Pradaxa is a new type of blood-thinning medication that has recently been linked to severe bleeding disorders. Some of the most severe Pradaxa side effects include bleeding disorders, hemorrhagic stroke, cerebral hemorrhage, internal bleeding, heart attacks, and death. Even so, many people who take this medication are unaware of the severe risks.
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Pradaxa (dabigatran) is a new type of blood-thinning medication. It was developed by the pharmaceutical company Boehringer Ingelheim. It is the first in a new class of blood-thinners called direct thrombin inhibitors, which inhibit an enzyme called thrombin that is necessary for blood platelets to stick together. People taking Pradaxa have a lower risk of developing blood clots.
Pradaxa was initially approved for a very small population: those who had recently had hip or knee replacement surgery. In 2010, the U.S. Food and Drug Administration (FDA) significantly expanded Pradaxa’s approved usage. They approved Pradaxa for millions of people who suffer from atrial fibrillation, a type of irregular heartbeat that can cause blood clots to form in the heart, which could be pumped into the brain and cause an ischemic stroke.
Unfortunately, since thousands of people have started using Pradaxa, health authorities have received a startling number of adverse event reports.
Pradaxa Bleeding Deaths
In November 2011, the European Medicines Agency (EMA) announced that it was aware of at least 256 deaths that had been caused by serious bleeding in patients who were taking Pradaxa. In response, the EMA forced the drug company to update the labeling to warn of this risk. The U.S. FDA also announced that it would be conducting a new investigation of post-marketing side effects.
There have been at least 14 deaths in Japan, which have caused Japanese health authorities to issue strong warnings to doctors regarding the increased risk of fatal bleeds. Australian health authorities have also required Boehringer Ingelheim to update to safety label to warn of these risks. New Zealand doctors have also conducted a study that found Pradaxa risks were highest for people who were over 75 years old who had impaired renal function.
Bleeding Death From Fall Linked to Pradaxa
Early in 2012, three doctors at the University of Utah received an 83 year-old man who was on Pradaxa. The man fell, hit his head, and began bleeding slowly in his brian. When the doctors performed a CT scan, they found a small area of bleeding. They used traditional methods to stop the bleeding — giving intravenous fluids and proteins that encourage blood clots. However, because the man was taking Pradaxa, the doctors’ efforts were in vain. By the time the doctors realized that the only way to save his life was to put him on dialysis to removed Pradaxa from his bloodstream, it was too late. Dialysis would have taken several hours, and by that time, the man had suffered irreversible brain damage, slipped into a coma, and died.
The doctors were concerned that deaths from falls would increase as more and more elderly people begin taking Pradaxa. Even so, there are many elderly people who are using Pradaxa right now who have no idea that they may be at risk of a deadly cerebral hemorrhage after a fall.
The problem is that the only way to stop the blood-thinning effects of Pradaxa is with dialysis, which takes several hours. When a person suffers an unexpected injury and begins to bleed, it may be difficult or impossible for a doctor to stop the anti-clotting effects of Pradaxa before a patient bleeds to death.
Pradaxa and the RE-LY Safety Study
The cornerstone study that established Pradaxa’s safety and effectiveness was the RE-LY clinical trial, which involved 18,000 people who were either taking Pradaxa or Coumadin (warfarin).
When the study was complete, the doctors found the following rates of bleeding disorders in their patients:
- 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
The rates of bleeding were “comparable” to the rates with warfarin. Unfortunately, what is notable about this data is the rate of major bleeding in people who needed emergency surgery. The effects of warfarin can be reversed with a simple dose of Vitamin K in patients who need emergency surgery after an accident.
Pradaxa Side Effects
Other Pradaxa side effects include:
- Heart attack
- Hemorrhagic stroke
- Cerebral hemorrhage
- Internal bleeding
- Gastrointestinal bleeding
- Rectal bleeding
Need a Pradaxa Lawyer in Texas?
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