As Xarelto lawsuits move forward, new information about the clinical trials of the blood thinner is coming to light. At the heart of the controversy is a blood-testing device used during clinical trials that was later recalled for faulty results. While independent reviews of the clinical trials insist that the results were unchanged by the defective device, it now appears that some data wasn’t provided to the review panels.
Back up. What’s the story?
Xarelto belongs to a class of drug called anticoagulants. These drugs are used to prevent the formation of dangerous blood clots that can cause strokes, heart attacks and other life-threatening problems. Bayer and Johnson & Johnson developed Xarelto, also known as rivaroxaban, as a modern alternative to a 60-year-old drug called warfarin. The drug was quickly embraced for its ease of use; it is a once daily pill that requires no blood work or dietary restrictions, unlike warfarin.
However, the approval and use of Xarelto is controversial at best. The drug dissipates in the body quickly, meaning that the concentration of Xarelto in the body varies wildly over the course of a single day. Blood thinners can be extremely dangerous; too much or too little can cause life-threatening clots or uncontrolled bleeding.
Questions from the beginning
The controversy over Xarelto extends all the way back to the US Food & Drug Adminstration’s approval. The New York Times reports, “In 2011, the F.D.A.’s medical reviewers recommended against approval of Xarelto, citing concerns that the patients receiving warfarin during the trial were being poorly managed, which could give an unfair advantage to Xarelto. An outside advisory committee later voted to approve the drug — although several members cited reservations — and the agency allowed it to go on the market.”
According to CBS News, it now appears that, in addition to the FDA’s concerns, drug makers failed to provide access to blood tests that were processed internally during the clinical trials. If so, this could be another case of big pharma valuing dollars over lives. Is Xarelto safe? There’s no way to know until all of the information is available.
In the meantime, defective drugs and medical devices affect lives every day. Victims and their families can find their lives turned upside down by negligence and greed. At Rocky McElhaney Law Firm, we fight for your rights; we fight for you. For more information, visit one of our offices in Nashville, Gallatin, or Knoxville or contact us today for a free consultation.