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Did Pradaxa Cause Serious Medical Complications?


Pradaxa is a prescription blood-thinner. It was approved in October 2010 and became a major competitor to the blood thinner warfarin. Pradaxa, as compared to warfarin, better helps to prevent stroke, requires less maintenance than warfarin, and is designed to have fewer side effects.

Pradaxa is used to treat atrial fibrillation and venous thromboembolism, explained below. Pradaxa is administered in 75 and 150 mg capsules, with most people taking 150 mg capsules twice a day. People with kidney problems may take lower doses. Suddenly discontinuing or missing doses of Pradaxa may increase the risk of stroke; Pradaxa can also cause serious injuries such as heart attack, hemorrhaging in the brain, or even death.

Weinstein Couture is currently investigating and taking on Pradaxa cases. If you or a loved one has taken Pradaxa and has suffered from uncontrolled bleeding, heart attack, liver failure, or death, please contact the attorneys at Weinstein Couture today at 800-406-1690 for a free case evaluation. Our attorneys will discuss your medical history with you to see if a lawsuit is the right option.

Atrial Fibrillation (AF)

Normal | Atrial Fibrillation

Atrial fibrillation (AF) is an irregular and often rapid heart rate that affects over 2 million Americans. During AF, the heart's two upper chambers (the atria) beat chaotically and irregularly-out of coordination with the two lower chambers (the ventricles) of the heart. As a result, the heart's upper and lower chambers do not work together as they should. For some, AF is not disruptive and occurs only occasionally; for others, it can be a long-term problem with serious consequences.

Atrial fibrillation can lead to blood clots forming in the heart that may circulate to other organs and lead to blocked blood flow. In those instances, AF can cause chest pain, heart failure, or stroke-if the blood clots travel to the brain. People with AF are approximately five times more likely to have a stroke than those who do not.

Venous Thromboembolism (VTE)

Venous thromboembolism (VTE) is a blood clot in the vein. Blood clots form when something slows or changes the flow of blood in the veins. These clots can form in, or travel to, arteries or veins in the brain, heart, kidneys, lungs, and limbs. They can cause heart attack, stroke, damage to the body's organs, or even death.

VTE is related to two life-threatening conditions: deep vein thrombosis (DVT) and pulmonary embolism (PE). Deep vein thrombosis is a clot in a deep vein, usually the leg. Pulmonary embolism is a DVT clot that breaks free from a vein wall, travels to the lungs, and blocks some or all of the blood supply. Typically, blood clots in the thigh are more likely to break off and travel to the lungs than blood clots in other parts of the body.

In some countries, Pradaxa is used to prevent VTE following knee or hip replacement surgery. Patients begin treatment one to four hours after surgery; treatment usually lasts for 10-30 days depending on the surgery. The FDA has not yet approved Pradaxa as a safe and effective drug for VTE, but Boehringer Ingelheim is currently conducting clinical trials to show Pradaxa's efficacy for VTE. If this indication is approved in the United States, the number of Pradaxa users will likely increase dramatically.

Pradaxa's Brief History

For many years, warfarin (or its brand-name versions, Coumadin and Jantoven) was the standard anticoagulant treatment for patients at risk for strokes and other conditions caused by blood clots. Heparin has also been available since 1936, but has not been as popular because it must be taken intravenously.

Warfarin treatment requires regular doctor visits, blood tests, and diet restrictions, and in some cases causes debilitating side effects. Like Pradaxa, warfarin treats patients with atrial fibrillation (irregular heartbeat) who do not have heart disease, but are at risk for stroke and blood clots. In its clinical trials, Pradaxa outperformed warfarin-reducing the risk of stroke more effectively. Pradaxa also is easier to administer and does not have the same strict requirements that comes with warfarin. However, Pradaxa is noticeably more expensive: Warfarin costs about $200 per year, while Pradaxa costs approximately $3,000 per year.

Unlike warfarin, which decreases the activity of vitamin K, Pradaxa works by inhibiting the action of thrombin (a clotting protein) and is part of a drug class called direct thrombin inhibitors. The Europena Medicines Agency advises doctors to check a patient's kidney function before prescribing Pradaxa.

Pradaxa's Presence In The Market

After just one year on the market, 16% of patients with atrial fibrillation (irregular heartbeat) were taking Pradaxa, compared with 44% who were taking warfarin. The remaining patients did not take any blood-thinner medication. In late 2011, Xarelto (rivaroxaban) joined the anticoagulant party.

In 2011, the German manufacturer of Pradaxa, Boehringer Ingelheim, spent $464 million to promote the drug. Their marketing paid off. In the first quarter of 2012, worldwide sales reached $209 million. By August 2012, more than 3.7 million U.S. patients had filled prescriptions for Pradaxa. The anticoagulant therapy market is estimated to bring in $10 billion per year just in the United States.

Just two years after its arrival on the market, however, Pradaxa was blamed for more than 500 deaths. Patients and their families report instances of hemorrhaging and uncontrollable bleeding. Some families took action by filing personal injury and product liability lawsuits against Boehringer Ingelheim. In May 2014, the drug maker settled more than 4,000 of these claims in order to get rid of the multi-district litigations that had been created. The drug maker admitted no fault as part of the agreement, yet agreed to pay $650 million to settle these claims.

Common Side Effects

Side effects for most people taking Pradaxa are generally minimal, which can deceive consumers into thinking this is a safe drug. The common side effects include indigestion, nausea, stomach pain, and heartburn. The risk of bleeding is highest in people 75 or older; people with kidney problems; or people with recent or recurring stomach or intestinal bleeding.

Serious Side Effects

In addition to the common side effects, Pradaxa's more serious side effects include uncontrolled bleeding, heart attack, liver failure, and even death. The most frequently reported serious side effect was bleeding, which can cause death and hemorrhages in the brain and central nervous system (which can be just as detrimental as stroke).

Patients should speak to their doctor immediately if they experience any of the following while taking Pradaxa:

  • Bleeding
  • Unusual bruising
  • Coughing up blood
  • Pink or brown urine
  • Headaches, dizziness or weakness
  • Unusual bruising
  • Vomit that resembles coffee grounds
  • Swelling or joint pain

In 2011, the FDA received 817 reports of adverse events involving Pradaxa. According to the nonprofit Institute of Safe Medication Practices' publication, QuarterWatch, Pradaxa was one of the most frequently mentioned drugs in the FDA's database of adverse event reports for 2011. Additionally, QuarterWatch gathered reports from manufacturers, databases, and medical professionals documenting 3,781 serious adverse events from Pradaxa in 2011; 542 of those events were fatal.

Please contact the attorneys at Weinstein Couture today at 800-406-1690 or by filling out the form on this page for a free case evaluation.