Pradaxa Lawsuit

The drug Pradaxa (generic: dabigatran), prescribed to prevent strokes and atrial fibrillation, has caused hundreds of deaths worldwide, mostly among elderly people. Pradaxa side effects include severe internal bleeding, stroke, cerebral hemorrhage, rectal bleeding, heart attack, and more. Recently, an elderly man who was taking Pradaxa died after a minor fall. The man suffered minor bleeding in the brain, which doctors were unable to stop because Pradaxa prevents blood clotting. Unlike warfarin, Pradaxa has no antidote. Only dialysis can remove Pradaxa from the bloodstream. In an emergency situation, patients taking Pradaxa can easily bleed to death. If you were unaware of this risk and suffered a severe Pradaxa side effect, it is not your fault.

What You Can Do & How We Can Help

The Schmidt Firm, LLP is currently accepting Pradaxa induced injury cases in all 50 states. If you or somebody you know has been injured by Pradaxa, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Pradaxa Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Pradaxa Overview

Pradaxa (dabigatran) is a blood-thinning medicine created by the pharmaceutical company Boehringer Ingelheim Pharmaceuticals Inc. The U.S. Food and Drug Administration (FDA) approved Pradaxa in 2010 to prevent strokes associated with atrial fibrillation. People who have atrial fibrillation have occasional “fluttering” in the heart, which increases the risk that blood will pool in the heart, form a clot, and be pumped into the brain (causing an ischemic stroke). Pradaxa reduces the risk of ischemic strokes by inhibiting thrombin, an enzyme that is necessary for the formation of blood clots.

What is the problem with Pradaxa?

Pradaxa has no antidote.

Pradaxa was developed as an alternative to warfarin, a problematic medication that is difficult to administer and is inactivated by many foods containing Vitamin K. The one advantage of warfarin is that, in an emergency, a doctor can administer a simple dose of Vitamin K, which allows blood to clot and prevents bleeding to death.

Pradaxa has no antidote. When a Pradaxa patient needs emergency treatment, he or she must undergo dialysis to mechanically remove Pradaxa from the bloodstream. This can take several hours. By the time dialysis takes effect, a person can easily bleed to death — even from a minor injury. Recently, an elderly man who hit his head during a minor fall suffered a fatal cerebral hemorrhage.

Pradaxa Side Effects

Serious side effects of Pradaxa include:

Internal Bleeding is the most serious side effect of taking Pradaxa. The RE-LY clinical trial found that up to 16.4% of Pradaxa users may experience bleeding.
Gastrointestinal problems are also experienced by up to 35% of people taking Pradaxa. Problems may include indigestion, abdominal pain, ulcers of the digestive tract, black or tarry stools, gastroesophageal reflux disease, and more.

Other side effects may include:

Who has the greatest risk of serious Pradaxa bleeding? Doctors in New Zealand published a study which found that people who are over 80 years old, have impaired kidney function, and weigh less than 60 kg have the highest risk of severe Pradaxa bleeding.

Pradaxa & the RE-LY Clinical Trial

The Randomized Evaluation of Long-Term Anti-coagulation Therapy (RE-LY) was the cornerstone safety study that compared Pradaxa to warfarin.

Findings of the RE-LY Clinical Trial and 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.” According to Boehringer Ingelheim Pharmaceuticals Inc., 260 deaths have been caused by Pradaxa.

“Pradaxa triggers a 6% rate of major internal hemorrhages during each year of treatment,” said Dr. Michael D. Ezekowitz, a professor of medicine at Jefferson Medical College, Philadelphia, and one of the researchers who led the clinical trials during Pradaxa’s development.

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