Pradaxa is an anti-clotting drug that most people take to reduce their risk of ischemic stroke, a type of stroke that can be caused by a blood clot traveling to the brain. Unfortunately, there is growing evidence that Pradaxa may actually increase your risk of having another type of stroke — a hemorrhagic stroke, caused by uncontrollable bleeding in the brain.
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 new anti-clotting medication created by the pharmaceutical company Boehringer Ingelheim. It was approved by the U.S. Food and Drug Administration (FDA) in 2010.
Pradaxa is used by people who are at high risk of stroke caused by atrial fibrillation, a type of irregular heartbeat in which the upper chambers “flutter” ineffectively. These chambers to not effectively pump blood into the next chamber, leaving some left-over, which can pool and form blood clots. If these blood clots are pumped into the brain, they will cause an ischemic stroke.
Pradaxa was developed to compete with Coumadin (warfarin), an anti-clotting drug that has been widely-used since the 1950s. Warfarin is a very problematic medication, and causes large numbers of elderly hospitalizations every year. Patients must test their blood to adjust the dosage, and mistakes can cause severe bleeding. Warfarin is also inactivated by Vitamin K, commonly found in green, leafy vegetables. However, one advantage of warfarin is that it is very easy for a physician to administer a dose of Vitamin K during an emergency, when a patient needs their blood to clot.
Pradaxa in an Emergency
Because Pradaxa has no effective reversal agent besides dialysis, it can be difficult or impossible for a physician to stop life-threatening bleeding after an accident, or during emergency surgery. In fact, during the RE-LY safety study, 17.4% of Pradaxa patients who required emergency surgery suffered major, life-threatening bleeding.
In fact, if a doctor needs to stop bleeding during an emergency, the only option may be dialysis to remove Pradaxa. This can take several hours. By the time dialysis is complete, a patient could easily bleed to death or become permanently disabled.
This lack of a fast reversal agent is further complicated by the fact that emergency physicians may be unfamiliar with Pradaxa. Instead of ordering dialysis immediately, they may try traditional methods to stop bleeding, which do not work.
Pradaxa and Strokes
Although Pradaxa is intended to prevent ischemic strokes (strokes caused by blood clots), it may actually increase the risk of hemorrhagic strokes (strokes caused by uncontrollable bleeding in the brain).
A hemorrhagic stroke, also known as a “cerebral hemorrhage,” occurs when there is bleeding in the brain that permanently damages brain tissue. Brain hemorrhages can occur spontaneously, but are more commonly caused by head trauma. Recently, an 83 year-old man who was taking Pradaxa died after a minor fall in which he hit his head. Doctors were unable to stop a minor bleed in his brain, and the man died of a hemorrhagic stroke.
During a hemorrhagic stroke, an artery or blood vessel bursts and begins leaking blood into brain tissue, which kills brain cells. It also irritates brain tissue, causing it to swell (called “cerebral edema”). The blood may also form a mass called a hematoma, which further increases the intracranial pressure. This causes decreased blood flow to all areas of the brain, further exacerbating brain damage.
Head injuries after falls are the leading cause of injury death among elderly Americans. In fact, nearly 50% of fall deaths are caused by head trauma.
Deaths from Pradaxa
Boehringer Ingelheim, the pharmaceutical company responsible for Pradaxa, is already aware of hundreds of deaths worldwide caused by Pradaxa. These deaths were caused by severe internal bleeding. After 14 deaths from Pradaxa were reported in Japan, authorities issued a strong warning to doctors regarding the risk of bleeding. The FDA has also become concerned about reports of serious bleeding events links to Pradaxa.
Recently, a group of New Zealand doctors issued a study that found major problems with the way doctors were prescribing Pradaxa. They warned that people over 75 years of age who have impaired renal function may be at particularly high risk of serious, life-threatening bleeding.
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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