BOXED WARNING
- COUMADIN can cause major or fatal bleeding [see
Warnings and Precautions (5.1)
].
- Perform regular monitoring of INR in all treated patients [see
Dosage and Administration (2.1)
].
- Drugs, dietary changes, and other factors affect INR levels achieved with COUMADIN therapy [see
Drug Interactions (7)
].
- Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see
Patient Counseling Information (17)
].
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COUMADIN SUMMARY
COUMADIN (warfarin sodium) is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors.
COUMADIN® is 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
COUMADIN has 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.
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NEWS HIGHLIGHTSMedia Articles Related to Coumadin (Warfarin)
Genotyping Lowers Warfarin Risk in Hip or Knee Replacement Source: Medscape Anesthesiology Headlines [2017.09.26] Considering variants of three genes that affect response to warfarin improved the safety of using the drug. Medscape Medical News
Published Studies Related to Coumadin (Warfarin)
Genetics and the clinical response to warfarin and edoxaban: findings from the
randomised, double-blind ENGAGE AF-TIMI 48 trial. [2015] anticoagulant rather than warfarin... INTERPRETATION: CYP2C9 and VKORC1 genotypes identify patients who are more likely
Relationship between time in therapeutic range and comparative treatment effect
of rivaroxaban and warfarin: results from the ROCKET AF trial. [2014] CONCLUSIONS: The treatment effect of rivaroxaban compared with warfarin for the
Outcomes of temporary interruption of rivaroxaban compared with warfarin in
patients with nonvalvular atrial fibrillation: results from the rivaroxaban once
daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for
prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). [2014] CONCLUSIONS: TI of oral anticoagulation is common and is associated with
Efficacy and safety of rivaroxaban compared with warfarin in patients with
peripheral artery disease and non-valvular atrial fibrillation: insights from
ROCKET AF. [2014] CONCLUSION: Patients with PAD in ROCKET AF did not have a statistically
Apixaban vs. warfarin with concomitant aspirin in patients with atrial
fibrillation: insights from the ARISTOTLE trial. [2014] CONCLUSION: Apixaban had similar beneficial effects on stroke or systemic
Clinical Trials Related to Coumadin (Warfarin)
Role of Coumadin in Preventing Thromboembolism in Atrial Fibrillation (AF) Patients Undergoing Catheter Ablation [Completed]
Drug Interaction Study of Isavuconazole and Warfarin in Healthy Male Subjects [Completed]
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
pharmacokinetics (PK) of warfarin after single dose administration.
Pharmacogenetics of Warfarin Induction and Inhibition [Completed]
This research study will help determine how a person's genetic makeup affects their response
to drugs, the ability of the body to break down drugs, and their potential to experience an
interaction between drugs. The investigators are investigating the drug interactions with
the commonly used anticoagulant drug called warfarin. Warfarin is used for the treatment and
prevention of life-threatening abnormal blood clots such as deep vein thrombosis, heart
attacks, and strokes. The investigators chose warfarin for this study because it is a
commonly used drug and must be monitored closely to avoid side effects. The investigators
are interested in studying whether individuals with certain genetic profiles react
differently to warfarin when it is combined with other drugs. This research is being done to
see if certain genetic profiles require us to adjust warfarin doses differently than is
needed for the general population. Genetic profiles of subjects are determined from their
participation in the Pharmacogenetics Registry study (investigator Richard Brundage,
University of Minnesota).
The study hypothesis is: Functionally defective CYP2C9 alleles attenuate the
warfarin-fluconazole inhibitory interaction and exacerbate the warfarin-rifampin inductive
interaction.
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.
Genetic Response to Warfarin in Healthy Subjects [Completed]
The purpose of this study is to determine the importance of genetic differences on
individuals' response to warfarin in a group of healthy subjects. Warfarin is also known by
the "trade name" Coumadin and is in a class of medications called anticoagulants or "blood
thinners." Warfarin works by reducing the blood's ability to make clots. It is used to
stop blood clots from forming or growing larger in your blood and blood vessels. Warfarin
is prescribed for many conditions, including for people with certain types of irregular
heartbeat, people with replacement or mechanical heart valves, people who have suffered a
heart attack, people who have had orthopedic surgery, or who have a history of having blood
clots. Warfarin is used to prevent or treat deep vein thrombosis (swelling and blood clot
in a vein), pulmonary embolism (a blood clot in the lung), and strokes (a blood clot in the
brain). Researchers have found that certain genes may affect how a person's body will break
down or react to warfarin. If genetic information can help doctors better determine the
best dose of warfarin before it is first given, this may help the doctors get patients to
the correct levels of blood thinning and thereby reduce the risk of bleeding or the risk of
developing a blood clot. The expectation of this study is that this information will
ultimately improve warfarin therapy while lessening the risks associated with dosing errors.
This study is considered investigational because the subjects are healthy and not being
prescribed warfarin for clinical care.
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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. |
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| 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. |
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Page last updated: 2017-09-26
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