Adverse Event Reporting for Xarelto

» Posted by on Aug 29, 2014 in Personal Injury | 0 comments

The Food and Drug Administration (FDA) gathers data on adverse events which in turn is monitored by consumer watch groups such as the Institute for Safe Medication Practices (ISMP) for information dissemination to the public. According to the ISMP publication QuarterWatch™ , the latest available data confirm that anticoagulant drugs are among the most dangerous of outpatient medications.

In the second quarter of 2012, Quarterwatch reported that the FDA logged 233 patient deaths out of 1,734 adverse event reports for three of the most popular blood thinning medications which including Xarelto. In the first quarter of 2013, 680 adverse events associated with Xarelto were reported, each of which may soon be a Xarelto lawsuit, outstripping its older rival Pradaxa, which logged 528 cases. The disparity is not a reflection on the higher risk associated with Xarelto but the increase in the number of patients. The numbers indicate that almost a million new prescriptions are logged every quarter for Xarelto while prescriptions for Pradaxa has steadily decreases since 2012. It is speculated that the ratio of Xarelto to Pradaxa may well be 2:1 by the end of 2013. The actual numbers are not yet in.

An analysis of cases in the earlier QuarterWatch report indicated that patients who are receiving low doses of Xarelto (10 mg) after knee or hip replacement surgery were at higher risk of blood clotting than patients with non-valvular atrial fibrillation who are put on 20 mg daily regimen. This indicates that the recommended dosage for post-surgical patients is not optimal, and that the touted efficacy of Xarelto may be exaggerated.

This has been the contention of some doctors, who are reluctant to prescribe Xarelto to their patients in light of the fact that the benefits of using the drug may not be enough to justify risking the adverse side effects associated with it. If you have been prescribed Xarelto and have discovered first hand and too late that it wasn’t worth the risk, consult with a Xarelto lawyer with proven experience in handling defective drug cases to find out what you can do to get compensation.

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