What Is Pradaxa


The prescription blood-thinner Pradaxa was considered an upgrade from warfarin because it limited strokes. However, in May 2014 the manufacturer settled more than 4,000 lawsuits for $650 million.

More than half a century after the blood thinner warfarin was first sold in the United States, a major challenger arrived. Pradaxa (dabigatran), which was approved in October 2010, helps to prevent strokes, requires less maintenance than warfarin and is designed to have fewer side effects. After a year on the market, 16 percent of patients with atrial fibrillation (irregular heartbeat) were taking Pradaxa, compared with 44 percent who were taking warfarin. The remaining patients did not take medication. In late 2011, Xarelto (rivaroxaban) joined the anticoagulant market.By August 2012, more than 3.7 million U.S. patients had filled prescriptions for Pradaxa. In 2011, Boehringer Ingelheim, the German manufacturer of Pradaxa, spent $464 million to promote the drug, and it paid off. In the first quarter of 2012, worldwide sales reached $209 million. The anticoagulant therapy market is estimated to bring in $10 billion a year in the United States alone.Just two years after its arrival, however, Pradaxa was blamed for more than 500 deaths. Patients and their families report instances of hemorrhaging and uncontrollable bleeding. Some took action against Boehringer Ingelheim by filing personal-injury and product-liability lawsuits.The drug maker settled more than 4,000 of these claims in May 2014, agreeing to pay $650 millionto get rid of all existing multi-district litigations that were created. The company admitted no fault as part of the agreement and in fact pointed out that the benefits of Pradaxa far outweigh the negative side effects. It cited an FDA study of Medicare patients as proof.


For many years, warfarin — and 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 is another anticoagulant with a longer history, available since 1936, but it is not popular as it must be taken intravenously. Warfarin treatment can be difficult, as it requires regular doctor visits, blood tests and diet restrictions. In addition, side effects of warfarin can be debilitating, causing brain hemorrhages and other types of internal bleeding. A Duke University cardiologist noted that warfarin is one of the leading causes of emergency room fatalities in the United States.


PradaxaPradaxa and warfarin both treat patients with atrial fibrillation (AF) who do not have heart disease but are at risk for stroke and blood clots. In clinical trials, Pradaxa outperformed warfarin, reducing the risk of stroke more effectively than warfarin. Pradaxa is also easier to administer, as it does not have the strict requirements that come with warfarin. However, Pradaxa sells at a higher price and still causes some of the same side effects. Warfarin costs about $200 a year, while Pradaxa runs about $3,000 a year.

Warfarin and Pradaxa both prevent blood clots, but they function in different ways. Warfarin thins blood by decreasing the activity of vitamin K, which is essential to the chemical reaction that forms blood clots. Pradaxa inhibits the action of thrombin (a clotting protein) and is part of a drug class called direct thrombin inhibitors. The European Medicines Agency advises doctors to check a patient’s kidney function before prescribing Pradaxa.

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 Pradaxa or missing doses may increase the risk of stroke. Pradaxa is used to treat atrial fibrillation and venous thromboembolism.

Atrial Fibrillation

Atrial fibrillation (AF) affects more than 2 million Americans and occurs when the heartbeat becomes irregular, which can cause blood to pool in the upper chamber of the heart. It can cause chest pain, heart failure or stroke, which occurs when blood clots travel to the brain. People with AF are around five times more likely to have a stroke than those who do not. For some, AF only occurs occasionally and is not disruptive; for others, it can be a long-term heart problem with serious consequences.

Venous Thromboembolism (VTE)

In Europe and other countries, Pradaxa is used to prevent venous thromboembolism (VTE) following knee or hip replacement surgery. VTE is a lethal disorder that includes deep vein thrombosis (where blood clots form in a deep vein) and pulmonary embolism (where a blood clot in the veins travels to the lungs). The orthopedic procedure of knee or hip surgery puts patients at the highest risk category for developing VTE. Patients begin treatment one to four hours after surgery. Treatment usually lasts for 10 days for knee replacement and around a month for hip replacement.

VTE affects 1.5 million people and causes 500,000 deaths annually. In the 2012 American Heart Association Scientific Sessions, evidence was presented showing that Pradaxa was both safe and effective for VTE. The FDA has not approved this indication for Pradaxa, but Boehringer Ingelheim is in the process of conducting clinical trials to show the efficacy of Pradaxa for VTE. If this indication is approved in the United States , the number of Pradaxa users is expected to drastically increase.

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