FDA & British Medical Journal Disagree on Safety of Xarelto

Thursday, October 20, 2016
Xarelto Anticoagulant

There’s been much debate about the safety of the anticoagulant Xarelto since it first hit the market in 2011. Despite claims the drug is safer than traditional warfarin, studies and thousands of patient lawsuits suggest it can cause serious internal bleeding with greater chances of death.

Last year, reports surfaced that a key device used in the initial clinical trial testing of Xarelto was defective, calling into question whether the results were valid.

Now, the British Medical Journal and FDA have issued disagreeing opinions on whether the safety of Xarelto is in question, and whether manufacturers Bayer/Johnson & Johnson hid the problem.


Did J&J Hide Xarelto Safety Testing Defaults?

In 2015, reliability and accuracy issues were discovered with a blood-clotting measuring device known as the INRatio. Since the device was used extensively to compare the effectiveness of warfarin with Xarelto during the latter’s clinical trials, the results were called into question.

The manufacturers of Xarelto, Johnson & Johnson and Bayer, were quick to dispel concerns that the faulty device had any significant effect on the trial outcomes, or that they had any knowledge of the defects.

However, an investigation by the British Medical Journal now shows J&J knew about INRatio device defects as early as 2008 during an earlier trial, but didn’t notify testing authorities or the FDA of the concerns before Xarelto was approved.

The BMJ also found that Xarelto partner Bayer knew about INRatio problems during Xarelto testing, but didn’t know until recently that J&J learned of the defects as early as 2008.


FDA Backs Xarelto Despite Concealed Data

With questions swirling around the dependability of Xarelto’s clinical trials and the safety of the drug itself, the FDA issued a statement last week in an attempt to appease concerned consumers.

While the FDA admitted the defective INRatio clot measuring device would have resulted in subjects receiving higher doses of warfarin and did effect the reported test results, they stated that the discrepancy would have been “quite modest” and it is “very unlikely” that overall trial results would have been much different without the defect.

Last December, the European Medicines Agency issued a similar statement backing the Xarelto trial results.


Defective Data Comes Out in Xarelto Bleeding Lawsuits

The Xarelto safety testing defects came out in the midst of a massive consolidated litigation brought by thousands of patients alleging they had been hospitalized by severe internal bleeding while taking Xarelto. Many families have also filed suit over bleeding deaths suffered by loved ones.

So far, 12,185 Xarelto lawsuits have been filed in a federal multidistrict litigation court in the Eastern District of Louisiana under U.S. District Judge Eldon E. Fallon. The case is known as MDL -2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation.

With the first trial set to begin in the Spring, lawyers anticipate more troubling data will be presented questioning the safety of Xarelto and whether the manufacturers hid it from the public.

Lawyers are still helping those affected file claims, however the time to take action may be limited. For more information or to speak directly with a lawyer at no cost, contact DrugNews today.



Cohen, D. Manufacturer failed to disclose faulty device in rivaroxaban trial. British Medical Journal. (September 28, 2016). Retrieved from http://www.bmj.com/content/354/bmj.i5131

Helfand, C. Countering Xarelto critics, FDA backs clot buster's benefits despite study's faulty device. FiercePharma. (October 11, 2016). Retrieved from http://www.fiercepharma.com/pharma/fda-reconfirms-xarelto-s-benefit-after-faulty-device-use-study

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