Hundreds of people have died from serious internal bleeding after using Pradaxa, an anti-clotting medication that thousands of people use to prevent strokes. Unfortunately, people taking Pradaxa are unable to form blood clots when they start bleeding, which increases the risk of severe, life-threatening internal bleeding. There is growing evidence that people over 75 years old (especially those with impaired renal function or kidney problems) have a particularly high risk of major internal hemorrhages caused by Pradaxa.
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.
If you take Pradaxa (dabigatran), it is probably to reduce the risk of stroke caused by blood clots. In 2010, the U.S. Food and Drug Administration (FDA) expanded the approval of Pradaxa to include people who suffer from atrial fibrillation, a type of irregular heartbeat that can cause blood clots to form in the heart, which may then be pumped into the brain, causing an ischemic stroke.
Pradaxa is an anti-clotting medication. It prevents the formation of blood clots that could cause a stroke by inhibiting thrombin, an enzyme that causes blood platelets to stick together. Pradaxa reduces the risk of stroke by reducing the risk of blood clots. However, because blood clots are necessary to stop bleeding, all anti-clotting medications (including Pradaxa) increase the risk of serious internal bleeding.
Pradaxa and Serious Internal Bleeding
Pradaxa has caused at least 260 deaths worldwide from serious internal bleeding. Boehringer Ingelheim, the company responsible for Pradaxa, maintains that this number is no higher than was expected with data from the RE-LY clinical study.
When Pradaxa was going through clinical trials to determine its safety and effectiveness, it was compared to Coumadin (wafarin), an anti-clotting medication that has been in use since the 1950s. During the RE-LY safety study, researchers 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.
- 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
This risk of bleeding was comparable to warfarin, and the FDA decided to approve Pradaxa. However, there is one major difference between Pradaxa and warfarin: Pradaxa has no quick reversal mechanism. In an emergency, the anti-clotting effects of warfarin can be reversed with a simple dose of Vitamin K. However, with Pradaxa, the only way to reverse the anti-clotting effect is with dialysis, which can take several hours. By the time dialysis removes Pradaxa from the bloodstream, a patient can easily bleed to death.
Another concern with the RE-LY safety study was brought up by doctors in New Zealand who began receiving an alarming number of patients suffering from serious internal bleeding after taking Pradaxa. Most of the patients with major bleeds were older than 75 and had impaired renal or kidney function. Most of the patients in the RE-LY study were younger and had no complications. This suggests that some people may have a higher risk of serious internal bleeding, but doctors are prescribing Pradaxa to them anyway.
Internal bleeding is any type of bleeding that is inside the body. It is caused when blood vessels break and begin leaking blood into tissues, organs, or cavities in the body. Normally, the body has a good mechanism for stopping internal bleeding: It forms a blood clot, which seals off the broken vessel, and then it repairs the vessel. However, people who are taking an anti-clotting medication, such as Pradaxa, are unable to form the blood clots that would seal off the vessel. Pradaxa patients may suffer major internal bleeding, even from minor injuries.
Falling and Internal Bleeding
The risk of falling increases with age. Fall-related injuries (broken bones, head trauma, and bleeding) are the leading cause of injury deaths among older Americans. Elderly people are also more likely to suffer from atrial fibrillation and take Pradaxa. Unfortunately, the combination of falls and Pradaxa could be deadly.
Recently, an 83 year-old man died from serious internal bleeding that began after he hit his head in a minor fall. When he went to the hospital, doctors were unable to stop the bleeding because he was taking Pradaxa. Within six hours, the man slipped into a coma and died.
Symptoms of Internal Bleeding
Internal bleeding is often difficult to diagnose, because it may not have many symptoms at first. However, even minor internal bleeding can rapidly become life-threatening. Starting treatment as soon as possible is essential for survival. If internal bleeding is suspected, call 911 immediately. Do not wait.
Common symptoms of internal bleeding 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
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