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Xarelto® Lawsuit Update: Kristine Kraft of Schlichter, Bogard & Denton, LLP Reports on Study Finding Bleeds Difficult to Stop for Some Anticoagulants, Including Xarelto®
Date:8/26/2014

YS5nb3YvZHJ1Z3NhdGZkYV9kb2NzL25kYS8yMDExLzAyMjQwNk9yaWcxczAwMFRPQy5jZm0=" onclick="linkClick(this.href)" rel="nofollow">Food and Drug Administration (FDA) in July 2011 for use in patients who recently underwent hip or knee replacement surgery to reduce the risk of blood clots. Use of the drug was later extended by the FDA for patients with atrial fibrillation (AF) to reduce the risk of stroke and for the general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

According to the Institute for Safe Medication Practices’ (ISMP) most recent Quarter Watch Report compiling data from 2013, Xarelto® (rivaroxaban) has overtaken Pradaxa® (dabigatran) in the number of reported adverse events, including serious bleeding events. The ISMP QuarterWatch reports that in 2013, the U.S. Food and Drug Administration (FDA) reported receiving 680 serious adverse event reports from individuals who alleged to have suffered adverse events while taking the anticoagulant drug Xarelto® (rivaroxaban), while only 528 serious adverse events were reported for Pradaxa® (dabigatran). The FDA’s Adverse Event Reporting System (FAERS) remains the cornerstone of postmarket safety surveillance, the mechanism through which most significant drug risks are detected once a drug has been approved and is available on the market.

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