Xarelto is the number one prescribed blood thinner in its class with more than 13 million prescriptions filled in the U.S., according to the manufacturers. Xarelto has been gaining recognition, thanks to a number of celebrity endorsements and dozens of lawsuits that allege the drug caused life-threatening bleeding episodes in some patients. What is Xarelto and why has it come under such scrutiny? Read on for more information about the blockbuster drug that’s making headlines.
What is Xarelto and what is it used for?
Xarelto is an anticoagulation medication (blood thinner) used to treat and prevent blood clots in certain patients. The main ingredient in Xarelto is rivaroxaban.
Xarelto is indicated to treat and prevent deep vein thrombosis (DVT), a blood clot that forms in a deep vein, usually in the legs. It can also treat and prevent pulmonary embolism (PE), a blood clot in the lungs. DVT and PE are risk factors of surgeries and medical conditions that affect how the blood clots.
Xarelto is also used to treat people with a certain heart condition called atrial fibrillation, or AFib. AFib is characterized by an irregular heartbeat where the two upper chambers of the heart, called the atria, beat too quickly and don’t pump all of the blood into the two lower chambers, called the ventricles, like they should. As a result, blood clots can form in the atria. If a clot breaks off, it could travel to the brain causing a stroke.
How does Xarelto work?
Xarelto belongs to a new class of drugs called factor Xa inhibitors. These drugs work directly on factor Xa, an enzyme that plays a role in the body’s coagulation process.
The main ingredient in Xarelto, rivaroxaban, works quickly inside the body, interrupting the coagulation process by inhibiting the formation of factor Xa, which inhibits the formation of other key enzymes responsible for coagulation, including thrombin. Without these key enzymes, the blood does not clot.
Who makes Xarelto?
Xarelto is manufactured by pharmaceutical giant Bayer Healthcare AG and marketed by Johnson & Johnson subsidiary Janssen Pharmaceuticals in the United States.
When was Xarelto approved by the FDA?
Xarelto was introduced to the market in July 2011 after gaining approval from the Food and Drug Administration (FDA).
The drug was initially approved to treat DVT and PE in patients undergoing hip replacement surgery or knee replacement surgery. Its use was expanded about a year and a half later to include prevention of DVT and PE and to reduce the risk of stroke and embolism in patients with AFib.
What are the possible side effects of Xarelto?
The most common side effect of Xarelto is the risk of bleeding. Xarelto increases the risk of bleeding and can cause serious or fatal bleeding, the drug’s label states. People taking Xarelto should watch for the following signs and symptoms of bleeding:
- Unexpected bleeding or bleeding that lasts a long time, such as
- Nose bleeds that happen often
- Unusual bleeding from the gums
- Menstrual bleeding that is heavier than normal or vaginal bleeding
- Bleeding that is severe or you cannot control
- Red, pink or brown urine
- Bright red or black stools
- Cough up blood or blood clots
- Vomit blood or your vomit looks like coffee grounds
- Headaches, feeling weak or dizzy
- Pain, swelling or new drainage at wound sites
Other side effects are also possible while taking Xarelto, including:
- Back pain
- Joint or muscle pain
- Bowel or bladder dysfunction
- Burning, crawling, itching, numbness, prickling, “pins and needles” or tingling feelings
- Difficulty with breathing or swallowing
- Leg weakness
- Abdominal or stomach pain or swelling
- Fast or irregular heartbeat
- Fever with or without chills
- Loss of appetite
- Nausea or vomiting
- Red skin lesions
- Red, irritated eyes
- Sore throat
- Sores, ulcers or white spots in the mouth or on the lips
- Tightness in chest
- Unpleasant breath odor
- Unusual tiredness or weakness
- Yellow eyes or skin
- Puffiness or swelling of the eyelids, or around the eyes, face lips or tongue
- Hives, itching or skin rash
- General feeling of tiredness or weakness
- Unusual bleeding or bruising
- Cough or hoarseness
- Blistering, peeling or loosening of the skin
- Blurred vision
- Clay-colored stools
Some users of Xarelto have also listed hair loss and weight gain as a possible side effect of the drug.
