Xarelto (generic name: rivaroxaban) is a relatively new blood-thinning medication that was developed by Bayer and marketed in the United States by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Intended as an alternative to drugs like Coumadin (generic name: warfarin), Xarelto has been marketed since 2011 as a drug to prevent patients from suffering life-threatening blood clots. However, there are allegations that this drug is not as safe as the manufacturers claim, and lawsuits are beginning to pile up against Bayer and Janssen.
The Potential Dangers of Xarelto
The biggest danger of any blood thinner, including Xarelto, is the risk of uncontrolled bleeding. When on blood-thinning medications, even a small cut, scrape, or bump can turn into life-threatening complication, as the body may be unable to form a clot that would close the wound and stop the bleeding.
Not only is Xarelto subject to this complication, but it has a significant disadvantage versus the older, more common blood-thinning drugs such as warfarin: there is currently no antidote on the market. This means that if a user suffers from an uncontrolled bleed, there is no medicine available to counteract the effects of Xarelto, and it can quickly turn into a life-threatening or fatal situation.
Some of the dangers of an uncontrolled bleeding episode include the following:
- Epidural hematomas, or bleeding on the brain.
- Intracranial hemorrhaging.
- Stroke or CVA (cerebrovascular accident).
- Hemorrhaging in the stomach or bowels (gastrointestinal bleeding).
- Other internal bleeding.
- Frequent or unstoppable nosebleeds.
- Excess bleeding from cuts or other injuries.
Xarelto has also been linked to a rare condition called Stevens-Johnson Syndrome or “toxic epidermal necrolysis,” a painful and life-threatening condition that causes the outer layer of the skin (epidermis) to slough off from the layer underneath (dermis) over large areas of the body.
Xarelto FDA Warnings and Investigations
The United States Food and Drug Administration (FDA) released a letter of warning to Johnson & Johnson in June 2013, indicating that the company’s advertising was “false or misleading” due to minimizing the risks associated with the drug. The FDA also took J&J to task for making a misleading claim about dosage adjustments. In 2013, the FDA also mandated a “black box” warning for Xarelto about an increased risk of blood clots if Xarelto therapy is stopped abruptly.
In 2014, the FDA required the manufacturer to add a notice about the lack of an antidote to Xarelto’s insert; later in the year, it also required that the risk of thrombocytopenia (low platelet count) and hepatitis (liver disease) to be mentioned.
In late 2016, the BMJ (formerly the British Medical Journal) published a shocking report that J&J used and knew about a faulty medical device used during clinical trials of Xarelto that could have affected outcomes of the trials and compromised patient safety, yet withheld this information from the FDA.
Xarelto Lawsuits and Multi-District Litigation (MDL)
Patients who were prescribed Xarelto and suffered from uncontrollable or irreversible bleeding—as well as the families of those who have died—have begun to file suit against J&J and Janssen Pharmaceuticals, seeking compensation for medical bills, injuries, and other costs allegedly caused by taking this drug. To date, thousands of lawsuits have been filed, alleging that the company failed to warn patients and doctors of the risks of uncontrolled bleeding. The plaintiffs claim that the company misrepresented the drug’s safety and continued to sell the drug even while knowing that it carried risks beyond what was publicly stated. In late 2014, Xarelto lawsuits were brought together—a process called multi-district litigation (MDL)—and bellwether cases are expected to be tried throughout 2017. The outcomes of these early trials will shape the way for future Xarelto lawsuits.
Get Legal Help With Xarelto Injuries
Have you been injured or suffered the loss of a loved one due to Xarelto? If so, Wayne Wright LLP would like to hear from you. We take pride in standing up against big drug companies who disregard the rights of patients by peddling dangerous drugs that cause more harm than good. If you’d like to talk to an experienced legal professional in Texas about your potential claim to compensation due to Xarelto, call us today at 800-237-3334 for a free, no-obligation case evaluation.