Xarelto (Rivaroxaban), is a prescription drug, manufactured by Bayer and Janssen Pharmaceuticals, used to reduce the risk of stroke and blood clots in those with atrial fibrillation. Xarelto is also used to treat deep vein thrombosis and pulmonary embolism, as well as to prevent those conditions from recurring. In patients who have had knee or hip replacement surgery, Xarelto may be used to reduce the risk of blood clots forming in the legs or lungs. Unlike Warfarin, Xarelto is prescribed in a uniform dosage which is not dependent on age, weight or gender. There are no known food interactions among patients taking Xarelto, although there are certain adverse reactions with other drugs or supplements. Xarelto reduces the ability of the blood to clot, thereby preventing blood clots from forming in blood vessels. In some patients Xarelto may be used in the treatment of atrial fibrillation.
While the official Xarelto website indicates that more than seven million people worldwide have been prescribed Xarelto, reading further will also give you some idea of the potential risks associated with the drug. Xarelto’s label includes two “black box” warnings—the FDA’s most serious kind of warning. The first tells patients who are undergoing spinal procedures such as a spinal tap or receiving spinal anesthesia while taking Xarelto that they could develop a spinal hematoma and potentially end up paralyzed. The second warning informs those with non-valvularatrial fibrillation that discontinuing Xarelto could increase the risk of blood clots and strokes. In short, the risk of Xarelto internal hemorrhage, Xarelto stroke, and Xarelto blood clots may be high enough to discourage many from taking the drug. German media reported last fall that during the first eight months of 2013, Bayer reported 968 side-effects tied to Xarelto, including 72 deaths. These numbers were up from the 2012 reports of 750 adverse reactions and 58 deaths tied to Xarelto.1
What are the Xarelto Risks vs. Benefits?
According to a 2012 Medscape.com article, a ROCKET-AF analysis of Xarelto vs. Warfarin showed that patients with atrial fibrillation were more likely to experience Xarelto gastrointestinal hemorrhage when treated with Xarelto than with Warfarin. During the annual meeting of the American College of Chest Physicians, Dr. Christopher Nessel noted that “A careful benefit/risk assessment is needed prior to prescribing Rivaroxaban for high-risk patients.” The patients who experienced major GI bleeds were more likely to be a previous or current smoker, to have mild anemia or to have experienced GI bleeding in the past.
Risks of Xarelto Gastrointestinal Hemorrhage
There is currently one case study regarding Xarelto gastrointestinal hemorrhage; a 58-year old Caucasian man presented with acute onset severe rectal bleeding. The man had undergone total hip arthroplasty four weeks prior and had been prescribed Xarelto post-op. The bleeding was so severe that nine units of red blood cells were required; after being transferred to another hospital, another eight units of red blood cells were given over a 48-hour period to manage the patient’s ongoing Xarelto gastrointestinal hemorrhage. Xarelto was immediately discontinued, and the patient’s condition improved, with the Xarelto gastrointestinal hemorrhage ceasing after another 48 hours had passed.
A Kentucky woman filed a product liability lawsuit against Janssen and Bayer, alleging she suffered severe Xarelto gastrointestinal hemorrhage and nearly bled to death. Virginia Stuntebeck stated she began using Xarelto in July, 2012, to treat her atrial fibrillation. In February, 2013, Stuntebeck was hospitalized with Xarelto gastrointestinal hemorrhage, which her doctors had difficulty stopping. Unlike Warfarin, Xarelto does not have an FDA-approved reversal agent which allows doctors to quickly stop the drug’s blood thinning effects.
The Risks of Xarelto Internal Bleeding
While Xarelto may have several serious side effects, perhaps the most dangerous is Xarelto internal bleeding. Of course the risk of excessive bleeding exists with all blood thinners; Xarelto is more dangerous because it has no known antidote. Warfarin, one of the oldest blood thinners, can also cause bleeding, however ER physicians can use a vitamin K antidote to slow the bleeding. Xarelto internal bleeding can occur due to the way the blood thinner works. Xarelto blocks specific proteins in the blood which normally start the clotting process. It can take as long as 24 hours for Xarelto to be flushed out of the body. In the elderly, this process can take even longer; the anticoagulation effect tends to last longer in older adults as their bodies have a more difficult time flushing the drug out of their system. This puts seniors who fall or hit their heads at a much higher risk of Xarelto internal bleeding, particularly the possibility of a Xarelto intracranial hemorrhage.
Xarelto has a black box warning regarding the risk of Xarelto paralysis due to epidural or spinal hematomas. Patients receiving neuraxial anesthesia or undergoing a spinal puncture can develop an epidural or spinal hematoma, causing long-term or even permanent paralysis. Patients who are scheduled for a spinal procedure should make sure their physicians are all aware they are taking Xarelto. The risk for Xarelto paralysis increases in those who have an indwelling catheter, have a history of traumatic or repeated spinal punctures or epidurals, have a history of spinal surgery or are taking the following drugs along with Xarelto: NSAIDs, platelet inhibitors or other anticoagulants. The timing between stopping Xarelto and undergoing spinal procedures in order to avoid Xarelto paralysis is not known, therefore the benefits and risks should be carefully assessed.
Have there been Xarelto Deaths?
As noted above, during the first eight months in 2013, there were 72 Xarelto related deaths, up from 58 deaths associated with Xarelto in 2012. Overall, the number of side-effect reports for Xarelto appears to be increasing, making doctors wary of using Xarelto as a first-line treatment. Despite evidence which appears to the contrary, a Bayer spokesman told Reuters that Xarelto’s benefits still outweigh its risks. Xarelto’s predecessor and direct competitor, Pradaxa, has garnered even more adverse event numbers, but it is also used in more patients.
While there is no known antidote to Xarelto hemorrhage, Bayer and Johnson & Johnson are working with Portola Pharmaceuticals to test one potential antidote, and Pradaxa’s manufacturer is doing the same. At the same time, Bayer and Johnson & Johnson are studying Xarelto to determine whether the drug could be effective in the treatment of heart failure and coronary artery disease. If you or a loved one has suffered Xarelto blood clots, Xarelto stroke or Xarelto hemorrhage, you are encouraged to speak to a knowledgeable Xarelto attorney who can assess your situation and protect your rights.