How do I take Xarelto?
Xarelto is available in 10 mg, 15 mg and 20 mg tablets. A patient’s dose will vary depending on certain factors, including what Xarelto is being used to treat.
The makers of Xarelto suggest taking the 15 mg and 20 mg doses with food, specifically your evening meal if you’re treating AFib. The 10 mg tablet can be taken with or without food.
It is possible to overdose on Xarelto. Symptoms of overdose may include:
- Unusual bleeding or bruising
- Bloody, black or tarry stools
- Blood in urine
- Coughing up blood or vomiting blood or materials that look like coffee grounds
Do I need to see my doctor for routine blood tests while taking Xarelto?
Unlike warfarin, patients taking Xarelto do not need to go in for routine blood monitoring because the drug “has been shown to deliver a predictable blood thinning effect,” according to the drugmakers.
Blood monitoring is necessary for patients taking warfarin because the dosage requirement changes based on age, race, weight, gender and dietary changes. Xarelto delivers the same blood-thinning effect for all patients regardless of their age, race, weight, etc.
Do I need to change my diet while taking Xarelto?
Unlike warfarin, Xarelto has no known dietary restrictions. According to the drugmakers, patients should “continue to eat the healthy foods” they like.
Because vitamin K can interfere with warfarin, patients taking the drug need to restrict their diet and eat less vitamin-K-rich foods, like green leafy vegetables. Patients taking Xarelto do not need to restrict their diet because foods do not decrease the effectiveness of Xarelto.
Some research does suggest that grapefruits and grapefruit juice can increase the amount of Xarelto in a patient’s blood. Xarelto is processed by enzymes in the intestines. Grapefruit and grapefruit juice contain compounds that slow down this process which can lead to a buildup of Xarelto in the blood. This can cause more side effects and increase a person’s risk for bleeding.
Do I need to stop taking Xarelto before surgery?
Your doctor may ask you to stop taking Xarelto before any planned surgeries, medical or dental procedures to decrease your risk for bleeding. Your doctor will tell you when to stop taking Xarelto and when to start again after your surgery or procedure.
What are some complications associated with Xarelto?
Xarelto may cause serious, life-threatening complications in some patients, including:
- Gastrointestinal (GI) and other internal bleeding
- Brain hemorrhaging
- Death from bleeding out
- Heat attack
- Pulmonary embolism
- Organ failure
What drug interactions can occur while taking Xarelto?
Certain drugs may increase the risk for side effects if taken with Xarelto. The makers of Xarelto warn the following drugs should not be taken while using Xarelto without first talking with your doctor:
- Certain antibiotic, antiviral and antifungal medications (Ketoconazole, ritonavir, clarithromycin, erythromycin, fluconazole, rifampicin)
- The anticonvulsant medication phenytoin
- Other anticoagulants like Warfarin and Lovenox
- Aspirin and other NSAIDs like Ibuprofen, Advil, Motrin, Aleve and Celebrex
The following drugs should not be taken together with Xarelto in patients with impaired kidney function:
- The antiarrhythmic medication dronedarone (Multaq)
- The antihypertensive and calcium channel blockers verapamil (Covera-HS, Calan, Verelan) and diltiazem (Dilt-cd, Cardizem, Tiazec)
- The antibiotic and gut motility stimulator erythromycin (Ilotycin, Ery-Ped, Ery-tab)
How safe is Xarelto?
Studies indicated an increased risk for gastrointestinal and other bleeding in patients taking Xarelto, and other new-generation blood thinners. A 2012 study published in the BMJ concluded the new anticoagulants, including Xarelto, were “generally associated with a higher bleeding tendency.”
