Xarelto was first introduced in 2011, and sales of the medication are approaching $1 billion annually. It has been marketed as an alternative to Coumadin (warfarin), a traditional anticoagulant therapy.
Xarelto has been prescribed when physicians determine that anticoagulants are needed to treat medical conditions. As a direct thrombin inhibitor, Xarelto has been specifically formulated to reduce stroke and blood clot risk.
Reports of Uncontrollable Internal Bleeding
However, Xarelto has been reported to cause severe internal bleeding in some patients. The overall adverse Xarelto side effects being reported by those taking Xarelto (rivaroxaban) are leading to a growing number of lawsuits in New York and across the country. In 2013 alone, the Food and Drug Administration (FDA) received hundreds of reports of adverse events that occurred among those taking Xarelto.
One of the most-reported Xarelto side effects is serious hemorrhaging that cannot be controlled or reversed. This is a big problem because there is no approved antidote that physicians can turn to when hemorrhaging does occur. With Coumadin, there is an established protocol for controlling internal bleeding through the injection of vitamin K. With Xarelto, there is no known reversing agent that can slow or stop the drug’s blood-thinning capability.
Lawsuits Increasing in Number
As a result, a increasing number of lawsuits have been filed in New York and elsewhere alleging that severe or even fatal injuries have resulted from the use of the medication. Plaintiffs are seeking compensation for their injuries and losses. Some litigants have included demands that the drug be recalled until a proper antidote can be identified and approved by the FDA.
At the same time, Johnson & Johnson and Bayer are seeking FDA approvals to use Xarelto across a wider population. The two companies now want to see it used to treat patients diagnosed with acute coronary syndrome (ACS).
On three previous occasions, the FDA has rejected efforts to get approval for expanded use of the medication. The FDA has expressed concerns over bleeding risks when the agency rejected the requests. Despite this, Johnson & Johnson and Bayer have announced plans to proceed with three new clinical trials pertaining to the use of Xarelto in treating ACS. The two companies state that they are working with Portola Pharmaceuticals to develop a reversal agent or antidote. However, no such antidote has been identified or approved thus far.
Injured by Xarelto Side Effects?
Attorney Group for New York is available to answer your questions about Xarelto side effects and the lawsuits that have resulted. If you believe you have a case, we can connect you with an affiliated attorney who can assist you with the legal process. Find out more in a free consultation today.