According to a July 9, 2014 report in the Digital Journal, the anticoagulant drug Xarelto has now surpassed Pradaxa in the number of reported adverse events, including serious bleeding events.
The Institute for Safe Medication Practices’ (ISMP) Quarter Watch publication reported that in 2013, the U.S. Food and Drug Administration received 680 serious adverse event reports from patients who alleged to have suffered adverse events while taking Xarelto, while 528 such events were reported by those taking Pradaxa.
Xarelto is manufactured by Bayer and marketed by Janssen Pharmaceuticals in the U.S., and was approved by the FDA in July 2011 for treatment to reduce the risk of blood clots in patients who undergo hip or knee replacement surgery. In November 2011, the FDA approved Xarelto for use in patients with atrial fibrillation to reduce their risk of stroke, and in 2012, Xarlto’s use was expanded again to include the general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
High Risk Treatment Option
Anticoagulant drugs are considered a high-risk treatment and cause bleeding in approximately 15 percent of those with atrial fibrillation. Nearly one million prescriptions for Xarelto have been dispensed per quarter in the U.S., and by the end of 2013, outnumbered those written for Pradaxa by nearly two to one. The ease of using Xarelto and Pradaxa have made them popular alternatives to warfarin.
According to ISMP, marketing Xarelto for ease of use, rather than providing tools to reduce bleeding risk, is a critical mistake and recommends that the FDA reconsider its decision to prohibit a lower dose of dabigatran that is recommended for older patients in almost all other advanced countries, and establish a therapeutic range so that plasma level tests can identify patients with excessive or less than desirable effects.
If you have suffered uncontrollable bleeding or if your loved one lost life due to bleeding after taking Xarelto we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced drug injury lawyers will work closely with you and fight to make things right.