If you take Pradaxa, you may be at risk of suffering a fatal cerebral hemorrhage — life-threatening bleeding in the brain that can cause brain damage, permanent disability, or death.
Need a Texas Pradaxa Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by severe bleeding, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Pradaxa (dabigatran) is a prescription medication created by the pharmaceutical company Boehringer Ingelheim. It was approved by the U.S. Food and Drug Administration (FDA) in 2011 to prevent strokes in people who suffer from atrial fibrillation.
Millions of Americans, especially older Americans, have a type of irregular heartbeat called atrial fibrillation. It occurs when the upper chambers of the heart (the “atria”) do not beat in sync with the lower chambers, and instead “flutter” ineffectively once in a while. This can lead to the formation of blood clots, because the “fluttering” does not effectively push all the blood into the next chamber. This left-over blood can coagulate and form a blood clot. Blood clots in the heart are very dangerous, because they can easily break loose. If the heart pumps the blood clot to the brain, it will become trapped in a small vessel, and cause an ischemic stroke.
Before Pradaxa was developed, most people took another anti-clotting drug called Coumadin (warfarin) to prevent strokes from atrial fibrillation. Warfarin has been used since the 1950s, and is notoriously problematic because the optimal dose varies. Patients must use frequent blood-testing to adjust dosage, they have a high risk of bleeding, and they cannot eat any foods containing Vitamin K. Though warfarin has many disadvantages, one advantage is that its anti-clotting effects can be reversed with a simple dose of Vitamin K. Pradaxa, on the other hand, has no reversal agent.
In the event of an emergency bleeding situation, a patient needs blood clots to survive. Pradaxa is a blood-thinner, which means that it inhibits the formation of blood clots. In an emergency, often the only way to stop bleeding is to reverse the effects of Pradaxa. Unfortunately, the only way for a doctor to remove Pradaxa from your body is to use dialysis, which can take several hours to clear 30-60% of Pradaxa from the bloodstream.
An emergency doctor may not immediately realize that a patient is on Pradaxa, because it is a relatively new drug. Doctors will typically use traditional methods to stop bleeding — giving intravenous fluids and clotting proteins. However, these methods are ineffective. By the time the doctor realizes that the patient is using Pradaxa and needs dialysis, it may be too late.
This effect is particularly dangerous for people who suffer falls, traumatic accidents, or require emergency surgery. During the RE-LY safety study, 17.4% of Pradaxa patients who needed emergency surgery had major bleeding.
What is a Cerebral Hemorrhage?
A cerebral hemorrhage is bleeding in the brain, also known as a “hemorrhagic stroke.” It occurs when a blood vessel or artery bursts, usually due to head trauma. The broken artery bleeds into the surrounding tissues, destroys brain cells, and causes permanent brain damage.
During a hemorrhagic stroke, blood in the brain irritates brain tissue. This causes the tissue to swell (cerebral edema) and increases pressure inside the skull. The pooling blood forms a mass called a hematoma, which further increases pressure, and shuts off vital blood flow to the brain. Deprived of oxygen-rich blood, brain tissue begins to die.
One of the most common causes of cerebral hemorrhage is traumatic brain injuries. In fact, the most common cause of injury death among elderly people is head trauma from falls. Almost 50% of fall deaths are due to head trauma.
Doctors are concerned that the number of fall deaths due to cerebral hemorrhage will rise as increasing numbers of elderly people use Pradaxa.
Death From Fall Linked to Pradaxa Cerebral Hemorrhage
Recently, three doctors from the University of Utah published a report in the Journal of Neurosurgery regarding the death of an 83 year-old man who was taking Pradaxa. The man had a minor fall and hit his head. When he arrived in the ER, he was alert and talking. The doctors ran a CT scan and found a small area of bleeding in his brain. However, the doctors were unable to stop the bleeding because the man was using Pradaxa, an anti-clotting drug with no effective reversal agent. Within six hours, the man lapsed into a coma, and died.
Pradaxa and the RE-LY Clinical Study
Before Pradaxa was approved, the drug company conducted the RE-LY clinical study to determine the risks and benefits of Pradaxa. The study found the following rates of bleeding:
- 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 (cerebral hemorrhage).
- 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding
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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