The makers of Xarelto (rivaroxaban), a top-selling anti-coagulant, have been under fire for allegations that the drug causes serious and often life-threatening internal bleeding.
Now, Janssen Pharmaceuticals and Bayer Healthcare, the makers of Xarelto, are facing more scrutiny after a new report emerged to cast doubt on the trials that indicated Xarelto was ever safe to use.
An investigation by the British Medical Journal suggests that there are concerns over the pharmaceutical trial used to approve Xarelto for American and European use.
The trial – named ROCKET-AF – was published in 2011 in the New England Journal of Medicine and compared Xarelto to an older anti-coagulant, warfarin. The test suggested that Xarelto is a safer and more effective alternative. However, the recent investigation has revealed that a blood clotting test device that was used in the trial was actually recalled in 2014 after delivering false test results. The investigators in the British Medical Journal concluded that the faulty device could’ve made the drug seem safer than it really was.
When asked, the makers of the device confirmed that the fault was known as far back as 2002.
Explaining Xarelto: Understanding the Harm
Xarelto is a new generation blood thinner that was approved on July 1, 2011 by the FDA for preventing deep vein thrombosis after knee and hip replacement surgery, as well as reducing the risk of systemic embolism and stroke in patients who have had non-valvular atrial fibrillation.
But Xarelto has been accused of causing harm through negative side effects, chiefly uncontrollable internal bleeding. The makers of the drug have been the subject of ongoing lawsuits stemming from complaints from a wide variety of patients about bleeding risk.
If you or someone you know has suffered as a result of taking Xarelto, contact a Xarelto lawyer at Hare Wynn today. Doing so is the only way to protect yourself and seek just compensation for the problems you or a loved one has faced as a result of taking the drug.