Call Today for a FREE Confidential Case Review - Toll-Free 24/7 (866) 920-0753

Pradaxa and Serious Internal Bleeding

Pradaxa and Serious Internal Bleeding

More and more people are reporting serious internal bleeding after using Pradaxa, a new type of anti-clotting medication. Many of these people are elderly, suffer from kidney problems, or have impaired renal function. However, anyone who uses Pradaxa could suffer from serious internal bleeding, which is a potentially fatal Pradaxa side effect.

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

If you use Pradaxa (dabigatran), it is probably because you have atrial fibrillation and have a high risk of strokes caused by blood clots that form in your heart. The U.S. Food and Drug Administration (FDA) approved Pradaxa 2010 for people with atrial fibrillation. Pradaxa is an anti-clotting drug that inhibits thrombin, an enzyme that causes blood platelets to stick to each other.

Pradaxa is the first FDA-approved alternative to Warfarin, an anti-clotting drug that has been used since the 1950s. Like Pradaxa, Warfarin has a risk of serious internal bleeding. However, unlike Pradaxa, the anti-clotting effects of Warfarin can be reversed with a dose of Vitamin K. Pradaxa has no effective reversal agent. When a person using Pradaxa begins bleeding, it can be difficult or impossible for a physician to reverse the anti-clotting effects of Pradaxa before a person bleeds to death.

Pradaxa and Serious Internal Bleeding

Pradaxa has caused at least 260 deaths worldwide, but the pharmaceutical company responsible for Pradaxa says that the death-rate is equal to Warfarin, as determined by the RE-LY clinical safety study.

The RE-LY trial was the cornerstone safety study that compared Pradaxa to warfarin. In the study, researchers found the following rates of serious internal 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

Doctors in New Zealand expressed concern that the RE-LY safety study involved younger patients that are less likely to suffer serious internal bleeding. The doctors found that Pradaxa patients who were older than 75 who had low body weight, impaired renal function, or kidney problems were significantly more likely to suffer from serious internal bleeding. The FDA is also conducting a safety review of Pradaxa after receiving dozens of reports of serious bleeding linked to Pradaxa.

Internal Bleeding

Internal bleeding is a serious medical condition that occurs when there is bleeding in internal tissues, organs, or in cavities inside the body. It occurs when a blood vessel becomes damaged, usually after a traumatic injury. Internal bleeding can be difficult to diagnose, because symptoms may not appear for several hours after the bleeding begins. People taking anti-clotting medications like Pradaxa have a significantly higher risk of serious internal bleeding.

Usually, the body is pretty good at stopping internal bleeds. The body creates blood clots that stop blood flow, and then it repairs damaged blood vessels. However, when a person is taking an anti-clotting medication like Pradaxa, the body is unable to create blood clots and stop internal bleeding. People taking Pradaxa can suffer life-threatening internal bleeding even with relatively minor injuries or illnesses.

Falling and Internal Bleeding

Elderly people have a higher risk of falling. Bone fractures, head trauma, and bleeding are all very common injuries after a fall. Elderly people are also more likely to be taking Pradaxa to reduce the risk of stroke. Unfortunately, the combination of falls and Pradaxa is potentially life-threatening.

Recently, an 83 year-old man died from serious internal bleeding in his brain after a minor fall. The man was taking Pradaxa, which made it significantly more difficult for doctors to stop the bleeding. He would have needed dialysis to remove Pradaxa from his bloodstream, but dialysis takes 2-3 hours to remove 30-60% of Pradaxa from the body. By this time, an elderly person who is bleeding after a fall could easily bleed to death.

Symptoms of Internal Bleeding

Internal bleeding does not always show symptoms, and it may be difficult to diagnose. Serious internal bleeding can rapidly become life-threatening. If internal bleeding is suspected, this is an emergency situation and you should call 911 immediately. Do not wait.

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:

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.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

Free Case Evaluation

The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs’ law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm’s reputation for providing personal attention to each and every client we represent.

No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.

*
*
*