Pradaxa
FDA Evaluating Risk of Serious Bleeding Episodes with Prescription Drug Pradaxa
Pradaxa, (dabigatran etexilate) is an oral blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in October 2010. Pradaxa is in the class of anticoagulant (or anti-clotting) blood thinners called “direct thrombin inhibitors.” The drug is used to help prevent serious blood clots and strokes in people with atrial fibrillation. Atrial fibrillation is a heart condition in which the upper chambers of the heart, the atria, fail to contract fully causing potential stagnant blood and clot formation. Most patients with atrial fibrillation are candidates for long term anticoagulation, and until Pradaxa, patients were treated with oral Coumadin (warfarin), injectable low molecular weight heparin, or less effective anti-platelet medications like aspirin. Warfarin has been most physicians’ treatment of choice for stroke prevention. However, warfarin has problems involved with its use in the U.S.
With warfarin, it takes several days for the anticoagulation of warfarin to take effect and during that time the patient needs frequent testing, sometimes daily. It may take several weeks to get the dosing just right and even after adequate anticoagulation is reached, monthly blood testing is necessary. Many foods in the diet interfere with warfarin and may drugs interfere as well. The therapeutic window for warfarin is very narrow, so it is common to be over or under anticoagulated.
Pradaxa is approved at a single fixed dose for most patients. It is dosed at 150 mg twice daily and is effective within hours of its first dose. Pradaxa has fewer drug interactions than warfarin which is affected by both diet and other medications. Pradaxa also claims to be safe at it’s standard dosing levels, and does not need monthly blood tests to confirm adequate anticoagulation unlike warfarin. Pradaxa seemingly is an ideal drug for patients with atrial fibrillation.
However, studies have shown that patients on Pradaxa have a 33% higher risk of heart attack or severe symptoms of heart disease when compared with patients taking warfarin. Consequently, the FDA is investigating an unusually high number of reports of serious bleeding related to Pradaxa’s use as well.
To date there have been a number of severe injuries and deaths associated with Pradaxa. If you or a loved one suffered from Pradaxa related internal bleeding, or may be a victim of a Pradaxa related injury or death, you may be eligible for financial compensation. With over three decades of experience, the law office of Rudolph F.X. Migliore, P.C., is well positioned to help those who have been harmed by Pradaxa. Our firm works with nationally recognized co-counsel to reach major verdicts and settlements. Call Rudy Migliore at 631-543-3663 or fill out a contact form for a free case evaluation.
Some of Pradaxa’s harmful side effects include:
- Internal bleeding
- Gastrointestinal bleeding (GI bleed)
- Brain hemorrhage
- Kidney bleeding
- Death
The RE-LY clinical trial found that up to 16.4% of patients taking Pradaxa may experience internal hemorrhaging. They have also found that 17.4% of its users who needed emergency surgery experienced major bleeding resulting from use of Pradaxa. There have been reports of 260 Pradaxa related deaths worldwide.
Symptoms of excessive bleeding include:
- Lethargy
- Unusual bruising or bleeding
- Pink or brown urine
- Red or black tarry stools
- Coughing up blood
- Vomit that resembles blood or looks like coffee grounds
- Headaches
- Bleeding from gums
- Frequent nosebleeds
- Weakness and swelling of the arms, hands, feet, ankles or lower legs
- Joint pain or swelling
- Dizziness
- Death
With over three decades of experience, the law office of Rudolph F.X. Migliore, P.C., is well positioned to help those who have been harmed by Pradaxa. Our firm works with nationally recognized co-counsel to reach major verdicts and settlements. Call Rudy Migliore at 631-543-3663 or fill out a contact form for a free case evaluation.
Pradaxa, (dabigatran etexilate) is an oral blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in October 2010. Pradaxa is in the class of anticoagulant (or anti-clotting) blood thinners called “direct thrombin inhibitors.” The drug is used to help prevent serious blood clots and strokes in people with atrial fibrillation. Atrial fibrillation is a heart condition in which the upper chambers of the heart, the atria, fail to contract fully causing potential stagnant blood and clot formation.
Most patients with atrial fibrillation are candidates for long term anticoagulation, and until Pradaxa, patients were treated with oral Coumadin (warfarin), injectable low molecular weight heparin, or less effective anti-platelet medications like aspirin. Warfarin has been most physicians’ treatment of choice for stroke prevention. However, warfarin has problems involved with its use in the U.S.
With warfarin, it takes several days for the anticoagulation of warfarin to take effect and during that time the patient needs frequent testing, sometimes daily. It may take several weeks to get the dosing just right and even after adequate anticoagulation is reached, monthly blood testing is necessary. Many foods in the diet interfere with warfarin and may drugs interfere as well. The therapeutic window for warfarin is very narrow, so it is common to be over or under anticoagulated.
