Xarelto is a drug made by Bayer that is used for several reasons, but primarily to prevent the formation of blood clots in people who are vulnerable to them, and which can be fatal. Known as an anti-coagulant or a blood thinner, Xarelto is one among several newer types of clot-preventing drugs. These newer drugs are supposed to have been designed to be safer and more effective than the old stand-by blood thinner, warfarin, but there are already concerns.
Although Xarelto held great promise as a safer blood thinner and one that is easier to use and requires less monitoring than warfarin, it also has some serious problems. Dangerous and life-threatening bleeding, which cannot be reversed, has led to lawsuits against the manufacturer. There have even been accusations that Bayer marketed Xarelto while knowing about its defects. If you have experienced dangerous side effects of Xarelto, you too could start a lawsuit and seek monetary damages.
What is Xarelto?
Xarelto, generic name rivaroxaban, is a blood thinner used to prevent the formation of dangerous blood clots, which can lead to strokes and heart attacks. The drug was developed and is manufactured by Bayer, although the German pharmaceutical company partnered with Janssen Pharmaceuticals, part of Johnson & Johnson, to market the drug in the U.S.
Newer blood thinners like Xarelto were created to be better alternatives to warfarin or heparin, which have been used to prevent clots for decades. Drugs like warfarin have to be dosed specifically for each individual patient to be effective, but to also avoid excessive bleeding. Patients taking warfarin need to be monitored closely to make sure that bleeding doesn’t occur, or that if it does, it can be stopped before it becomes life-threatening. Xarelto has been marketed as a drug that can be taken more safely, with just one or two different doses and no need for close monitoring.
Uses for Xarelto
The U.S. Food and Drug Administration (FDA) first approved Xarelto in 2011 to be used in patients recovering from knee and hip surgery. These patients are vulnerable to clot formation and blood thinners are used to prevent them. Not long after, the FDA also approved it for use in patients with atrial fibrillation, a type of abnormal heart rhythm, to avoid clot formation.
By taking advantage of a fast track review process, which the FDA reserves for drugs that have a high potential benefit for patients, Bayer and Janssen soon got Xarelto approved for use as a treatment for blood clots, not just a preventative measure. It can be used to treat deep vein thrombosis and pulmonary embolism, the formation of clots in veins, typically in the legs, and in the lungs.
How it Works
All blood thinners work to prevent strokes and heart attacks by preventing the formation of blood clots. Blood clotting is a natural process, but when a clot forms where it shouldn’t, like in a vein or artery, it can travel to the heart, lungs, or brain and be fatal. Xarelto prevents clotting by targeting a particular chemical compound in the clotting pathway, factor Xa. By inhibiting this protein, the clotting pathway is shut down.
The biggest danger associated with taking any blood thinner is excessive bleeding. Because these drugs work by shutting down the clotting pathway, any bleeding can become dangerous. Normal clotting is the way that the body stops itself from losing too much blood, for instance when the skin is cut or scraped. When clotting is stopped, any type of bleeding can get out of control and become life threatening.
Different anticoagulant drugs act on the clotting pathway in different ways. Warfarin, because of how it acts on a substance called vitamin K, can be reversed with a vitamin K antidote. With careful monitoring, a patient on warfarin can be successfully treated for excessive bleeding. One major danger of Xarelto is that there is no antidote. Anyone with excessive bleeding while on the drug may not stop bleeding until all of it has left the body.
Signs of bleeding that patients on Xarelto should watch for include bloody or tarry stools, blood in the urine, bleeding gums, coughing up blood, heavy menstrual bleeding, nosebleeds, and any other type of bleeding that won’t stop. Any bleeding while on Xarelto should be reported immediately for emergency medical treatment.
FDA Black Box Warnings
Xarelto also comes with some black box warnings. These are emphasized warnings that the FDA requires for some drug packaging to alert patients to risks that are especially serious or life threatening. One black box warning states that premature discontinuation of use of Xarelto can lead to blood clot formation. The other warning is that there is a small risk that patients taking Xarelto and undergoing any kind of procedure involving a spinal puncture may become paralyzed.
Xarelto and Infections
Data from recent studies have shown another potential issue with the use of Xarelto. Surgeons giving Xarelto to patients undergoing knee and hip surgery found that those patients often came back with serious infections that had to be treated in the hospital. The wounds from surgery in these patients were infected and leaking. The risk of developing these complications was four times greater for the patients in the study who took Xarelto.
While there will always be risks of bleeding associated with blood thinners, the problem with Xarelto may be that the drug companies left out some critical data that revealed just how risky this drug is. In just 2015, Xarelto took in nearly $2 billion in sales, and many are accusing Janssen and Bayer of hiding data to boost those profits.
The clinical trial in question, called Rocket AF, took place from 2006 to 2010 and involved more than 14,000 patients. A peer reviewer—reviewing the results to be published in the New England Journal of Medicine—asked the drug company for some data and was not given all of them. It was also later found that the researchers in the trial were using a blood-reading device to take measurements that had been recalled. This calls into question all of the data from the trial.
Thousands of lawsuits have been filed against Bayer, Janssen, and Johnson & Johnson because of Xarelto. The companies are being accused of leaving out data, of failing to warn patients of the full risks of using the medication, and of marketing a drug known to have serious risks as safer than it really is. There is also some question as to whether or not these companies can truthfully claim that Xarelto is more effective than warfarin.
Lawsuits against the maker of a similar, but slightly older blood thinner, Pradaxa, have already led to payouts in the hundreds of millions for people who suffered from excessive bleeding and their loved ones. If you have used Xarelto and experienced excessive bleeding, or a family member died from bleeding caused by Xarelto, you could have a strong case against the manufacturers. Lawsuits are also expected to be filed for those who have experienced infections after surgery. You can get in on these lawsuits or file your own to try to seek the compensation that these drug companies owe to people like you.