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 Time...
Source: PharmaGossip - Category: Pharma Commentators Authors: Source Type: blogs