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Doctors prescribe Bayer’s billion-dollar blood thinner Xarelto to prevent blood clots and protect people from strokes. But the drug may also cause irreversible internal bleeding that can lead to hospitalization and death. Lawsuits filed against Bayer claim the company did not warn the public and want the drug removed from the market.
Xarelto (rivaroxaban) is one of the newest anticoagulants — more commonly known as blood thinners. The drug is an oral medication developed by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals and belongs to a class of medications known as Factor Xa inhibitors. Blood thinners prevent dangerous blood clots that can obstruct the blood flow to the vital organs. Unlike older anticoagulants that require doctors to prescribe specific doses for each individual, Xarelto belongs to a new type of oral anticoagulant that is prescribed in one uniform dose.
The Food and Drug Administration (FDA) approved Xarelto for use in patients who have had knee or total hip replacement surgery to reduce the risk of blood clots and reducing the risk of stroke in people with AF. Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
One of the most severe side effects of Xarelto is uncontrolled bleeding. When bleeding occurs near a major organ, such as the brain, lungs or kidneys, blood flow to that organ is interrupted, causing it to lose some or all of its functionality. Also, pools of blood may form within the body and can cause other severe health risks. Parenchymal or intraparenchymal hemorrhages, or brain bleeds, are the most deadly. The drug has no known antidote for these bleeds.
Researchers are also finding that the drug may increase the risk of wound complications such as infection and leakage in knee and hip replacement patients. These complications can be severe and require additional surgery to treat.
The most common side effects of Xarelto are bleeding complications, including major bleeding events. Some patients taking the drug suffered minor to fatal bleeding as well as severe complications from blood loss. Not all patients will suffer the same side effects. Some may tolerate the drug better than others and larger doses may cause more problems. Seniors are at increased risk Xarelto side effects.
Other side effects of Xarelto include:
In addition to severe bleeding, Xarelto is also linked to serious wound infections and leakage. Orthopedic surgeons across the country observed that among their patients who take Xarelto after hip- or knee-replacement surgery may end up back in the operating room to remove implants and undergo intense antibiotic therapy for weeks and even months. Surgeons who noticed the effects started assessing the risk.
One of the first published studies linking the blood thinner to these new complications appeared in the Journal of Bone and Joint Surgery in 2012. Researchers followed more than 13,000 people after hip or knee surgery – people who took either Xarelto or Heparin. Those in the Xarelto group had nearly four times the risk of wound complications.
A British study presented at the annual meeting of the American Academy of Orthopaedic Surgeons in 2012 showed that people who took Xarleto had a significant return-to-surgery rate within 30 days. Doctors in the study stopped prescribing the drug when "large, fresh wounds" were involved. Instead, they switched patients to tinzaparin, an older anticoagulant.
One 2015 study by Dr. Olubusola Brimmo and colleagues revealed patients who took Xarelto after hip or knee replacement surgery had a relative infection risk of 10.7 compared to patients who used other drugs.
The FDA added a black box warning for increased risk of blood clots if Xarelto is stopped prematurely. Patients who have spinal surgery or epidurals are at increased risk of blood clots in the spine that may cause paralysis.
The FDA added a section to the Warnings and Precautions portion of the medication insert. It warned Xarelto has no antidote, and advises patients to watch for signs of excessive bleeding. Xarelto is not for use in patients with prosthetic heart valves.
The FDA added thrombocytopenia (platelet deficiency) and hepatitis under the list of postmarketing adverse reactions.
Taking Xarelto with selective serotonin reuptake inhibitor (SSRI) and serotonin norepinephrine reuptake inhibitor (SNRI) antidepressants may increase the risk of bleeding.
There are a number of other blood thinners currently on the market. Some are in the same class as Xarelto and others work differently and have different side effects. All blood thinners carry the risk of bleeding, however.
Another better-known oral anticoagulant is the drug Pradaxa (dabigatran etexilate), manufactured by Bayer’s competitor, Boehringer-Ingelheim. Xarelto and Pradaxa are similar, but they work in different ways. Xarelto inhibits a protein involved in the coagulation process called Factor Xa, which interrupts the blood-clotting process and prevents another protein, thrombin, from forming. Pradaxa directly inhibits thrombin from forming. The drug's maker already spent hundreds of millions to settle bleeding lawsuits linked to the medication.
For decades, warfarin — also known by the brand names Coumadin and Jantoven — was the standard of care for preventing blood clots. Unlike with Xarelto, patients must make frequent visits to the doctor for blood tests and dosage adjustments. There are also dietary restrictions for people who take this drug.
