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They didn’t know — because the marketing materials didn’t tell them — that not only does Xarelto come with the side effect of possible severe internal bleeding events, unlike other blood thinners this one does not have an antidote. When a patient on Xarelto suddenly develops a bleed, it is a potentially fatal event.

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Many people need blood thinners to prevent blood clots after surgery or to treat certain medical conditions. While doctors have for years relied on Coumadin (warfarin) to treat patients at risk of blood clots, strokes and irregular heartbeat, that drug requires careful monitoring and an individualized prescription regimen. When Bayer developed Xarelto (rivaroxaban) and received FDA approval in 2011, doctors thought it would be more convenient for knee- and hip-replacement patients because it is a one-size-fits-all drug.

The Risks of Xarelto

Xarelto is an anticoagulant. It works by binding to a substance called factor Xa, which prevents the formation of thrombin, an enzyme essential to the formation of blood clots. Even minor bleeding — like a nosebleed or bleeding gums — can be dangerous for a patient on Xarelto. Other anticoagulant drugs have an antidote which can be administered to allow clotting — in the case of Coumadin, the antidote is Vitamin K. The developers of Xarelto have yet to identify an antidote, but still the drug is being prescribed to millions of unwitting patients.

Xarelto has been reported to have caused irreversible bleeding in the brain, the eye, the stomach, intestines, and other internal organs.

Some Patients at Highest Risk

Older patients are at an even more serious risk for injury and death due to Xarelto use. Their risk of falling is higher than that of younger people, and thus the bruising or cuts that could result from a fall become much more dangerous if they are on Xarelto. Additionally, many elderly people take NSAIDS (such as aspirin, Motrin, Advil) to help with arthritis pain. But a study published in the April 2014 Journal of Internal Medicine found that the risk of a major bleed (a bleed in the brain, or another vital organ, or requiring transfusion, or a bleed that was fatal) is 2 ½ times higher if a patient on an anticoagulant is also taking an NSAID.

Documenting the Dangers

The reports of adverse events connected to Xarelto have spurred investigations the world over. A German report blamed Xarelto for 130 deaths in 2012 and 2013. Health Canada has registered 1,100 reports of adverse effects from rivaroxaban.

In the U.S., the Institute for Safe Medication Practices (ISMP) reports that by 2013 more than 700 Xarelto-associated adverse event reports had been submitted to the FDA.

In 2013, Bayer made $1.3 billion in sales from the sales of Xarelto. As heavy marketing efforts continue, their profits will rise . . . and so will the numbers of patients harmed by this dangerous drug.

Xarelto Lawsuits

Many Xarelto victims are seeking redress in the courts — so many, in fact, that in December 2014 the United States Judicial Panel on Multidistrict Litigation approved consolidation of 21 actions and 30 potential tag-along actions which had been filed in 22 federal courts across the country — in Florida, Illinois, Kentucky, Louisiana, New York, Utah, Vermont and West Virginia.

All of these cases alleged that the “plaintiffs suffered severe bleeding or other injuries as a result of taking Xarelto (rivaroxaban) and that the defendants did not adequately warn prescribing physicians or consumers of the risks associated with Xarelto, including the potential for severe or fatal bleeding and the unavailability of a reversal agent to counteract Xarelto’s anticoagulation effects. Issues concerning the development, manufacture, regulatory approval, labeling, and marketing of Xarelto thus are common to all actions.” (December 12, 2014, Order transferring cases to the Eastern District of Louisiana for coordinated or consolidated pretrial proceedings) In just one month after the MDL was approved, the number of lawsuits had risen from 21 to 86.

Additionally, the Philadelphia County Court of Common Pleas created a mass tort program (MTP) in January 2015 to consolidate dozens of Xarelto cases filed in Pennsylvania state courts. Like the federal MDL cases, these have common issues about the drug maker’s failure to provide adequate warnings of the risk of uncontrollable bleeding and the lack of an effective antidote.

Has someone in your family been harmed by Xarelto?

PGMBM is a plaintiffs’ law firm focusing on fighting for the rights of patients harmed by dangerous drugs. We are currently investigating claims of uncontrollable bleeding caused by Xarelto. A lawsuit can provide monetary damages for patients and their families to compensate for:

  • The expense of emergency visits, medical treatment and ongoing care
  • Lost income
  • Emotional distress caused by a loved one’s suffering
  • Funeral expenses.

PGMBM has a track record of successfully litigating against the manufacturers and marketers of dangerous drugs. If you or your loved one was harmed by Xarelto, let us seek justice for you. For a free consultation, contact us online or call 1-888-348-6787.