Patient Safety News: Questions linger about Xarelto clinical trials

As lawsuits continue to increase against the makers of the anti-clotting medication, Xarelto, attorneys around the U.S. say the drug never should have received approval from the Food and Drug Administration (FDA).

Xarelto was approved by the FDA in 2011 after a fast-track regulatory review despite the fact that some of the agency’s own scientists had concerns about its safety.

The BMJ, a medical journal based in the UK, recently published a paper that called into question the clinical trial for Xarelto, known as the Rocket-AF study. The BMJ paper noted that a device used during the clinical trial was faulty and was taken off the market in 2014 for giving false results. Other articles, including one in the Journal of the American College of Cardiology, have alleged multiple problems with the Rocket-AF study, including missing data.

“New questions are being raised about the clinical trial of a widely used heart drug, and critics are calling for an independent investigation, after a medical device used during the study was later found to be faulty and recalled,” CBS News reported.

More than 13 million Xarelto prescriptions have been written in the U.S., making it the most prescribed blood thinner in its class in the country, the report stated.

Susan Faunce, an attorney at Berman & Simmons who handles cases involving dangerous drugs and medical devices, is accepting clients in Maine who took Xarelto and suffered harm.

More than 6,000 plaintiffs nationwide have filed lawsuits against drugmakers Bayer and Janssen Pharmaceuticals. They claim that Xarelto causes uncontrolled internal bleeding and other serious health issues including stroke, pulmonary embolism, and brain hemorrhage. Many of these cases are being consolidated in federal court in the Eastern District of Louisiana. The first trials stemming from these lawsuits could be heard in 2017, but legal analysts expect plaintiffs to continue to file complaints for several years to come.