Thursday, February 13, 2014

Clot Wars contd. - More than 2,000 Lawsuits Over Pradaxa Bleeding Risks, Boehringer Confirms

Boehringer Ingelheim, manufacturer of the blood-thinner Pradaxa (dabigatran), has confirmed that it faces more 2,000 lawsuits in the United States alleging that the drug causes severe and fatal bleeding.
The company’s confirmation came after the German newspaper Handelsblatt reported the number. Boehringer said that the company has to weigh the risk of known side effects against the drug’s life saving potential, according to Reuters. “We are certain that we can show in the legal cases that we have worked very carefully and responsibly in research, development and marketing of Pradaxa,” the German drug maker said in a written statement.
Pradaxa is one of a trio of new drugs – along with Xarelto (rivaroxaban), and Eliquis (apixaban) – competing to replace warfarin, a blood thinner in use since the 1950s to prevent strokes in patients suffering from atrial fibrillation, a form of irregular heartbeat common especially among the elderly. While cutting the risk of fatal or debilitating strokes, blood thinners increase the risk of internal bleeding, which can also prove fatal, according to Reuters.
Boehringer’s statement cited a recent study by the U.S. Food and Drug Administration (FDA) as showing that Pradaxa users ran a lower risk of severe bleeding than patients on warfarin, according to Reuters. The New York Times reports that since approval Pradaxa has been prescribed to 850,000 patients, but has also been linked to more than a thousand deaths. According to the Times, Pradaxa sales in 2012 totaled $1.5 billion.
Two weeks ago a federal judge unsealed documents revealing that Boehringer Ingelheim tried to quash an internal study for fear it would damage Pradaxa sales. Judge David Herndon, who released the documents, oversees many of the lawsuits alleging that the drug maker failed to properly warn about Pradaxa’s risks. A key point in Pradaxa’s marketing is that users are not subject to the inconvenience of regular blood tests, as warfarin users are. But the study findings suggested that many Pradaxa users do in fact need blood testing because metabolic differences, especially in older patients, may result in the individual having too little or too much of the drug in their bloodstream, meaning that the patient could be inadequately protected or face increased bleeding risks. This conclusion alarmed Boehringer executives and led to pressure to revise the paper or suppress it altogether.

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