Pradaxa is a prescription anti-clotting medication used to prevent ischemic strokes, caused by blood clots that travel to the brain. Unfortunately, because Pradaxa inhibits blood clots, users may be unable to stop bleeding during an life-threatening emergency. Pradaxa may actually increase the risk of hemorrhagic strokes, which are caused by uncontrollable bleeding in the brain.
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 new type of anti-clotting medication. It is prescribed to people who have a high risk of ischemic stroke due to atrial fibrillation. Millions of Americans suffer from atrial fibrillation, a type of irregular heartbeat that can cause blood clots. These clots may travel to the brain and cause an ischemic stroke. People with atrial fibrillation take Pradaxa to prevent these strokes. Unfortunately, there is growing evidence that Pradaxa may actually increase the risk of another type of stroke — hemorrhagic stroke, or bleeding in the brain.
Pradaxa was developed by the drug company Boehringer Ingelheim, and it was approved by the U.S. Food and Drug Administration (FDA) in 2010. Since then, hundreds of people have died from bleeding caused by Pradaxa. However, the drug company argues that the death risk is no greater than with warfarin.
Pradaxa was developed as an alternative to warfarin (brand-name Coumadin), a medication that has been used since the 1950s. Unlike Pradaxa, which is a once-daily pill, warfarin requires frequent blood-testing to adjust dosage, has a high risk of bleeding, and interacts with Vitamin K (commonly found in green, leafy vegetables). The one benefit of warfarin is that its effects can be reversed with a simple dose of Vitamin K during an emergency, such as a hemorrhagic stroke. Pradaxa, on the other hand, has no such safety mechanism.
There is no efficient way to reverse the effects of Pradaxa. Only 2-3 hours of dialysis can remove Pradaxa from the body and reverse its blood-thinning effects. This can be particularly dangerous after an unexpected injury, such as head trauma after a fall. Minor bleeding in the brain may be unstoppable, leading to a hemorrhagic stroke and death. Pradaxa’s lack of a quick reversal agent can also be dangerous if a patient is in an unexpected accident and requires emergency surgery. The RE-LY clinical trial found that 17.4% of Pradaxa users suffered major, life-threatening bleeding when they had emergency surgery.
The risk of hemorrhagic stroke from Pradaxa was highlighted by doctors at the University of Utah, who published a report in Journal of Neurosurgery. The doctors treated an 83 year-old man who was using Pradaxa. Despite the doctors’ best effects, the man died of a hemorrhagic stroke after a minor fall. Because of Pradaxa, he suffered unstoppable bleeding in the brain. The doctors were concerned that the number of fall deaths would significantly increase as more and more people began using Pradaxa.
The only way to reverse the effects of Pradaxa is with dialysis. Unfortunately, dialysis takes several hours to remove 30-60% of Pradaxa from a patient’s body. By the time it takes effect, unstoppable bleeding in the brain can easily cause a hemorrhagic stroke.
Doctors in New Zealand have also become alarmed at the high risk of bleeding. They found that people who were over 75 years old who had impaired renal function were significantly more likely to suffer a major bleeding event.
A hemorrhagic stroke begins as a cerebral hemorrhage, or bleeding in the brain. The most common cause is head trauma that causes a traumatic brain injury. Among the elderly, head trauma from falls is the No. 1 cause of injury death. Nearly 50% of fall deaths are caused by head trauma.
During a hemorrhagic stroke, blood irritates brain tissue, causing it to swell. This is called “cerebral edema.” The pooling blood also forms a mass called a “hematoma.” Both cerebral edema and a hematoma cause significant increase in intracranial pressure, which inhibits blood-flow into healthy parts of the brain. As pressure increases, blood flow decreases, and brain tissue deprived of oxygen begins to die. Brain cells that come in contact with blood also die.
Brain damage from strokes is irreversible. People who suffer brain damage often have severe, permanent disabilities. The type of disability depends on what part of the brain was damaged. If the bleeding is not stopped, a person who suffers a hemorrhagic stroke will become comatose and die, usually within a few hours.
Symptoms of Hemorrhagic Stroke
The severity and type of symptoms will change depending on what part of the brain is bleeding and deprived of oxygen. Symptoms usually appear suddenly, but may grow worse with time as the bleeding becomes more wide-spread. If you suspect that you may be suffering a hemorrhagic stroke, seek emergency attention immediately.
Warning signs may include:
- Headache, pain
- Tingling in muscles, numbness in face, arms, leg, on one side of the body
- Weak muscles
- Becoming less alert, fainting, becoming drowsy
- Not able to answer simple questions
- Changes in taste, touch, hearing
- Problems speaking, slurred speech
- Vision becomes blurry, vision loss
- Problems with motor control — balance, walking, writing, swallowing
- Confusion, memory loss, inability to answer simple questions
- Personality changes
Pradaxa Side Effects
Other Pradaxa side effects include:
- Heart attack
- Hemorrhagic stroke
- Cerebral hemorrhage
- Internal bleeding
- Gastrointestinal bleeding
- Rectal bleeding
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