cosmetic problem, except that it bleeds in one spot that has come to my skin's surface when I bump it,scratch it, or hit it shaving.

 

Coumadin review by 61 year old male patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   heart murmer
Dosage & duration:   14.5 mg / day taken 1 per day for the period of continually
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   reduced risk of stroke
Side effects:   excesive bleeding
Comments:   14.5 mg daily

 

Coumadin review by care giver of 43 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   leg blood clot, dvt
Dosage & duration:   6mg taken daily for the period of 2months
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   The leg clot would not extend nor would other clots form, potentially causing death.
Side effects:   These were severe and included extreme and continuous nausea, feeling generally shitty (technical term employed by patient), no libido and inability to maintain erection during sex, orgasms that petered out and gave little pleasure, no overall energy for life. Patient decided to stop medication and try natural/alternative substance to thin the blood. this resulted in an extension of the clot and increased severity of pain, leading to emergency room visit and subsequent use of different blood thinner, syntron.
Comments:   Treatment included 2months of heparin injections in abdomen. Coumadin was given daily after the injections were stopped, at 6mg. The discontinuation of this medication caused an extension of the clot and re-admittance to hospital and another drug for blood thinning was given. Eventually, 6 months later, a doctor prescribed a compression stocking, which helped dramatically with swelling and pain. The Syntron blood thinner had no noticeable side-effects. Except possibly a still reduced libido.

See all Coumadin reviews / ratings >>

Page last updated: 2014-11-17

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