Xarelto (rivaroxaban) is an anticoagulant (blood thinner) manufactured by Bayer and marketed in the United States by Janssen (part of Johnson & Johnson).
The blood thinner is prescribed more than 6.7 million times each year and has earned Bayer more than $1 billion, but it’s also linked to side effects that have prompted thousands of personal injury lawsuits.
Newer anticoagulants like Xarelto are marketed as a superior alternative to the older blood thinner warfarin, which has been on the market for decades and is proven to be reasonably safe and effective.
Xarelto is touted as having benefits over warfarin, such as once-daily dosing and no need for medical monitoring. Unlike warfarin, however, Xarelto does not have an antidote to reverse uncontrollable bleeding.
The clinical data used to approve Xarelto has been called into question, as has Bayer’s transparency about drug side effects.
These and other criticisms are raised in Xarelto lawsuits that seek compensation for patients allegedly injured or killed by the blood-thinning medication.
About Xarelto and Blood Clots
Anticoagulants are designed to prevent blood clots, which can block blood flow to vital organs and cause death.
Blood clotting is a normal bodily process that aids in healing, but blood clots can also form abnormally within blood vessels, break away, travel through the bloodstream, become lodged in a blood vessel and block the flow of blood to the lung and heart, or brain—an event known as a thromboembolism.
Some patients, including those recovering from certain injuries and those with certain health conditions, are at increased risk of blood clot formation and may be prescribed a medication such as Xarelto to reduce the risk of thromboembolism.
Blood-thinning medications don’t actually thin the blood, nor do they dissolve existing clots. Rather, they prevent clots from forming in the first place. They can also keep clots from getting larger.
Blood thinners affect specific chemical reactions in the body that lead to blood clotting. Rivaroxaban, the active ingredient in Xarelto, prevents clots from forming by blocking one type of clotting factor called factor Xa.
Approved Uses for Xarelto
Xarelto is FDA-approved for the following uses:
- Prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgeries (July 2011)
- Reduction of the risk of stroke in patients with a type of abnormal heart rhythm called non-valvular atrial fibrillation (November 2011)
- Treatment of DVT/PE and reduction of recurrent DVT/PE (November 2012)
Xarelto vs. Warfarin
For decades, warfarin was the industry-standard blood thinner. First approved in 1954, warfarin is widely available as a generic drug, and it’s cheap: an annual supply of the drug costs about $200.
Compare this with an estimated annual cost of $3,000 for Xarelto, and you begin to see why manufacturers wanted to make warfarin alternatives that are still under patent protection and can be sold for much higher prices.
The problem is that, in order to be approved by the FDA, new blood thinners have to offer benefits beyond warfarin. While not without bleeding risks of its own, warfarin is proven to prevent serious blood-clot-related events.
All blood thinners are risky because too much anticoagulation can lead to hemorrhage, while too little can fail to prevent clot-related disorders like heart attacks, stroke, and pulmonary embolism.
Manufacturers seeking entry into the blood thinner market focused on making a drug that was not necessarily superior to warfarin, but was at least as effective as warfarin, while also offering other advantages.
The main advantages touted for Xarelto are that it requires no regular blood monitoring, no dietary restrictions, and no frequent dose adjustment—all things that warfarin does require.
But unlike warfarin, which has a simple antidote (Vitamin K) to reverse serious bleeding, Xarelto has no antidote to stop uncontrolled bleeding.
This is something that Bayer fails to emphasize in direct-to-consumer advertising that says Xarelto is as effective as warfarin. Bayer also failed to warn about the lack of a Xarelto bleeding antidote in product labeling when the drug was first marketed in the U.S.
The FDA warned Janssen about the company’s improper marketing of Xarelto in June 2013, saying that an advertisement for the drug “is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.” The advertisement in question presented the benefits of Xarelto in bold, colorful text and graphics, but presented risk information without similar emphasis. The ad also said that “there are no dosage adjustments” needed for Xarelto, even though the prescribing information recommends lowering the dosage for certain patients.
Controversy Surrounding Xarelto Approval
The clinical evidence used to support FDA approval of Xarelto has questionable aspects.
