Since it received FDA approval in 2011, Xarelto has been prescribed as an anticoagulant medication that can reduce the incidents of blood clots and stroke. It is estimated that over 4 million people now take Xarelto every year. Total sales of the drug are estimated to be about $1 billion.
The blood thinning medication has been widely used in situations where Coumadin (warfarin) was previously prescribed. It competes in the marketplace with another anticoagulant, Pradaxa. Lawsuits have been filed that claim that the risks of internal bleeding and other Xarelto side effects were not adequately communicated to patients.
In a Tennessee wrongful death lawsuit filed in 2014, two sons state that their father was prescribed Xarelto in May 2013. In August 2013, the man experienced an episode of uncontrolled bleeding that allegedly resulted in permanent injury. The man died suddenly on December 6, 2013, the suit states. The lawsuit alleges that Janssen Pharmaceuticals and Bayer Healthcare aggressively market the medication to consumers as easy-to-use and safe. The lawsuit further claims that the manufacturers understated the risks of internal bleeding.
Complaints Forwarded to FDA
The U.S. Food and Drug Administration (FDA) reported that, in 2013, it received several hundred complaints regarding undesirable Xarelto side effects. Some lawsuits have alleged that the absence of an approved antidote to internal bleeding has led to serious harm and even death. For years prior to the introduction of Xarelto, physicians prescribed Coumadin because they knew a reversing agent, Vitamin K, could effectively halt incidents of internal bleeding caused by that medication. Despite the fact that the manufacturers have discussed the development of an antidote with Portola Pharmaceuticals, no approved reversing agent yet exists.
When a Tennessee patient experiences harmful Xarelto side effects, he or she may consider litigation that seeks compensation for harm caused and for various losses. For example, a legal complaint filed in civil court may allege that compensation is appropriate under Tennessee law for medical expenses, lost wages, pain and suffering and/or long-term care. Wrongful death litigation may seek compensation for loss of companionship and other expenses and losses.
Some of those that have filed Xarelto lawsuits seek a recall of the drug until an approved antidote to internal bleeding becomes available.
Expanded Use of Xarelto Sought
Even as the number of lawsuits increases, the manufacturers of Xarelto are seeking FDA approval to use it in other ways. For example, approval is sought to use Xarelto to treat acute coronary syndrome (ACS). New clinical trials have been announced even though the FDA has turned down such requests three times in the past. In those rejections, the FDA cited excessive bleeding risk as one reason for not approving expanded use of Xarelto.
Injured From Xarelto Side Effects?
Should you have questions regarding your Xarelto use or consumption of the drug by a family member, contact Attorney Group for Tennessee. We can help address your concerns in a free consultation, and help you understand your options. If you decide to pursue a claim, we can also connect you with an affiliated attorney. Contact us today to learn more.