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Massive Pradaxa Non-Valvular Atrial Fibrillation Study

By Scott Hardy


Pradaxa box and pill bottleBoehringer Ingelheim Pharmaceuticals, the makers of Pradaxa, have initiated a massive study of users of Pradaxa (dabigatran etexilate mesylate), warfarin, acetylsalicylic acid, and Xarelto (rivaroxaban.) This new study is hoping to have at least 56,000 participants by 2020. The GLORIA-AF study may also be used to track instances of internal bleeding and hemorrhage in patients who use Pradaxa. Pradaxa and warfarin has been found to significantly increase the risk of internal bleeding in patients who use the anti-coagulant drugs and could result in hospitalization and even death. Pradaxa and warfarin are used to help reduce the risk of stroke in patients with Non-Valvular Atrial Fibrillation (NVAF.) 
Atrial fibrillation, typically characterized by an irregular heartbeat, can cause blood clots to form in the heart that can travel to the brain and cause a stroke. It’s estimated that 2.3 million Americans have atrial fibrillation, and that is expected to increase to more than 5.6 million by the year 2050. Non-valvular atrial fibrillation, which amounts to 95% of diagnosed cases of atrial fibrillation, refers to cases of atrial fibrillation without rheumatic mitral valve disease, prosthetic heart valve or valve repair. Atrial fibrillation increases the risk of stroke nearly five times and is associated with up to 15% of all strokes in the US. Many of these cases may be treated with Pradaxa but patients are concerned about the elevated risk of severe internal bleeding while taking Pradaxa or warfarin after seeing the high volume of Pradaxa class action and personal injury lawsuits which have been filed by users of the drug who were hospitalized or died while taking the drug. The new GLORIA-AF study should show, at a global scale, the effect of Pradaxa in NVAF patients but it hasn’t been made clear as to whether they will track deaths or injuries in patients due to internal bleeding who are in the study. Pradaxa patients who may be experiencing internal bleeding are encouraged to see their doctor and contact an attorney.
Pradaxa and warfarin users are are reporting serious side effects like unusual bleeding from the gums, frequent nose bleeds, menstrual or vaginal bleeding that is heavier than usual, bleeding that is severe and may not be controlled and possible signs of internal bleeding. You may be experiencing internal bleeding if you have pink or brown urine, red or black stools, bruises that happen without a known cause and may get larger, if you are coughing up blood or blood clots and/or vomiting blood or your vomit includes particles that look like coffee grounds. As we stated, if you use Pradaxa and who experience at least one of these side effects you should contact your doctor immediately and also contact a Pradaxa attorney to see if you are eligible to participate in a Pradaxa class action lawsuit or file an individual Pradaxa personal injury lawsuit.
If you would like more information about filing a Pradaxa internal bleeding class action lawsuit or a Pradaxa internal bleeding personal injury lawsuit just go to the Pradaxa Internal Bleeding Class Action Lawsuit Investigation page. Pradaxa attorneys are actively investigating all claims regarding internal bleeding, hemorrhage and other problems which may have been caused by Pradaxa or warfarin.

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Updated May 3rd, 2012


All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.


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1 Comment

  • John Brinar August 17, 2015

    I was taking Warfarin for the past 9 years and developed internal bleeding. I spent a week in the hospital to receive 7 pints of blood. This saved my life.
    Is there a class action going against Warfarin???? I would be interested in joining…. I have all my medical records for my week stay in the hospital and the pictures of my stigmatas that caused the internal bleeding…
    If you cannot help, can you direct me to someone that can?

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