![]() ![]() ![]() ![]() However, the approval of Praxbind as the first reversal agent available for any novel oral anticoagulant is likely to provide Pradaxa with a market advantage. “Today’s approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can’t be controlled.”Īlthough Pradaxa was the first to hit the market in 2010, it has become the weakest selling for the three drugs in recent years amid concerns about the risk of Pradaxa bleeding problems. “The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary,” Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the press release. However, there have been no such reversal agents available for Pradaxa, Xarelto or Eliquis. While the medications have been promoted as superior alternatives to warfarin for prevention of blood clots among patients with atrial fibrillation, and following hip and knee replacement surgery for at-risk populations, the medications have been linked to a large number of reported emergency bleeding problems, where doctors were unable to control hemorrhages, often resulting in serious injury or death.Īlthough all blood thinners carry a risk of bleeding events, users of warfarin can be given a dose of vitamin K to reduce the blood-thinning effects. ![]()
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