The approval of Xarelto for prevention of DVT and PE in patients undergoing hip replacement or knee replacement surgeries was based on clinical trials known as the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism studies (“RECORD” studies). RECORD showed that Xarelto was superior to the comparison drug (enoxaparin) for preventing blood clots after knee and hip surgery, but it also showed a greater incidence of Xarelto triggering bleeding that leads to decreased hemoglobin levels and requires transfusions.
Moreover, the approval of Xarelto for reducing the risk of stroke and embolism in patients with non-valvular atrial fibrillation was based on a clinical trial known as the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation study (“ROCKET AF”). ROCKET AF showed that Xarelto was not inferior to warfarin for the prevention of stroke or embolism, with a similar risk of major bleeding. But in the Xarelto group, gastrointestinal bleeding occurred more frequently, as did bleeding that led to a drop in the hemoglobin level, or bleeding that required transfusion.
During the FDA’s review of the ROCKET AF study, some reviewers did not want Xarelto approved for the new use because:
- In the 30 days after the study ended, Xarelto users had 22 strokes, compared to six strokes for warfarin users.
- Xarelto was administered once daily during the trial, even though there is evidence that the drug should be given twice per day.
- Warfarin administration in the study was poorly managed, putting patients in the control group at increased risk and making Xarelto look disproportionately safe.
- The trial did not make clear that Xarelto is as safe and effective as warfarin when warfarin therapy is well-controlled.
- Pradaxa (another popular anticoagulant) was found to be superior to warfarin in a similar analysis, while Xarelto was not found in ROCKET AF to be superior to warfarin.
Doctors opposed to Xarelto approval in 2011 questioned the design and conduct of the ROCKET trial and argued that patients could be “at greater risk of harm from stroke and/or bleeding” if they took Xarelto than if they were skillfully treated with warfarin.
Xarelto prescribing information admits that, “There is insufficient experience to determine how XARELTO and warfarin compare when warfarin therapy is well-controlled.”
More recently, it was revealed that faulty equipment was used in the warfarin arm of ROCKET AF, further calling into question the study’s results.
The scandal deepened when the Duke researchers hired by Janssen/Bayer to run ROCKET AF published an analysis in the New England Journal of Medicine (NEJM) saying that the faulty device had no bearing on study results, but omitted key data that would have made this clear. Janssen/Bayer are accused of being complicit in the omission because they knew about the missing data but remained silent.
Xarelto Adverse Event Reports
The FDA maintains a database to track patient reports about problems with drugs and medical devices. Xarelto has been the subject of numerous adverse event reports in recent years.
- During its first full year on the market (2012), 2,081 severe adverse events involving Xarelto were reported to the FDA, including 151 deaths.
- In the first quarter of 2013, the number of serious adverse events associated with Xarelto surpassed those of Pradaxa (another new anticoagulant), which ranked as the number one reported drug in terms of adverse events in 2012.
- During 2014, FDA received 3,331 serious adverse event reports about Xarelto, including 379 deaths, 1,129 embolic-thrombotic events (treatment failure), and 1,657 hemorrhage events.
The Institute for Safe Medication Practices (ISMP), a nonprofit organization that tracks FDA adverse event reporting, said that Xarelto data sends a “strong signal” regarding its safety and that there is “evidence of sufficient weight to justify an alert to the public and the scientific community, and to warrant further investigation.”
Thousands of lawsuits have been filed against Bayer/Janssen over Xarelto’s side effects. The lawsuits allege that Xarelto caused users to experience irreversible bleeding that in some cases proved fatal. They accuse the manufacturers of misrepresenting the safety and effectiveness of Xarelto and not providing adequate warnings about its risks.
Nearly 5,000 cases have been consolidated in Louisiana federal court, with the first cases expected to be tried in early 2017.
More than 700 Xarelto lawsuits are also consolidated in Philadelphia state courts.
Did you or a loved one suffer bleeding complications while taking Xarelto? Learn how a lawsuit can help. It’s not too late to file a Xarelto lawsuit, but it’s important to act quickly and preserve your rights.