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Defective Device Used in Clinical Trials Adds to List of Concerns Over Xarelto Drug Safety

Posted on in Prescription Drugs

By Shawn Kasserman

clinical trials, Xarelto safety, Chicago product liability attorneysFrom the allegedly biased trials to supposedly hidden results, there is no shortage of issues surrounding Xarelto and how it came to be a mainstream drug. Unfortunately, the concerning information just keeps piling up; the most recent suggests that data may have been inaccurate due to the use of a defective international normalized radio device in the drug’s initial clinical trials.

U.S. Food and Drug Administration Reviews ROCKET AF Study Data

Last year, the European Medicines Agency began looking into the Bayer clinical trial known as ROCKET AF after one of the testing devices was recalled. The agency stated they were concerned about inaccuracies in the end results of tests used to compare clotting times in Warfarin and Xarelto participants. The U.S. Food and Drug Administration (FDA) shortly followed suit through a review of any and all relevant data.

Hemorrhaging Prevalent in Xarelto Lawsuits

The majority of lawsuits against the Xarelto manufacturers, Bayer, and Janssen Pharmaceuticals, relates to issues with hemorrhaging. Although a common issue in other anticoagulants (including Warfarin), it is possible that the recalled testing equipment could have concluded clotting times were equal or better in Xarelto participants than in Warfarin participants, even if they were not. This only adds to the already present concerns over just how safe Xarelto actually is.

A Sordid History for Xarelto

In 2011, FDA experts allegedly determined that clinical trials were biased to the point of favoring Xarelto over Warfarin. Then, as the drug began making its way into the mainstream, patients began to experience hemorrhaging in the brain, intestines, eyes, and other areas of the body. Liver damage was also raised as a concern.

But nothing seemed to surpass the concern that, despite having a risk of severe bleeding, no antidote was made or found to stop hemorrhaging once it started. This became a large part of the focus for those bringing lawsuits against Xarelto, with many posturing that they would have chosen a different drug, had they fully understood their risks.

Seeking Compensation for Your Xarelto Injuries

Tomasik Kotin Kasserman is working directly with victims injured or killed by Xarelto, and they are prepared to help with your claim. They have the skills, experience, and investigation skills needed to assist you in pursuit of justice and fair compensation. Schedule your free initial consultation with a skilled Chicago Xarelto lawsuit attorney and obtain the representation you deserve. Call 312-605-8800 today.

Source:

http://www.reuters.com/article/us-bayer-xarelto-idUSKBN0TR2DU20151209#gBetZ1eazeTRYerQ.97

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