What is Xarelto?
Xarelto is an anticoagulant, or blood thinner, sold by Bayer and Johnson & Johnson. The drug was initially approved to prevent stroke and reduce the risk of blood clots in patients who were having knee or hip replacement surgery. Shortly after, Xarelto was also approved for general treatment of deep vein thrombosis and pulmonary embolism. For decades, doctors have prescribed and adjusted anticoagulant dosages based on each patient’s specific health situation and monitoring the blood’s reaction to the prescribed medication. Xarelto allows doctors to prescribe one dosage amount that supposedly works for everyone and does not require blood monitoring. But without the blood monitoring, doctors often are not able to diagnose uncontrolled bleeding until it’s too late. For more than 50 years, Warfarin was the standard anticoagulant. Warfarin not only has less risk of bleeding but also, importantly, has an antidote to counteract the effects in case of emergency, such as a car accident. Xarelto does not have an antidote and cannot be flushed out of the body. If a patient experiences bleeding while on Xarelto, there is little that can be done to stop it immediately. In many cases the uncontrollable bleeding is fatal.

What are the Potential Injuries?
Xarelto is intended to thin the blood and prevent clotting but can cause severe, uncontrolled bleeding. The bleeding can interrupt the function of major organs and, in some instances, blood pools inside the body. With no way reverse the effects, many patients die.

Xarelto has numerous other reported side effects but some of the most dangerous, and potentially fatal, include:

• Abnormal liver function
• Brain hemorrhage
• Reduced platelet levels
• Internal or rectal bleeding
• Post-surgerical wound infections and leakage
• There is also evidence that Xarelto may actually cause some patients to have a higher risk of serious blood clots.

The Food and Drug Administration (FDA) has released a caution and refused to approve Xarelto for other uses but has not yet issued a mandatory recall.

Who makes Xarelto?
Xarelto (rivaroxaban) is a prescription anticoagulant, or blood-thinner, which has been sold in the United States since 2011. Xarelto was invented by Bayer Healthcare and then developed in conjunction with Johnson & Johnson. Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, licenses and manufacturers it for the U.S. market.

What does Xarelto do?
Xarelto prevents clots by blocking specific blood proteins that are essential for clotting.

What does the manufacturer say about Xarelto?
Janssen touts Xarelto as being just as good as Coumadin (warfarin) but without all the annoying lifestyle adjustments. Xarelto does not require frequent blood testing and can be taken just once a day. Additionally, there are no dietary restrictions while Coumadin requires patients to avoid Vitamin K rich foods.

Who takes Xarelto?
Xarelto is commonly prescribed to patients with atrial fibrillation, deep vein thrombosis (DVT), or pulmonary embolism (PE). Doctors also often prescribe Xarelto to prevent deep vein thrombosis or pulmonary emboli during joint replacement surgeries.

What are the dangerous side effects to Xarelto?
The most dangerous side effect is uncontrollable bleeding within the brain, abdomen, or rectum. This can lead to hospitalizations, transfusions, internal injury, and even death.

How is Xarelto different than Coumadin?
Janssen markets Xarelto as easier to use than Coumadin – just one pill a day with no monitoring. That’s the sales pitch. The downside is that there is no “off switch” for Xarelto; once you start bleeding it is impossible to reverse. You have to hope that Xarelto is flushed from your system before there is irreparable harm.

What does the Food & Drug Administration (FDA) say about Xarelto?
In June 2013 the FDA found that Xarelto’s advertisements made misleading claims and minimized the risks associated with taking Xarelto. Additionally, a February 2015 study published in the Journal of the American Medical Association noted that some drug manufacturers’ clinical studies significantly underreported negative events. One particular Xarelto study was deemed “unreliable” by the FDA after it was discovered that data had been altered and records had been thrown out.

Why does the manufacturer keep Xarelto on the market?
Janssen contends that Xarelto is safe – although the FDA states that Xarelto has the second highest safety-related complaints. Keep in mind that the worldwide market for blood thinning medications exceeds $10,000,000,000.00. In the United States alone, Xarelto is expected to bring in over a billion dollars – just this year.

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