Faulty Machine May Have Skewed Results in Xarelto Drug Trial

Once hailed for being a revolutionary way to fight blood clotting, Xarelto (rivaroxaban) now faces further scrutiny in light of new evidence that the FDA recalled a machine used during a pivotal trial for the drug.

Rivaroxaban was approved by the FDA in 2011 to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs. It is also used to treat a heart rhythm disorder known as atrial fibrillation, and to lower the risk of stroke caused by a blood clot. Now it is the subject of a mass tort lawsuit on behalf of patients who took the drug and suffered serious bleeding events.

The study in question compared Xarelto to the leading anti-coagulant prior to Xarelto, warfarin, and played a crucial role in getting Xarelto approved by the FDA. The trial included over 14, 000 patients and found that Xarelto was equal to warfarin in effectiveness, and that intracranial and fatal bleeding occurred slightly less often in the rivaroxaban group.

Having been proven equal to warfarin, and even slightly safer, Xarelto became the leading anti-coagulant immediately. Though effective, warfarin requires close monitoring as too much or too little can bring on devastating side effects. It also requires close monitoring of a person’s diet.

On the other hand, Xarelto is a low maintenance drug that is taken once a day, which provides a higher quality of life for a person in need of blood thinners.

However, it seems that Xarelto was always too good to be true.

A new investigation conducted by The BMJ, a medical journal based in the UK, found that a device used to test for blood clotting during the trial was recalled in December 2014 for giving false, low results.

The device maker confirmed to The BMJ that the problem dated back to 2002, wrote editor Dr. Deborah Cohen. The flawed device could have skewed the study results, making Xarelto seem safer than warfarin with respect to the risk of bleeding.

In response to the claims made by The BMJ, Duke University’s Clinical Research Institute, where the trial was carried out, published a letter in the New England Journal of Medicine stating that it had reviewed the results of the trial and continues to stand behind its results. The manufacturer of the drug, Janssen Pharmaceuticals, also issued a statement standing behind the product.

These newest allegations only add to the validity of claims that Xarelto may not be as safe as once thought. If you or a loved one suffered serious bleeding problems while taking Xarelto, the attorneys at Morgan & Morgan would like to hear from you. For more information on filing a lawsuit, contact us today for a free case review.

By Staff