![]() ![]() It was on the market for less than five years before the antidote was introduced. It would have required more effort, but emergency room physicians would have been able to reverse it in the event of serious bleeding.Īccording to the United States Food and Drug Administration, adverse event reports for Pradaxa declined by almost 50% year over year after the launch of the blood thinner's antidote, Idarucizumab. Patients could have opted for the less convenient option of warfarin. Neither had an antidote at the time of initial drug approval, and both quickly racked up thousands of serious adverse event reports, including patient deaths. ![]() ![]() Pradaxa was launched in 2010, followed just shy of a year later by Xarelto. ![]() Pradaxa and Xarelto Were Launched Without Antidotes These positives seemed substantial enough for the FDA to initially approve the new generation of anticoagulants without antidotes. Patients could take them less frequently, and that would improve the rates of prescription compliance. They would not require constant monitoring and adjustment of dosages, nor would they have such a narrow effective range. Many regulators and physicians believed these newer drugs represented an overall improved safety profile. But newer drugs like Pradaxa and Xarelto were initially launched without antidotes, causing a number of serious bleeding events and deaths. Reversal agents for old-style blood thinners like warfarin and heparin have existed since the early 1900s. Current Anticoagulants Didn't Always Have Antidotesīlood thinners currently available in the United States have antidotes, but that wasn't always the case. They would have to weigh the advantages of decreased clotting and stroke with the small but real risk of experiencing a life-threatening bleeding event with no available remedy. Without a way to reverse the effects of anticoagulants, patients using the therapy would be left in a very precarious position. Though they can and do help many patients, anticoagulants can cause serious bleeding. Boarding & Prep School Sexual Abuse Lawsuitīlood thinners, or anticoagulants, interfere with the body's clotting mechanisms in an effort to decrease the risks of clot, stroke, embolism and deep vein thrombosis. ![]()
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