In 2011, Xarelto was brought to the marketplace and promoted as an alternative to Coumadin (warfarin) in certain situations when a patient in Colorado or elsewhere requires a blood thinner to address a medical condition. The FDA approved Xarelto to reduce risks associated with blood clots and stroke. The growth in the popularity of Xarelto among physicians has driven sales to almost $1 billion on an annual basis.
Incidents of Internal Bleeding
However, Xarelto (rivaroxaban) has been reported to cause internal bleeding in certain patients. Some lawsuits have alleged that patients were not adequately informed of this risk. Pradaxa, another anticoagulant, has also been the subject of litigation regarding internal bleeding. Xarelto side effects resulted in hundreds of complaints being forwarded to the Food and Drug Administration in 2013 alone.
A key controversy arose because there is thus far no approved antidote when Xarelto allegedly causes internal bleeding/hemorrhaging. With the traditional blood thinner Coumadin, physicians knew that Vitamin K could be administered to reverse adverse bleeding events. However, with Xarelto, potentially life-threatening hemorrhagic incidents can not be similarly addressed by a reversing agent. Serious injuries and death are alleged to have occurred as a result.
More Lawsuits Being Filed
Internal bleeding, hemorrhaging and other adverse Xarelto side effects have resulted in the filing of claims on behalf of affected patients and their families in Colorado and across the nation. In some of this litigation, plaintiffs have demanded the recall of Xarelto until a proper antidote can be developed and approved by the FDA. Injured parties have sought compensation for medical expenses, lost wages, permanent injury and pain and suffering. Survivors of deceased patients have sought compensation for burial expenses, loss of companionship and other losses.
More FDA Approvals Still Sought
At the same time, manufacturers of Xarelto are seeking additional FDA approvals so that Xarelto can be used across an even larger portion of the population. For example, three new clinical trials had been started to seek data to support its use in treating acute coronary syndrome (ACS). This effort has been initiated even though the FDA has turned down previous requests for approval of Xarelto’s use in ACS treatment. The FDA cited the risk of bleeding in explaining its rationale for refusing to approve the expanded use of the drug.
Have You Suffered from Xarelto Side Effects in Colorado?
Please contact us at Attorney Group for Colorado if you suffered injury after taking Xarelto. We can discuss your situation and help you determine if you have a claim. If you decide to pursue a claim, we can connect you with an affiliated attorney who can assist you throughout the legal process. Contact us today to learn more in a free consultation.