Pradaxa side effects may range from problems with ulcers to internal bleeding and even death. This medication is most commonly used in patients with atrial fibrillation, or an irregular heartbeat. This is because atrial fibrillation increases the risk of stroke, which is many times higher in patients with an irregular heartbeat. Pradaxa (dabigatran etexilate mesylate) is a prescription direct thrombin inhibitor anticoagulant, or blood-thinning medicine.

Pradaxa can reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. Pradaxa lowers the chance of blood clots forming in your body. It is prescribed to replace other blood thinners like warfarin (Coumadin), which is what's predominantly used in the United States to treat blood clots.

How is Pradaxa different than traditional blood thinners?

Pradaxa approval was given by the FDA for medical use on October 29, 2010. Pradaxa and warfarin work differently to help reduce the risk of stroke due to afib not caused by heart valve problems. Pradaxa is a direct thrombin inhibitor that helps to stop clots from forming by working directly on thrombin.Thrombin is the blood’s central clotting agent. Thrombin works by causing certain materials in your blood to bind together to form a clot.

Warfarin is a Vitamin K antagonist that helps to stop clots from forming by interfering with Vitamin K, a vitamin your body needs to form clots.

It wasn’t until October 2015 that Praxbind was introduced to the market as an antidote to the severe bleeding caused by Pradaxa. There is also no standard method to measure the anticoagulant effect of Pradaxa.

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Bleeding among serious Pradaxa side effects

Pradaxa can cause bleeding, which can be serious and sometimes lead to death. To find the best dose of Pradaxa for you, your doctor should test your kidney function before you take your first dose of Pradaxa, and, in some instances, each year after.

Pradaxa is being marketed as an improvement to traditional anticoagulants, such as warfarin for patients that require frequent blood draws. There have already been reports of 500 deaths and other serious, life-threatening Pradaxa side effects reported since it was approved by the FDA. There has only been one recall for Pradaxa, and this was for a specific lot of the medication. The FDA nor Boehringer Ingelheim, the maker of Pradaxa, have hinted that there is any reason to have Pradaxa recalled.

Symptoms of Pradaxa bleeding side effects may include:

  • Lethargy
  • Unusual bruising or bleeding
  • Pink or brown urine
  • Red or black tarry stools
  • Coughing up blood
  • Vomiting that resembles blood or coffee grounds
  • Headaches
  • Bleeding from the gums
  • Frequent nose bleeds
  • Weakness and swelling of hands, arms, lower legs, ankles, or feet
  • Joint pain or swelling
  • Dizziness
  • Death

Safety studies show dangers for patients with a variety of conditions

There have been two major studies of Pradaxa. The first, known as “RE-LY,” compared the safety and efficacy of the drug compared to warfarin in patients with atrial fibrillation. The drugs were found equally effective when 110 milligrams of Pradaxa was given, but Pradaxa was found superior to warfarin at 150 milligrams twice a day. At the higher dosage, unwanted bleeding occurred at about the same rate for both drugs.

The next study, called “RE-COVER,” compared Pradaxa to warfarin in patients with acute venous thromboembolism. In this condition, which involves blood clots forming in veins, patients taking Pradaxa suffered fewer minor bleeding events. An increase in dyspepsia, however, apparently led to a higher discontinuation rate for patients who had been taking Pradaxa.

Contact an attorney

If you or a loved one have suffered serious side effects of Pradaxa, Pradaxa injury, or death while using Pradaxa, you may be entitled to compensation. You need attorneys who understand the issues and have the experience to help you accurately assess your case options. Contact the Pradaxa lawyers of Ennis & Ennis, P.A. today for a free case evaluation. Our experienced Pradaxa attorneys can answer any questions you may have about Pradaxa litigation, Pradaxa side effects, a potential Pradaxa lawsuit, or even a possible Pradaxa class action lawsuit.


Nationwide Pradaxa Lawsuit Attorneys

Without seeking the help of a knowledgeable law firm, you may be left to suffer the side effects of Pradaxa without compensation. The attorneys at Ennis & Ennis want to help if you’ve been hurt by the side effects or someone you love has suffered from them. Set up a free initial case evaluation by filling out the form on this website or by calling our office.