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Spangenberg Shibley & Liber LLP | Aug 8, 2015

Xarelto - A High-Risk Treatment Causing Uncontrollable Bleeding

Categories: Defective Drugs and Medical Devices

Xarelto (Rivaroxaban) is a once-a- day blood thinner prescription to prevent blood clots.. The Food and Drug Administration (FDA) approved Xarelto for use in patients who have had knee or hip replacement surgery to reduce the risk of blood clots, reduce the risk of stroke and as a general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

Xarelto, however, has been reported to cause uncontrollable bleeding that can lead to hospitalization and death. When bleeding occurs near a major organ, such as the brain, lungs or kidneys, it could cause it the organ to lose some or all of its functionality. Also, pools of blood may form within the body and can cause other severe health risks. Because Xarelto prevents clotting, the hemorrhaging will continue until the drug is flushed out of the system.

A study done by the British Medical Journal (BMJ), shows Xarelto is associated with a significant increase in risk of clinically relevant bleeding (relative risk 1.25, 95% confidence interval 1.05 to 1.49; P=0.01) The study also indicates that Xarelto will cause more major bleeding over all other outcomes among other warfarin alternatives.

Bayer and Johnson and Johnson’s subsidiary, Janssen Pharmaceuticals, market Xarelto the as providing the same or slightly better results than warfarin in preventing strokes and other blood clot-related events, despite the fact there is no known antidote that currently exists to reverse internal bleeding. Patients are spending about $3000 per year for Xarelto compared to $200 per year for warfarin and the drug does not require regular blood tests or monitoring. ( Also, unlike older anticoagulants that require doctors to prescribe specific doses for each individual, Xarelto belongs to a new type of oral anticoagulant that is prescribed in one uniform dose.

Some of Americas top heart doctors are concerned about Xarelto’s safety along with the financial hardship caused by emergency visits, ongoing care, and lost wages, emotion distress, increasing deaths linked to uncontrolled bleeding caused by Xarelto and holding Bayer and Janssen Pharmaceuticals accountable for releasing a dangerous drug. By the end of the 2012, the U.S. Food & Drug Administration (FDA) has received 2,081 reports of Xarelto complications, including 151 that resulted in death. (

A letter issued to the director of Johnson & Johnson from the FDA, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion stated Xarelto’s print ad in the 2013 WebMD magazine, as false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. The risk information was presented on the adjacent page without any emphasis, which fails to convey the risk information without reasonable readability comparable to the efficacy claims.

Read more at:

BMJ 2012;344:e3675 doi: 10.1136/bmj.e3675 (Published 14 June 2012)