The controversy over Xarelto (rivaroxaban) continues after a recent article published in BMJ (formerly the British Medical Journal) questioned the validity of the data in Xarelto clinical trials.
The BMJ report from last month warns that a defective device used in clinical trials may have tainted the study data by underestimating the problems with Xarelto bleeding.
The device in question is the INRatio, manufactured by Alere, used in the ROCKET-AF clinical trials. These clinical trials compared rates of bleeding with Xarelto use and bleeding with Warfarin (Coumadin). The device was used to measure the amount of Warfarin present in research participants’ blood in an effort to monitor the dosing.
In December 2014, a recall of the INRatio was issued as a result of the discovery that some devices were producing artificially low results. The recall was issued after the manufacturer received nearly 19,000 reports of malfunctions from users, and 14 serious injuries reported as a result of the device malfunction.
The BMJ stated in the article that the Xarelto study raised serious concerns even before the INRatio recall was linked to the study. Many concerns focused on the patients’ use of Warfarin in the study that was used to obtain FDA approval for Xarelto.
“Even before the recall, the ROCKET-AF trial had been criticized for the relatively short time that participants taking warfarin were in the correct therapeutic range of the drug,” the BMJ declared. “The implication of the criticism was that patients’ use of warfarin was not adequately controlled, which, if correct, would have the effect of making rivaroxaban seem safer and more effective.”
Side Effects of Xarelto
Xarelto is an anticoagulant drug used to reduce the risk of stroke and blood clots in patients suffering from atrial fibrillation. It is a new generation anticoagulant and one of the three newer drugs used as an alternative to Warfarin, the most common anticoagulant drug used over the last 50 years.
The new anticoagulants were seen as superior to Warfarin in their reported ease of use and less monitoring required.
However, the side effects of Xarelto include serious complications that can be life-threatening and even fatal to users of the drug. One of the major side effects of Xarelto is uncontrollable internal bleeding, especially gastrointestinal bleeding and pulmonary bleeding.
Since the blood thinner is designed to inhibit the body’s natural clotting mechanism, patients who have a bleed may not be able to control it once it starts.
Unlike Warfarin, there has been no way to stop bleeding with Xarelto once it starts. Warfarin users who experienced bleeding were able to be administered fresh frozen plasma and vitamin K as an antidote to control the bleed.
One of the main problems with Xarelto is a lack of a reversal agent, so bleeds could continue indefinitely until the Xarelto is processed out of a patient’s system and the normal clotting function of the blood is restored.
Unfortunately for some, the uncontrollable bleeding with Xarelto led to permanent organ damage and even death. Similar uncontrolled bleeding concerns were seen with Pradaxa, another new generation anticoagulant, and the reversal agent Praxabind was released last October.
A reversal agent for Xarelto is currently in the works which can certainly help Xarelto users in the future, but for many, the problems with Xarelto left devastating effects.
Xarelto Lawsuit Information
In the federal court system, over 3,000 lawsuits are currently pending as part of a Xarelto multidistrict litigation. The Xarelto MDL trials are set to begin by August of this year.
If you or a loved one has suffered severe bleeding side effects of Xarelto, you may have a legal claim. A Xarelto lawyer can review your case at no additional charge to help you determine your legal options.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Xarelto attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Xarelto class action lawsuit is best for you. [In general, Xarelto lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
Get Help – It’s Free
Join a Free Xarelto Class Action Lawsuit Investigation
If you or a loved one took Xarelto (rivaroxaban) and suffered injuries such as uncontrollable internal bleeding, gastrointestinal bleeding, hemorrhaging, deep vein thrombosis or pulmonary embolism, you may have a legal claim. See if you qualify by filling out the short form below.
An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.
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