Serious internal hemorrhaging is one of the most dangerous, life-threatening side effects of using Pradaxa. The risk may be even higher for older Americans, and also people with kidney problems, low body weight, or impaired renal function. Pradaxa is a new anti-blood clot medication, but when a Pradaxa patient is injured, they may be unable to create blood clots to stop internal hemorrhaging before they bleed to 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 an anti-clotting medication that prevents blood clots by inhibiting thrombin, an enzyme necessary for blood platelets to stick together. Pradaxa is created by Boehringer Ingelheim. It was approved for people with atrial fibrillation in 2010. People with atrial fibrillation suffer from periodic heart “flutters,” which can cause blood to pool in the heart and form blood clots. These blood clots can cause ischemic strokes in the brain.
Millions of people at risk of ischemic stroke take an anti-clotting medication. Coumadin (warfarin) has been in use since the 1950s, and is notoriously problematic. Warfarin interacts with many foods, has a high risk of bleeding, and required frequent blood tests to adjust dosage. Pradaxa was introduced to compete with warfarin. Pradaxa is a once-daily pill and is significantly easier to use than warfarin, but warfarin has one big advantage over Pradaxa: In case of an emergency, the effects of Warfarin can be reversed with a dose of Vitamin K.
Pradaxa has no fast reversal agent. The only way to stop the anti-clotting effects of Pradaxa is with dialysis, which takes several hours. By the time a doctor orders dialysis and it takes effect, a Pradaxa patient could potentially bleed to death from an internal hemorrhage, even from minor injuries.
Pradaxa and Internal Hemorrhage
Pradaxa triggers a 6% rate of major internal hemorrhage for every year of use, according to researchers who led the RE-LY clinical trial. This trial compared the safety and effectiveness of Pradaxa and Warfarin. It showed that they had comparable rates of bleeding and stroke-prevention. 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.
- 17.4% of people taking Pradaxa who needed emergency surgery experienced major bleeding
However, this information may not give an accurate picture of the actual risk. Doctors in New Zealand began receiving an alarming number of patients suffering from major internal hemorrhaging. The patients were mostly 75 years or older, had low body weight, impaired renal function, or impaired kidney function. The people in the RE-LY study were mostly younger and had no other complications. The doctors were concerned that the RE-LY data may be skewed in favor of the drug, when in reality, certain populations have a greater risk of major internal hemorrhaging.
Symptoms of Internal Hemorrhaging
Internal hemorrhaging can rapidly become life-threatening. It is particularly dangerous because it can be difficult to diagnose, which may cause people to delay going to the hospital. Unfortunately, Pradaxa patients who are bleeding internally must get to the hospital immediately to begin dialysis. Even minor injuries can quickly become life-threatening for Pradaxa patients. Recently, an 83 year-old Pradaxa user died from an internal hemorrhage he suffered after a minor fall.
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
Need a Pradaxa Lawyer in Texas?
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