Although Xarelto comes with a number of warnings as to its side effects, internal bleeding is the most serious one. If it’s not detected in time, internal bleeding can lead to death. Plaintiffs who have filed lawsuits against Bayer claim that the company did not adequately warn people of this risk.
Xarelto (rivaroxaban) is prescribed by doctors to patients in order to reduce the risk of blood clots and strokes. Xarelto, unlike warfarin, is more accessible in that it doesn’t require blood tests to determine the dosage a patient should take. With Xarelto, a single one-size-fits-all dose is effective. Produced by Bayer and sold by Johnson & Johnson’s Janssen Pharmaceuticals, the drug was first approved by the FDA on Jul. 1 2011 for prevention of deep vein thrombosis in patients who had undergone knee or hip replacement surgery. Later that year and once more the following year, the FDA extended the use of Xarelto as a drug to reduce blood clots, pulmonary embolism and the risk of stroke in people who had abnormal heart rhythm (non-valvular atrial fibrillation).
It is estimated that Bayer made an estimate $1.3 billion from the sale of Xarelto in 2013 alone.
The manufacturer advertises the drug as a safe and more accessible alternative to warfarin but lawsuits filed against Bayer and J&J claim that they did not adequately warn people about the risk of internal bleeding. Another claim is that the manufacturer did not warn people of the fact that there is no antidote to the uncontrolled bleeding that Xarelto causes. The manufacturer has yet to release any medical information on how to stop uncontrolled bleeding.
The older anticoagulant warfarin, while still possessing an increased risk of bleeding, had a vitamin K antidote that could be administered by doctors in the ER. People who had to be hospitalized because of severe and even fatal bleeding as a result of taking Xarelto have filed lawsuits against Bayer, claiming that the company misled the public about the drug’s safety while recklessly putting a defective product on the market.
Free Xarelto Case Review
If you took Xarelto and suffered serious side effects such as internal bleeding or pulmonary embolism, you may have legal recourse. Contact us at 877-725-6839 or fill out the form on the right and one of our experienced attorneys will get back to you. We offer a free case review with no further obligation.
How does Xarelto increase the risk of bleeding?
Because the drug inhibits a certain protein which interrupts the blood clotting process there is the possibility that an injury, no matter how minor, can quickly lead to uncontrollable bleeding. Blood thinning medication works by inhibiting certain proteins in the blood in order to prevent the clotting process.
For Xarelto to be flushed out of the system, 24 to 48 hours must pass. Older people may have difficulty flushing the drug, extending the period the drug remains in their blood and thus prolonging the anti-coagulation effect. Seniors are more at risk than any other category of people for fatal bleeding, especially if they suffer an injury as a result of falling or hitting their heads.
Because Xarelto has no antidote, conventional methods of stopping the bleeding are useless, significantly increasing the risk of fatality. Some doctors will outright refuse to prescribe Xarelto because of this. Other types of bleeding caused by Xarelto are:
- Bleeding in the brain
- Rectum bleeding
- Stomach or intestinal bleeding
Patients who are preparing for surgery must stop intake of Xarelto at least 24 hours before procedure to avoid any complications. In addition to this, pregnant women may face serious complications if they take Xarelto such as hemorrhaging.
A study published in the New Journal of Medicine has found that while Xarelto caused less bleeding the brain than warfarin, it increased the risk of abdominal bleeding.
FDA Black Box Warning
The U.S. Food and Drug Administration (FDA) has issued a black box label warning for Xarelto, saying that the drug can lead to dangerous spinal bleeding also known as epidural or spinal hematomas. A hematoma is a pool of blood that occurs outside of blood vessels. Hematomas in the spine can lead to serious side effects such as permanent paralysis.
Those who are at greater risk are:
- Patients who use epidural catheters.
- Patients who have taken other drugs that affect the blood-clotting process. Platelet inhibitors or NSAIDs are some of them.
- Patients who have previous history of spinal trauma.
- Patients who have undergone spinal surgery in the past.
The agency’s warning also discourages undertaking any spinal procedures such as surgery while taking the drug.
Xarelto Internal Bleeding Lawsuits
Since Xarelto can cause uncontrollable internal bleeding, people who had the misfortune to be struck by this side effect often have to be hospitalized. Hospitalization can be expensive and cause further emotional trauma to the patient or the patient’s family, especially if the bleeding is fatal.
The first U.S. Xarelto lawsuits were filed in June 2014.
Virginia Stuntebeck is the plaintiff who filed a lawsuit against Xarelto’s manufacturer in Philadelphia Courts after having suffered severe injuries such as internal bleeding as a result of taking the drug. She had to be hospitalized in February 2013 because of acute gastrointestinal bleeding.
Stuntebeck alleges that the drug-maker did not sufficiently warn the public about the risks that Xarelto poses and should have never sold such a dangerous drug in the first place. The complaint says that Bayer and Johnson & Johnson either knew or should have known about the irreversible bleeding associated with the drug.
Pradaxa is another similar drug whose manufacturer, Boehringer Ingelheim, had to pay $650 million to settle numerous drug-injury cases.
If you or a close relative has suffered internal bleeding or other serious side effect as a result of taking Xarelto, you may be eligible for compensation. Our lawyers will answer any questions about your case. Call us at 877-725-6839 or use the form on the site to submit your case details. We offer a free and confidential case review to anyone who has suffered as a result of taking this dangerous drug.