In 2011, the New England Journal of Medicine published the results of the ROCKET AF study that compared Xarelto to warfarin in patients with AF. The FDA said the study failed to show that Xarelto was more effective than warfarin. Xarelto is also known to cause more abdominal bleeding than warfarin. But warfarin caused more brain bleeding.
Like Xarelto, Eliquis (apixaban) is a Factor Xa inhibitor and works the same way to stop clots from forming. The FDA approved it a year after Xarelto, and it also lacks an antidote for major bleeding. But, in the clinical trial, ARISOTLE, it showed a 30 percent reduction in major bleeding over warfarin and a 50 percent reduction in hemorrhagic stroke — both of these numbers are superior to Xarelto.
Xarelto is a blood thinner and certain medications may increase the risk of bleeding, while others may interfere with the way Xarelto works. Some types of drugs that may react with Xarelto include: anti-seizure drugs, antibiotics, anti-fungal medications and drugs used to treat HIV.
Xarelto comes in doses of 10, 15, and 20 mg, and is prescribed in different amounts based on treatment indication. Lower doses are often prescribed following orthopedic surgeries. Patients should take the 15 and 20 mg doses with their evening meal unless otherwise indicated. Unlike warfarin, Xarelto does not have any dietary restrictions.
Some common dosage recommendations based on indication include:
If patients miss a dose, they should take the missed dose as soon as possible on the same day. The next dose should be taken at the regularly scheduled time. Doctors advise patients to discontinue Xarelto use for 24 hours before and after surgical procedures.
In case of an overdose, patients should seek emergency medical care immediately.
Depending on the diagnosis, a doctor may recommend long-term use of the drug. For example, for preventing blood clots after surgery, a patient may take the drug for a few days before stopping. If a patient has atrial fibrillation and needs to prevent blood clots, their doctor may recommend a life time regimen of Xarelto.
|Adverse Drug Reactions|
|System/Organ Class||XARELTO 10 mg N-4487 n(%)|
|Injury, poisoning and procedural complications|
|Wound secretion||125 (2.8)|
|Musculoskeletal and connective tissue disorders|
|Pain in extremity||74 (1.7)|
|Muscle spasm||52 (1.2)|
|Nervous system disorders|
|Syncope (loss of consciousness)||55 (1.2)|
|Skin and subcutaneous tissue disorders|
|Pruritus (severe itching)||96 (2.1)|
In a Phase III study intended to examine the drug’s safety, 73 percent of the 16,041 participants who took at least one dose of Xarelto experienced side effects. Some of the most prominent serious side effects of Xarelto were anemia and bleeding events. People who took a higher dose were more likely to suffer from bleeding.
In addition to these side effects and drug interactions, the FDA released a warning that patients who suddenly stop taking Xarelto can be at increased risk for developing blood clots.
|Participants of the study also suffered from these side effects:|
|Dizziness||Hemorrhaging in the eye||Headache|
|Rapid heartbeat||Low blood pressure||Bruising|
|Rectal bleeding||Gastrointestinal and Urogenital bleeding||Nose bleeds|
Knowledge is key when attempting to prevent blood clots. Each treatment carries benefits and risks. Drugwatch provides comprehensive overviews of anticoagulants like Pradaxa, Eliquis and warfarin. The National Heart, Lung, and Blood Institute and the Agency for Healthcare Research and Quality also provide a wealth of information available online.
People taking Xarelto or other blood thinners should also follow some basic safety tips to lower their risk for bleeding events.
Support is also one of the most important resources for people taking Xarelto or other blood thinners. Friends, family and other caregivers often help patients attend doctor visits, blood monitoring appointments and other important activities. Caregivers can become fatigued though. Fortunately, there are many resources available online and support groups for caregivers can be found in many communities.
People who took Xarelto and suffered from irreversible bleeding filed lawsuits for compensation for medical bills, injuries and emotional trauma. Families of people whose bleeds were fatal also sought justice for their loved ones. There are more than 4,500 Xarelto lawsuits pending in federal court before Judge Eldon F. Fallon. The drug's predecessor, Pradaxa, already led to a number of lawsuits filed against its manufacturer because of complications such as excessive bleeding and death. Its maker paid $650 million dollars to settle about 4,000 claims.
Some of the lawsuits filed against Bayer and Johnson & Johnson say that the company failed to warn the public of the dangers of irreversible bleeding. Many of those injured were rushed to the hospital with severe bleeding. Lawsuits claim the drug's makers misrepresented the safety and effectiveness of the drug. Those currently involved in litigation allege the companies continued to sell Xarelto even when they knew it was dangerous.