Pradaxa is approved at a single fixed dose for most patients. It is dosed at 150 mg twice daily and is effective within hours of its first dose. Pradaxa has fewer drug interactions than warfarin which is affected by both diet and other medications. Pradaxa also claims to be safe at it’s standard dosing levels, and does not need monthly blood tests to confirm adequate anticoagulation unlike warfarin. Pradaxa seemingly is an ideal drug for patients with atrial fibrillation.
However, studies have shown that patients on Pradaxa have a 33% higher risk of heart attack or sever symptoms of heart disease when compared with patients taking warfarin. Consequently, the FDA is investigating an unusually high number of reports of serious bleeding linked to Pradaxa’s use as well.
To date there have been a number of severe injuries and deaths associated with Pradaxa. If you or a loved one suffered from Pradaxa related internal bleeding, or may be a victim of a Pradaxa related injury or death, you may be eligible for financial compensation. With over three decades of experience, the law office of Rudolph F.X. Migliore, P.C., is well positioned to help those who have been harmed by Pradaxa. Our firm works with nationally recognized co-counsel to reach major verdicts and settlements. Call Rudy Migliore at 631-543-3663 or fill out a contact form for a free case evaluation.
Some of Pradaxa’s harmful side effects include:
Most patients with atrial fibrillation are candidates for long term anticoagulation, and until Pradaxa, patients were treated with oral Coumadin (warfarin), injectable low molecular weight heparin, or less effective anti-platelet medications like aspirin. Warfarin has been most physicians’ treatment of choice for stroke prevention. However, warfarin has problems involved with its use in the U.S.
With warfarin, it takes several days for the anticoagulation of warfarin to take effect and during that time the patient needs frequent testing, sometimes daily. It may take several weeks to get the dosing just right and even after adequate anticoagulation is reached, monthly blood testing is necessary. Many foods in the diet interfere with warfarin and may drugs interfere as well. The therapeutic window for warfarin is very narrow, so it is common to be over or under anticoagulated.
Pradaxa is approved at a single fixed dose for most patients. It is dosed at 150 mg twice daily and is effective within hours of its first dose. Pradaxa has fewer drug interactions than warfarin which is affected by both diet and other medications. Pradaxa also claims to be safe at it’s standard dosing levels, and does not need monthly blood tests to confirm adequate anticoagulation unlike warfarin. Pradaxa seemingly is an ideal drug for patients with atrial fibrillation.
However, studies have shown that patients on Pradaxa have a 33% higher risk of heart attack or sever symptoms of heart disease when compared with patients taking warfarin. Consequently, the FDA is investigating an unusually high number of reports of serious bleeding linked to Pradaxa’s use as well.
To date there have been a number of severe injuries and deaths associated with Pradaxa. If you or a loved one suffered from Pradaxa related internal bleeding, or may be a victim of a Pradaxa related injury or death, you may be eligible for financial compensation. With over three decades of experience, the law office of Rudolph F.X. Migliore, P.C., is well positioned to help those who have been harmed by Pradaxa. Our firm works with nationally recognized co-counsel to reach major verdicts and settlements. Call Rudy Migliore at 631-543-3663 or fill out a contact form for a free case evaluation.
Some of Pradaxa’s harmful side effects include:
- Internal bleeding
- Gastrointestinal bleeding (GI bleed)
- Brain hemorrhage
- Kidney bleeding
- Death
The RE-LY clinical trial found that up to 16.4% of patients taking Pradaxa may experience internal hemorrhaging. They have also found that 17.4% of its users who needed emergency surgery experienced major bleeding resulting from use of Pradaxa. There have been reports of 260 Pradaxa related deaths worldwide.
Symptoms of excessive bleeding include:
- Lethargy
- Unusual bruising or bleeding
- Pink or brown urine
- Red or black tarry stools
- Coughing up blood
- Vomit that resembles blood or looks like coffee grounds
- Headaches
- Bleeding from gums
- Frequent nosebleeds
- Weakness and swelling of the arms, hands, feet, ankles or lower legs
- Joint pain or swelling
- Dizziness
- Death
With over three decades of experience, the law office of Rudolph F.X. Migliore, P.C., is well positioned to help those who have been harmed by Pradaxa. Our firm works with nationally recognized co-counsel to reach major verdicts and settlements. Call Rudy Migliore at 631-543-3663 or fill out a contact form for a free case evaluation.
Pradaxa, (dabigatran etexilate) is an oral blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in October 2010. Pradaxa is in the class of anticoagulant (or anti-clotting) blood thinners called “direct thrombin inhibitors.” The drug is used to help prevent serious blood clots and strokes in people with atrial fibrillation. Atrial fibrillation is a heart condition in which the upper chambers of the heart, the atria, fail to contract fully causing potential stagnant blood and clot formation.
Most patients with atrial fibrillation are candidates for long term anticoagulation, and until Pradaxa, patients were treated with oral Coumadin (warfarin), injectable low molecular weight heparin, or less effective anti-platelet medications like aspirin. Warfarin has been most physicians’ treatment of choice for stroke prevention. However, warfarin has problems involved with its use in the U.S.
