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Pradaxa Rectal Bleeding Lawsuit

Pradaxa Rectal Bleeding Lawsuit

Pradaxa has been linked to an increased risk of rectal bleeding which can be life-threatening. The risk of rectal bleeding may be particularly high for elderly Pradaxa users, because they are more likely to have impaired renal function and lower body weight, which makes the risk of over-dosage higher. Pradaxa has been linked to hundreds of deaths worldwide, from hemorrhagic stroke, heart attack, cerebral bleeding, falls, bleeding disorders, and more.

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

Pradaxa (dabigatran) is a new type of anti-clotting drug. It belongs to a class of drugs called direct thrombin inhibitors, which prevents blood clots by inhibiting an enzyme necessary for blood platelets to stick together. One major side effect of Pradaxa is major bleeding, including bleeding in the rectum.

Initially, Pradaxa was only approved for a small group of people — those who had recently had hip or knee replacement surgery, and had a high risk of developing blood clots that could cause a stroke. In 2010, the U.S. Food and Drug Administration (FDA) approved Pradaxa for people who suffer from atrial fibrillation, a type of irregular heartbeat that can form blood clots that could cause a stroke. Millions of people suffer from atrial fibrillation and could potentially take Pradaxa.

However, some experts are now saying that Pradaxa was rushed to market without enough forethought and planning. General practitioners were able to prescribe Pradaxa from day one without knowing how to prescribe it. Doctors prescribed Pradaxa to people over 75 years old who suffered from kidney impairment or poor renal function. Since then, dozens of elderly people have suffered major bleeding, and some have died.

Pradaxa and Rectal Bleeding

The Pradaxa medication guide lists “bleeding from the rectum” as a rare side effect of Pradaxa, but it may actually be quite common in elderly people. Many doctors are prescribing Pradaxa to elderly people with poor kidney function or impaired renal function, which significantly increases their risk of rectal bleeding. Rectal bleeding (known medically as “hematochezia”) refers to bleeding from the lower colon or rectum. The rectum is the last few inches of the large intestine.

The symptoms of rectal bleeding will appear as blood in the stools or on toilet paper. The color of the blood may be bright red, dark maroon, or a tarry color. Generally, the closer the bleeding is to the anus, the brighter red it will be. The amount of blood also varies, with some patients noticing only a few drops, or a brief passage of a couple tablespoons of blood. If the rectal bleeding is severe, the patient may pass bowel movements containing large amounts of blood.

If a person who is taking Pradaxa begins bleeding from the rectum, it may be difficult or impossible to stop this bleeding, because Pradaxa inhibits blood clotting. If you begin bleeding from the rectum while taking Pradaxa, this is an emergency situation.

Pradaxa in an Emergency

One major difference between Pradaxa and its alternative, Coumadin (warfarin), is that Pradaxa has no efficient reversal mechanism. What does this mean? If a person who is taking Pradaxa is injured and begins to bleed, a doctor may be unable to reverse the anti-clotting effects of Pradaxa to save the person from bleeding to death. Warfarin can be reversed with a simple dose of Vitamin K. The only way to remove Pradaxa is with dialysis, which takes 2-3 hours to remove 30-60% of Pradaxa from the bloodstream. By the time dialysis takes effect, it may be too late.

RE-LY Study of Pradaxa Bleeding

According to Dr. Michael D. Ezekowitz, one of the researchers who led clinical trials during Pradaxa’s development, “Pradaxa triggers a 6% rate of major internal hemorrhages during each year of treatment.”

The RE-LY clinical 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

The Pradaxa Medication Guide warns that: “Pradaxa can cause bleeding which can be serious, and sometimes lead to death.”

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.

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