Internal hemorrhaging is a life-threatening side effect of Pradaxa. There is growing concern over the safety of Pradaxa, especially for elderly people and those who have impaired renal function or kidney problems. Pradaxa is an anti-clotting drug, but in the event of injury, people who are taking Pradaxa may not be able to form the blood clots to stop life-threatening bleeding. In an emergency, doctors may be unable to stop internal hemorrhaging before a person bleeds to death.
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 a medication that prevents blood platelets from sticking together and forming blood clots. In 2010, the U.S. Food and Drug Administration (FDA) approved Pradaxa for people with atrial fibrillation, a type of irregular heartbeat that can cause blood clots to form in the heart. People with atrial fibrillation are at risk of ischemic stroke, or a stroke in the brain caused by a blood clot.
Millions of people have atrial fibrillation and take an anti-clotting medication to reduce the risk of stroke. The most popular anti-clotting medication is Coumadin (warfarin), which has been used since the 1950s. Warfarin is notoriously problematic and difficult to use, but its one great advantage over Pradaxa is that the effects of Warfarin can be reversed with a dose of Vitamin K.
Pradaxa has no quick reversal agent. Only 2-3 hours of dialysis can remove Pradaxa from the bloodstream. By the time dialysis takes effect, a person who is injured or requires emergency surgery could bleed to death.
Pradaxa and Internal Hemorrhaging
Before Pradaxa was approved by the FDA, researchers studied its safety in the RE-LY clinical trial. The trial showed that Pradaxa and Warfarin had comparable rates of bleeding. However, doctors in New Zealand expressed concern that most people in the RE-LY trial were younger than the people who typically experience major internal hemorrhaging. Furthermore, the New Zealand doctors were also concerned that people with low body weight, kidney problems, or renal problems are more likely to suffer major internal hemorrhaging. Therefore, the RE-LY study may under-estimate the actual number of people who suffer bleeding while taking Pradaxa.
The RE-LY study found the following rates of bleeding in Pradaxa 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
- According to doctors conducting the RE-LY study, Pradaxa carries a 6% risk of major internal hemorrhaging for every year of use
Symptoms of Internal Hemorrhaging
Internal hemorrhaging is life-threatening, especially for people who are taking Pradaxa. Because Pradaxa inhibits blood clots, even minor injuries can quickly become major internal hemorrhages. Recently, an 83 year-old Pradaxa patient died from internal hemorrhage after a minor fall. Bleeding inside the body can be difficult to diagnose, and some people may delay going to the hospital. Unfortunately, internal hemorrhaging can quickly become life-threatening. It is important to get to the hospital in time for dialysis to remove Pradaxa from the bloodstream.
Symptoms of internal hemorrhage include:
- Abdominal pain
- Abdominal swelling
- Chest pain
- Blood in the stool
- Blood in the urine
- Blood in vomit
- Blood in vagina (heavier than usual or after menopause)
- Skin color changes that occur several days after an injury
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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