With warfarin, it takes several days for the anticoagulation of warfarin to take effect and during that time the patient needs frequent testing, sometimes daily. It may take several weeks to get the dosing just right and even after adequate anticoagulation is reached, monthly blood testing is necessary. Many foods in the diet interfere with warfarin and may drugs interfere as well. The therapeutic window for warfarin is very narrow, so it is common to be over or under anticoagulated.
Pradaxa is approved at a single fixed dose for most patients. It is dosed at 150 mg twice daily and is effective within hours of its first dose. Pradaxa has fewer drug interactions than warfarin which is affected by both diet and other medications. Pradaxa also claims to be safe at it’s standard dosing levels, and does not need monthly blood tests to confirm adequate anticoagulation unlike warfarin. Pradaxa seemingly is an ideal drug for patients with atrial fibrillation.
However, studies have shown that patients on Pradaxa have a 33% higher risk of heart attack or sever symptoms of heart disease when compared with patients taking warfarin. Consequently, the FDA is investigating an unusually high number of reports of serious bleeding linked to Pradaxa’s use as well.
To date there have been a number of severe injuries and deaths associated with Pradaxa. If you or a loved one suffered from Pradaxa related internal bleeding, or may be a victim of a Pradaxa related injury or death, you may be eligible for financial compensation. With over three decades of experience, the law office of Rudolph F.X. Migliore, P.C., is well positioned to help those who have been harmed by Pradaxa. Our firm works with nationally recognized co-counsel to reach major verdicts and settlements. Call Rudy Migliore at 631-543-3663 or fill out a contact form for a free case evaluation.
Some of Pradaxa’s harmful side effects include:
Most patients with atrial fibrillation are candidates for long term anticoagulation, and until Pradaxa, patients were treated with oral Coumadin (warfarin), injectable low molecular weight heparin, or less effective anti-platelet medications like aspirin. Warfarin has been most physicians’ treatment of choice for stroke prevention. However, warfarin has problems involved with its use in the U.S.
With warfarin, it takes several days for the anticoagulation of warfarin to take effect and during that time the patient needs frequent testing, sometimes daily. It may take several weeks to get the dosing just right and even after adequate anticoagulation is reached, monthly blood testing is necessary. Many foods in the diet interfere with warfarin and may drugs interfere as well. The therapeutic window for warfarin is very narrow, so it is common to be over or under anticoagulated.
Pradaxa is approved at a single fixed dose for most patients. It is dosed at 150 mg twice daily and is effective within hours of its first dose. Pradaxa has fewer drug interactions than warfarin which is affected by both diet and other medications. Pradaxa also claims to be safe at it’s standard dosing levels, and does not need monthly blood tests to confirm adequate anticoagulation unlike warfarin. Pradaxa seemingly is an ideal drug for patients with atrial fibrillation.
However, studies have shown that patients on Pradaxa have a 33% higher risk of heart attack or sever symptoms of heart disease when compared with patients taking warfarin. Consequently, the FDA is investigating an unusually high number of reports of serious bleeding linked to Pradaxa’s use as well.
To date there have been a number of severe injuries and deaths associated with Pradaxa. If you or a loved one suffered from Pradaxa related internal bleeding, or may be a victim of a Pradaxa related injury or death, you may be eligible for financial compensation. With over three decades of experience, the law office of Rudolph F.X. Migliore, P.C., is well positioned to help those who have been harmed by Pradaxa. Our firm works with nationally recognized co-counsel to reach major verdicts and settlements. Call Rudy Migliore at 631-543-3663 or fill out a contact form for a free case evaluation.
Some of Pradaxa’s harmful side effects include:
- Internal bleeding
- Gastrointestinal bleeding (GI bleed)
- Brain hemorrhage
- Kidney bleeding
- Death
The RE-LY clinical trial found that up to 16.4% of patients taking Pradaxa may experience internal hemorrhaging. They have also found that 17.4% of its users who needed emergency surgery experienced major bleeding resulting from use of Pradaxa. There have been reports of 260 Pradaxa related deaths worldwide.
Symptoms of excessive bleeding include:
- Lethargy
- Unusual bruising or bleeding
- Pink or brown urine
- Red or black tarry stools
- Coughing up blood
- Vomit that resembles blood or looks like coffee grounds
- Headaches
- Bleeding from gums
- Frequent nosebleeds
- Weakness and swelling of the arms, hands, feet, ankles or lower legs
- Joint pain or swelling
- Dizziness
- Death
With over three decades of experience, the law office of Rudolph F.X. Migliore, P.C., is well positioned to help those who have been harmed by Pradaxa. Our firm works with nationally recognized co-counsel to reach major verdicts and settlements. Call Rudy Migliore at 631-543-3663 or fill out a contact form for a free case evaluation.