Research shows the anticoagulant rivaroxaban—sold under the brand name Xarelto—might cause internal bleeding.
What Is Xarelto and What Is It Prescribed For?
Xarelto is the brand name for the drug rivaroxaban. Made by German pharmaceutical company Bayer AG and marketed in the United States by Janssen Pharmaceutica, a Johnson & Johnson subsidiary, this prescription medication is used to reduce blood clots in patients undergoing hip or knee replacement surgery. The U.S. Food and Drug Administration (FDA) first approved Xarelto in July 2011. Bayer sells it in oral doses of 10 mg taken daily.
One of the cheapest and most popular anticoagulants, which are often referred to as “blood thinners,” on the market is warfarin. Warfarin prevents platelets—the clotting agents in blood—from adhering to one another. Despite its low cost, doctors have difficulty finding the proper doses of warfarin for individuals. Too little, and it’s ineffective; too much, and it causes blood clots. Because of these difficulties, pharmaceutical companies try to find cheaper anticoagulants. Xarelto, Bayer and Janssen allegedly believe, promises to be that drug. Xarelto differs from warfarin because it is the first “direct factor Xa inhibitor.” Whereas warfarin prevents platelets from binding to one another, Xarelto supposedly interferes with the proteins involved in the chain reaction that allows blood to clot. Factor Xa is one of the proteins in the chain.
Although the FDA approved Xarelto for preventing pulmonary embolisms in joint replacement recipients, Bayer and Janssen have sought approval for atrial fibrillation, the medical term for an irregular heartbeat that causes strokes. In September 2011, the FDA advised against adding an atrial fibrillation indication to Xarelto’s drug label, pointing to the need for additional research. The agency based its decision on a study of 14,264 patients called the “Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation” (ROCKET-AF). The ROCKET-AF trial compared Xarelto to warfarin, and researchers could not determine Xarelto’s safety or effectiveness against warfarin. That study appears in the New England Journal of Medicine.
In June 2012, an FDA advisory panel voted against recommending that Xarelto’s allowable use be expanded to treating acute coronary syndrome along with two other drugs: aspirin and clopidogrel (Plavix). According to the New York Times, panel members were concerned about the risks involved in adding a third drug to a two-drug combination therapy.
Xarelto Might Cause Internal Bleeding Side Effects
The FDA delayed Xarelto’s approval for two years due to concerns that the drug causes potentially fatal internal bleeding. Examples include:
- Intracranial hemorrhages;
- Epidural hematoma;
- Gastrointestinal hemorrhages;
- Retinal hemorrhages; and
- Adrenal bleeding.
Xarelto’s label also contains a “black box” warning, the FDA’s most serious kind, alerting users and physicians that epidural or spinal hematomas in particular can be dangerous when patients receive neuraxial anesthesia or undergo spinal procedures while taking Xarelto. Epidural and spinal hematomas can cause paralysis.
RLG’s Xarelto Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Xarelto lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Xarelto lawsuit on your behalf if necessary. RLG will also keep you up to date on any Xarelto class action lawsuits, FDA Xarelto warnings, and Xarelto FDA recall announcements. If you have taken Xarelto and believe it harmed you, contact RLG today.