Did you have a serious bleeding disorder while taking Pradaxa? This blood-thinning medication is taken by thousands of people who suffer from atrial fibrillation, a type of irregular heartbeat that can cause blood clots and strokes. Unfortunately, Pradaxa has been linked to severe side effects, including heart attack, hemorrhagic strokes, cerebral hemorrhage, severe bleeding, and death. Older Americans and people with impaired renal function have the highest risk of Pradaxa side effects. If you have suffered from a Pradaxa bleeding disorder, you may have a Pradaxa lawsuit.
What You Can Do & How a Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Pradaxa Overview
Pradaxa (dabigatran) is an anti-clotting blood-thinning medication created by the pharmaceutical company Boehringer Ingelheim, approved by the U.S. Food and Drug Administration (FDA) in 2010 to prevent ischemic strokes.
Pradaxa was initially approved for a much smaller group of patients — people who had recently had hip or knee replacement surgery, and had a high risk of blood clots that could cause stroke. When its approval was expanded to people with atrial fibrillation, suddenly large numbers of people began taking Pradaxa instead of other blood-thinning drugs.
Pradaxa was developed as an alternative to warfarin, a notoriously problematic blood-thinner. Early safety studies found that Pradaxa had the same risk of bleeding as warfarin. Unlike warfarin, however, the blood-thinning effects of Pradaxa can only be reversed with 2-3 hours of dialysis. What does this mean? When a patient begins bleeding unexpectedly, a doctor may be unable to stop the bleeding. In fact, nearly 20% of Pradaxa patients who required emergency surgery suffered a major, life-threatening bleed.
Pradaxa Bleeding Deaths
Hundreds of people have died from serious bleeding after taking Pradaxa. On November 6, 2011, the European Medicines Agency (EMA) announced that it was aware of at least 256 deaths caused by Pradaxa. All of these cases involved serious bleeding that led to death. In response, the U.S. FDA announced that it would be investigating post-marking reports of fatal bleeding events in Pradaxa patients. The FDA specifically warned doctors not to prescribe Pradaxa to patients with poor kidney function.
However, the FDA warning may not have gone far enough. A group of New Zealand doctors were prompted to investigate Pradaxa after nearly 100 patients suffered serious bleeding disorders after taking Pradaxa. The doctors found that people who were over 75 years of age who had impaired renal function had a higher risk of serious bleeding. One person died from serious bleeding.
14 deaths in Japan prompted health authorities to issue stern warnings to doctors regarding the high risk of bleeding. Australian authorities also updated the safety labeling to warn of the risks.
Pradaxa and the RE-LY Safety Study
The RE-LY clinical trial was the cornerstone study that established Pradaxa’s safety compared to warfarin. It involved more than 18,000 people who used Pradaxa or warfarin. When the study was complete, doctors found the following rates of serious bleeding disorders:
- 16.4% of people taking Pradaxa experience bleeding
- 3.3% experience serious bleeding
- 1.5% experience life-threatening bleeding
- 0.3% experience life-threatening bleeding in the brain.
- 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding
Pradaxa Linked to Cerebral Hemorrhage Death
Recently, doctors from the University of Utah published a report in the Journal of Neurosurgery regarding the death of an 83 year-old patient who was taking Pradaxa. He had a minor fall in which he hit his head. When the man appeared in the emergency room, he was fully aware and could answer questions. The doctors performed a CT scan, which revealed a small area of bleeding in his brain. Unfortunately, because the man was taking Pradaxa, doctors could not stop the bleeding in his brain. Within hours, the man slipped into a coma and died.
Unlike Coumadin (warfarin), the only way to reverse the blood-thinning effects of Pradaxa is by mechanically removing it from the bloodstream with dialysis. However, by the time a doctor realizes that the patient needs dialysis, it may be too late. Dialysis takes two to three hours to remove 30-60% of Pradaxa from the bloodstream. By that time, a patient could easily bleed to death.
Pradaxa Side Effects
Other Pradaxa side effects include:
- Heart attack
- Hemorrhagic stroke
- Cerebral hemorrhage
- Internal bleeding
- Gastrointestinal bleeding
- Rectal bleeding
- Death
Do I have a Pradaxa Lawsuit?
The Schmidt Firm, PLLC is currently accepting Pradaxa injury cases in all 50 states. If you or somebody you know was injured by severe bleeding, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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