You may have seen Xarelto (rivaroxaban) advertised on television or in print media. Xarelto is one of the newest anticoagulants (blood thinners) on the market, and the U.S. Food and Drug Administration (FDA) approved it for use by patients following hip or knee replacement surgery to reduce the risk of blood clots and stroke; for the treatment of pulmonary embolism and deep vein thrombosis; and to reduce the risk of stroke and blood clots for those with atrial fibrillation.
Xarelto is a new type of oral anticoagulant that doctors can prescribe to patients in a single, uniform dose rather than in specific doses for each individual. According to Kantar Health, over $7 million was spent in print advertising for Xarelto in 2015, and in 2013, Xarelto was the top drug advertised in professional health journals.
However, the Office of Prescription Drug Promotions, an agency within the FDA, has not been happy with some of the advertising—specifically, an ad that was published in WebMD Magazine. The agency issued a letter about the ad stating its overall presentation was “misleading and minimized the risks associated with Xarelto.” Additionally, they claimed that a misleading statement maintained there were “no dosage adjustments” which conflicted with its product labeling that the dosage should be lowered for certain types of patients.
Alleged Side Effects of Xarelto
Since the introduction of Xarelto, there have been hundreds of reports suggesting a link between the drug and bleeding injuries and even death. Xarelto is considered part of a new generation of blood thinners that has been alleged to cause severe and potentially fatal side effects. These side effect include:
- Bleeding in the brain. Permanent disability or death can result from a patient who experiences a brain hemorrhage.
- Internal bleeding. This type of bleeding can lead to organ damage and death.
- Bleeding gums. A patient with bleeding gums may experience discomfort and serious dental problems.
- Coughing up blood. If a patient coughs up blood, it can indicate that he’s experiencing life-threatening bleeding.
- Paralysis. Losing movement and function of your limbs or torso can be life-altering.
- Retinal bleeding. A retinal bleed can cause serious damage to a patient’s eyesight. Depending on the amount of bleeding that occurs, that damage can be temporary or permanent, and a patient could lose his vision.
Uncontrolled bleeding is one of the most severe side effects of Xarelto. If bleeding takes place near a major organ—a kidney, lung, or brain—there’s interrupted blood flow and may cause loss of functionality of that organ. Additionally, blood pools can form in the body causing other serious health risks.
Currently, doctors have no antidote or way to prevent this serious side effect if a patient’s blood gets too thin after taking Xarelto. If a patient taking Coumadin (a popular, older anticoagulant also known as warfarin) has excess bleeding, vitamin K can be used to help reverse this. But vitamin K is not an antidote for Xarelto and will not work. So, unlike other blood thinners, Xarelto has no approved “reversal agent” or available medication that will stop uncontrolled bleeding.
Lawsuits Against Xarelto Manufacturers
Recently, some patients who believe they were injured by Xarelto have taken legal action against Bayer Healthcare who manufactures it and Johnson & Johnson’s subsidiary, Janssen, who markets the drug. Many of these claims allege that there was not adequate information given or warnings about the bleeding risks of Xarelto and its lack of an antidote. They also allege that the companies withheld this critical safety information. Additionally, the claims indicate that the drug was unreasonably dangerous and defective and the risks outweighed any benefits it might provide.
Those filing lawsuits against the manufacturers were seeking compensation for a variety of reasons, including:
- Emergency visits, lost wages, and continuous care created financial hardship
- Caring for loved ones who suffered medical problems due to Xarelto created emotional distress
- Funeral and burial costs of those who died as a result of uncontrolled bleeding needed to be covered
- Pharmaceutical companies should be held accountable for knowingly releasing a hazardous drug
If you or someone you loved suffered injuries from the potential life-threatening side effects of Xarelto, you may qualify for a lawsuit. Injury lawyers are evaluating whether patients who used Xarelto are eligible for compensation through a product liability lawsuit. Call us at 888-526-7616, or contact us through this website.