Xarelto (rivaroxaban) is a medication that is commonly called a blood thinner or an anticoagulant. It came to the market in Oklahoma and across the United States in 2011, after FDA approval was granted. Today, it is widely prescribed for use in treating blood clot and stroke risk. In fact, it is now estimated that about 4 million Americans are using Xarelto each year. The drug is jointly manufactured by Bayer and Janssen Pharmaceuticals, and sales are reportedly approaching $1 billion on an annual basis.
Along with Pradaxa, Xarelto is one of a new class of blood thinners that are often prescribed instead of the traditional anticoagulant, Coumadin (warfarin). All blood thinners carry an increased risk of gastrointestinal or other internal bleeding. However, Xarelto side effects like internal hemorrhaging have generated claims of serious injury and even death.
Side Effects the Subject of Complaints
As the prescribed use of Xarelto expanded, reports of adverse events came into the U.S. Food and Drug Administration. In fact, in 2013, the federal agency reportedly received hundreds of such reports. Some of these reports relayed information about alleged incidents involving internal bleeding that caused permanent injury.
Two key issues are behind some of the complaints. First, some patients have asserted in lawsuits that they were not properly informed of the degree of risk of internal bleeding. Second, litigants have sometimes asserted that physicians were not able to bring episodes of internal bleeding under control due to the lack of an approved antidote that could reverse the anticoagulant nature of the medication.
When a physician detects internal bleeding in a patient on Coumadin, there is a protocol in place that seeks to reverse the anticoagulant nature of Coumadin through the use of Vitamin K. However, with Xarelto, there is no such approved reversing agent at this time. The joint manufacturers of the drug indicate that they are working with Portola Pharmaceuticals to develop such a substance, but it remains that no approved antidote to excessive bleeding has been available to physicians.
Problematic Xarelto side effects are now the subject of a growing number of civil lawsuits in Oklahoma and across the country. These suits typically seek monetary damages related to unpaid medical expenses, lost income, pain and suffering and possible long-term care. In instances where claims that death was allegedly caused by Xarelto side effects, surviving family members may seek compensation for pain and suffering, loss of consortium and burial expenses. Some litigants have requested in their court-filed complaints that Xarelto be recalled until an antidote is identified and approved.
Expanded Use of Xarelto Still Pursued by Manufacturers
Bayer and Janssen are continuing to seek other approved uses for Xarelto. For example, they have sought approval from the FDA in the past for the drug to be used to treat acute coronary syndrome (ACS). The FDA has previously refused to grant such approval, so the companies are proceeding with new clinical trials as they make their case for approved use of Xarelto across a wider portion of the population.
Injured Due to Xarelto Side Effects? Contact Us Today
Attorney Group for Oklahoma wants to help answer questions that you may have regarding Xarelto side effects and the lawsuits that have resulted. We can help you determine if you have a case in a free consultation, and if you decide to pursue a claim, we can connect you with an affiliated attorney. Contact us today to learn more.