Coumadin (Warfarin Sodium) - Summary

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 indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Coumadin (Warfarin)

Alternative to Warfarin May Cut Risk of Bleeding
Source: MedicineNet Atrial Fibrillation Specialty [2009.11.16]
Title: Alternative to Warfarin May Cut Risk of Bleeding
Category: Health News
Created: 11/15/2009 4:10:00 PM
Last Editorial Review: 11/16/2009

Oldest Heart Patients May Get Most From Warfarin
Source: MedicineNet Atrial Fibrillation Specialty [2009.09.01]
Title: Oldest Heart Patients May Get Most From Warfarin
Category: Health News
Created: 8/31/2009 4:10:00 PM
Last Editorial Review: 9/1/2009

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.

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Published Studies Related to Coumadin (Warfarin)

Thrice weekly warfarin administration in haemodialysis patients. [2009.10]
BACKGROUND: Medication adherence in haemodialysis patients is often challenging due to a high pill burden, complex and dynamic medication regimens and limited patient self-interest in care. The purpose of this study was to investigate the time within target INR and safety profile of thrice weekly warfarin administration in haemodialysis patients with a clinical indication for anticoagulation and documented nonadherence to medications... CONCLUSION: In this pilot study, thrice weekly warfarin appears to be a safe and feasible dosing strategy in a select patient population. A randomized controlled trial of thrice weekly warfarin is warranted.

Dabigatran versus warfarin in patients with atrial fibrillation. [2009.09.17]
BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor... CONCLUSIONS: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.) 2009 Massachusetts Medical Society

Use of Warfarin in People with Low Glomerular Filtration Rate or on Dialysis. [2009.09.09]
Abstract Atrial fibrillation, venous thromboembolism, and access malfunction are common clinical problems in dialysis patients that prompt consideration of warfarin therapy. Atrial fibrillation appears to be more common in people with low glomerular filtration rate (GFR) or on dialysis than in the general population, but the risk of stroke in this population is not known...

Practical application of the 10-mg warfarin initiation nomogram. [2009.09]
Initiation of warfarin therapy is a clinical challenge. A 10-mg warfarin initiation nomogram was recently validated in a randomized controlled trial... The 10-mg nomogram effectively results in an early therapeutic international normalized ratio with a good safety profile in 'real-life' daily practice.

Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. [2009.08.15]
BACKGROUND: In patients with non-valvular atrial fibrillation, embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. We assessed the efficacy and safety of percutaneous closure of the LAA for prevention of stroke compared with warfarin treatment in patients with atrial fibrillation... INTERPRETATION: The efficacy of percutaneous closure of the LAA with this device was non-inferior to that of warfarin therapy. Although there was a higher rate of adverse safety events in the intervention group than in the control group, events in the intervention group were mainly a result of periprocedural complications. Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with non-valvular atrial fibrillation. FUNDING: Atritech.

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Clinical Trials Related to Coumadin (Warfarin)

Duloxetine - Warfarin Pharmacodynamic Study [Completed]
To evaluate the blood clotting effects of multiple doses of warfarin at steady state when taken at the same time as multiple doses of duloxetine as measured by changes in the International Normalised Ratio.

Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters [Completed]
This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.

Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin) [Recruiting]
Several human genes affect how medications are metabolized by the body. It is believed that knowledge of variations of these genes can help health care providers better manage an anticoagulation medicine called warfarin (Coumadin®)and as a result decrease patient problems with bleeding or the development of blood clots. This study is designed to evaluate if genetic testing can improve warfarin initiation better than usual care.

Oral Vitamin K for Warfarin Associated Coagulopathy [Active, not recruiting]
Excessive prolongation of the international normalized ratio (INR) occurs frequently in patients taking warfarin; in fact, about one in six INR values is above the desired range. Excessive prolongation of the INR is clinically important because the risk of bleeding approximately doubles for each one point increase in the INR beyond the usual therapeutic range. Thus, treatment strategies which rapidly and reliably lower an excessively prolonged INR into the desired range have the potential to reduce bleeding. When taken by patients with INR values between 4. 5 and 10, a small dose of oral vitamin K (1 mg to 2. 5mg) reduces the INR into the desired INR range in about 75% of cases within 24 hours of its administration. If warfarin is simply withheld, and no vitamin K is given, about 25% of patients will have an INR in the desired range at 24 hours. However, vitamin K is rarely given to such patients. In a recent survey carried out by our group, less than 20% of such patients would have been given low dose oral vitamin K by a group of physicians who regularly supervise warfarin therapy.

The most common treatment for excessive prolongation of the INR is to simply withhold warfarin and allow the INR to fall into the therapeutic range. Although this strategy is effective its safety has never been adequately examined. In fact, recent evidence suggests that patients with INR values of more than 6. 0 who are treated with simple warfarin withdrawal have a risk of major bleeding of 4% in the two weeks after they develop their prolonged INR.

When asked why they did not give oral vitamin K to a non-bleeding patient who has an excessively prolonged INR, physicians generally give one of three reasons: (1)They are not convinced that oral vitamin K reduces bleeding. (2) They are concerned that oral vitamin K may cause thrombosis. (3) In contrast with simply withholding warfarin, giving oral vitamin K requires a patient to visit the physician, and the physician must have a supply of vitamin K.

We hypothesize that the routine practice of not administering oral vitamin K to patients with excessively prolonged INR values is causing patients to have major, life-threatening and fatal bleeds. To convince physicians that oral vitamin K should be administered to all non-bleeding patients with INR values of more than 4. 5, we propose a study which we anticipate will demonstrate that oral vitamin K reduces bleeding, does not cause thrombosis, and can be administered at home without direct physician supervision.

To accomplish these goals, we propose a multinational, double-blind, placebo-controlled trial. We will randomize patients with INR values between 4. 5 and 10. 0 to receive 1. 25 mg of oral vitamin K or placebo and follow them for bleeding and thrombosis. Patients with INR values of more than 10. 0 will receive a single 1. 25 mg dose of oral vitamin K.

Successful completion of this study will establish a treatment standard supported by clinical data which will, in turn, change the way that patients taking warfarin who present with an excessively prolonged INR are treated.

A Study Testing the Effect and Safety of Casopitant (GW679769) While Taking Warfarin in Healthy Human Volunteers [Completed]
GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test the extent of the GW679769 affect on Warfarin levels in humans.

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PATIENT REVIEWS / RATINGS / COMMENTS

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.