Xarelto was introduced to the market in 2011 as an anticoagulant that was expected to replace Coumadin (warfarin) in situations where a reduction in the risk of stroke and blood clot was desired. Within just a few years’ time, an estimated 4 million people now use Xarelto annually. Sales of the drug are now approximately $1 billion per year.
Blood thinners such as Xarelto and Pradaxa do come with a stated risk of internal bleeding, hemorrhaging and other side effects. However, some have argued that the degree of risk inherent in these Xarelto side effects has not been adequately disclosed to patients, particularly since no approved reversing agent currently exists that can bring unwanted internal bleeding under control.
Adverse Outcomes Reported to FDA
In 2013 alone, the U.S. Food and Drug Administration (FDA) received hundreds of complaints from citizens in Iowa and other states regarding alleged Xarelto side effects. In some instances, the inability to bring internal hemorrhaging under control caused permanent injury or loss of life. For years, physicians prescribed Coumadin with the advance knowledge that, in the event of a bleeding problem, Vitamin K could be administered to reverse the anticoagulant effect of the drug.
However, the lack of a similar reversing agent that works with Xarelto has allegedly resulted in bleeding that could not be brought under control.
Unwanted Xarelto side effects like internal bleeding have led to the filing of an increasing number of lawsuits in Iowa and elsewhere across the country. Plaintiffs have sought compensation for unpaid medical expenses, lost wages, pain and suffering and long-term care. When the use of Xarelto is alleged to have caused a death, survivors have filed wrongful death litigation that may seek reimbursement for burial expenses and compensation for loss of consortium.
Some of the complainants have demanded in their suits that Xarelto be recalled until a proper antidote can be identified and subsequently approved by the FDA.
Expanded Use of Xarelto Sought
Even as the incidence of lawsuits is on the rise, Bayer Healthcare and Janssen Pharmaceuticals are seeking other approved uses for Xarelto that would actually expand its use across a wider population base. For example, the manufacturers now seek approval to use Xarelto in the treatment of ACS, or acute coronary syndrome. The FDA has rejected three previous requests to approve this expanded use of Xarelto. Nonetheless, the producers of the medication have initiated new clinical trials that seek to support the case for FDA approval once again. Previously, the FDA has indicated that excessive internal bleeding problems were one reason for the rejected requests.
Injured by Xarelto Side Effects?
Answers to your questions about Xarelto can be obtained by calling Attorney Group for Iowa. We can help you understand your options in your particular situation, and can connect you with an affiliated attorney if you decide to pursue a claim. Contact us today to learn more in a free consultation.