Article: Drugwatch - Pradaxa

Pradaxa 

More than half a century after the blood thinner warfarin was first sold in the United States, a major challenger has come on the scene. 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 has 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 is being blamed for more than 500 deaths. Patients and their families report instances of hemorrhaging and uncontrollable bleeding. Some are taking action against Boehringer Ingelheim by filing personal injury lawsuits.

Uses

For many years, warfarin — and its brand-name versions Coumadin and Jantoven — has been 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.

Pradaxa 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 ....  ===>

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