Questions about Xarelto Clinical Trials

There is a good chance that the millions of people watching this year’s Super Bowl will see a commercial for Xarelto. Xarelto, with a generic name rivaroxaban, is making hundreds of millions of dollars for Beyer and Janssen (a wholly owned Johnson & Johnson subsidiary), and these companies will take any chance they can get to increased sales.

untitled-1238929-mXarelto is a often called a blood thinning medication like Warfarin (Coumadin), which is its biggest competitor, but it is actually an anticoagulant. Xarelto serves the same purpose as a blood thinner, but workers differently. A blood thinner, as the name implies, thins a patient’s blood, and this makes it more difficult for blood clots to form. There is nothing wrong with clotting when we are talking about a cut that is bleeding. The human body produces platelets to form clots to stop bleeding when a laceration occurs.

However, when the clots form in the veins of a patient and block the flow of blood, this can lead to serious medical problems. If a clot blocks the flow of blood to the brain, it can cause a stroke, as the brain is not getting the oxygen it needs. If the clot forms in a deep vein of the leg (deep vein thrombosis or “DVTs”) the clot can break free and travel through the circulatory system causing tremendous damage. Not only can it restrict blood flow to the brain causing a stroke, it can make its way to the lungs, where it can puncture a hole known as a pulmonary embolism (PE), and this condition is often fatal.

While Warfarin has been proven effective at preventing these serious medical problems, it is important for doctors to closely monitor the dose, and this means a patient must get regular blood tests. A patient must also watch his or her diet very closely. When we say this, we are normally talking about losing weight, but in the case of Warfarin, the problem is vitamin K. If a person is taking Coumadin and eats too much vitamin K, a person may not be able to properly clot if he or she is injured, and that can be a serious problem. One of the biggest sources of vitamin K is leafy greens such as those found in salads.

Xarelto does not interact with vitamin K, so this should not be an issue. However, Xarelto has been shown to cause a serious and sometimes fatal internal bleeding disorder, including intracranial hemorrhage, and this has been the basis for many Xarelto injury lawsuits.

To make matters worse for the company, according to a recent news feature from CBS, increased clinical trials are required by the United States Food and Drug Administration (FDA) and were being performed until a piece of equipment used in the testing was recalled. It is not known how the test results are being affected by this piece of faulty equipment or even if they are affecting the test results, but it seems the safest thing to do would be to disregard the possibly compromised results and rerun all safety testing.

Call the Boston Jeffrey Glassman Injury Lawyers for a free and confidential appointment — (617) 777-7777.

Additional Resources:

Questions raised about clinical trial of popular heart drug, February 3, 2016, CBS News

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