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The Institute for Safe Medicine Practices (ISMP) released its latest QuarterWatch report on May 7, 2014. In it, they revealed that the number of serious adverse event reports associated with Xarelto (rivaroxaban) now outnumber those from rival blood-thinning drug, Pradaxa (dabigatran).

The ISMP added that increasing prescriptions have something to do with it—the total increased to nearly one million per quarter for Xarelto, while those for Pradaxa have steadily declined since 2012. By the end of 2013, Xarelto prescriptions outnumbered those for Pradaxa by nearly two to one.

Whereas Pradaxa had been the anticoagulant of concern for the past several quarters, Xarelto has now become equally as concerning, with patients reporting excessive bleeding that is often life-threatening.

Earlier Report Indicates Risk of Xarelto Blood Clots

In an earlier 2012 QuarterWatch report (Q1), the ISMP noted a key difference between the adverse events reported for Xarelto compared to Pradaxa:

• Pradaxa cases usually involve hemorrhages in older patients with atrial fibrillation (median age 80).
• Most Xarelto cases involve the development of severe blood clots in younger patients (median age 66 years) taking the drug to reduce the risk of blood clots after hip or knee replacement surgery.

After the FDA approved Xarelto for use in reducing risk of post-operative blood clots, the drug has replaced warfarin and enoxaparin (Lovenox) in many hospitals. Venous and pulmonary (lung) clots have been reported, however—158 cases in the first quarter of 2012.

ISMP Questions Dose of Xarelto

Manufacturers Janssen Pharmaceuticals, parent company Johnson & Johnson (J&J), and Bayer Health Care have promoted Xarelto as being a more convenient option for patients. Unlike warfarin, it requires no blood monitoring or dietary changes, and comes in a once-daily dose. Those who have filed Xarelto lawsuits, however, claim the manufacturers failed to provide adequate warnings about the risks—that the drug could increase risk of the very blood clots it is meant to prevent.

In the QuarterWatch report for the second quarter of 2012, ISMP reported that warfarin, Pradaxa, and Xarelto accounted for 1,734 adverse event reports, including 233 deaths, “reinforcing the conclusion that anticoagulants rank among the highest risk of all outpatient drug treatments.” The report also noticed something surprising—blood-clot related events were reported more often with patients receiving the lowest 10 mg dose after knee or hip replacement surgery, as compared to the higher 20 mg dose taken by patients with non-valvular atrial fibrillation. ISMP noted, “This raises the concern whether the 10 mg dose is suboptimal.”

Injured Plaintiffs Filing Xarelto Lawsuits

Over 2,000 Pradaxa lawsuits are pending around the country, with all federal cases consolidated in the Southern District of Illinois. The first Xarelto lawsuits were filed in early 2014, and more plaintiffs are expected to join the litigation. Reuters reported in June that there were fewer than ten suits at the time, but several have been filed since then.

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