While the risk of bleeding is increased with all anticoagulants, what makes this risk especially dangerous for patients taking Xarelto is the lack of an approved antidote. If the bleeding does start, how do you make it stop?
Even the study that led to the approval of Xarelto by the FDA in 2011 has been called into question. The Rocket AF trial, as it was called, came under scrutiny after the drug’s manufacturers were accused of withholding important data from a peer-reviewed medical journal.
Johnson & Johnson and Bayer were accused of staying silent as researchers at Duke University allegedly left out test results from about 5,000 blood samples taken from patients on warfarin during the trial. Patients taking warfarin were compared to patients taking Xarelto to see how the drugs stood up to one another in preventing life-threatening blood clots.
The blood samples were analyzed by doctors participating in the trial using a special medical device called an INRatio Monitor System; the blood samples were also sent to a central laboratory for analysis.
The results from the INRatio Monitor System came under scrutiny after the FDA recalled the device in 2014 for potentially giving false readings in patients with certain medical conditions. Some critics say the faulty device called the whole Rocket AF trial into question. They worry bad testing could have skewed the results in Xarelto’s favor.
More than a year after news of the recalled medical devices broke, researchers from the trial published an analysis in the same journal in which the original trial was published, the New England Journal of Medicine. The analysis argued the medical devices did not impact the study’s results. The researchers, however, did not mention that the same blood samples were analyzed at an independent laboratory.
If blood samples tested by a potentially faulty device were also tested independently at a laboratory, why not publish those lab results to verify the results from the faulty device?
The trial researchers maintain the results from Rocket AF remain consistent, despite the recall of the medical device and despite the omission of the tested blood samples. The editor in chief of the New England Journal of Medicine also maintains the journal had not been misled about the data.
But if the researchers, paid by Johnson & Johnson and Bayer to test the safety and efficacy of a new drug, felt it was OK to leave out data – data that could have lowered the red flags raised after the INRatio device was recalled – what else could the researchers and drug companies be hiding?
How does Xarelto cause uncontrollable bleeding?
Blood clots are necessary to stop the body from losing too much blood. When you cut your finger, your body triggers an intricate process to stop your cut from bleeding.
Anticoagulants, or blood thinners, prevent the formation of dangerous blood clots in the body by hindering the coagulation process. This means they can also prevent helpful blood clots from forming.
All anticoagulation medications have the potential to cause uncontrollable bleeding in patients. A major difference between traditional blood thinners like warfarin and novel blood thinners like Xarelto is the existence of a reversal agent.
Vitamin K can be used to stop uncontrollable bleeding in patients taking warfarin. There is no antidote available to stop bleeding in patients taking Xarelto. This is what can make Xarelto so dangerous.
Has the FDA issued any warnings about Xarelto?
Since its initial approval by the FDA in 2011, the Xarelto label has carried a “black box” warning about the risk of paralysis in patients receiving an epidural or undergoing spinal puncture. A “black box” warning is the FDA’s strongest warning about a drug or medical device.
Xarelto’s black box warning was updated to include a warning about the risk of blood clots in patients with AFib who stop taking Xarelto. The label warns patients should talk to their doctor before stopping the medication.
What other blood thinners are available?
There are several different anticoagulants on the market today, some of which belong to the same class of drugs as Xarelto.
One of the first anticoagulation medications approved by the FDA, warfarin was marketed under the brand name Coumadin. Warfarin is an oral medication belonging to the class of drugs called Vitamin K antagonists. These drugs help stop blood clots from forming by depleting active vitamin K, an important factor in coagulation. If an uncontrollable bleeding event occurs, patients are administered a Vitamin K antidote to stop the bleeding.
While warfarin is highly effective, it has shortcomings compared to other blood thinners. Patients taking warfarin must undergo routine blood monitoring to check the effectiveness of the drug and dosage requirements. Patients must also eat a restricted diet as foods high in vitamin K can interact with the drug.
Heparin is administered intravenously. It is fast-acting and often used in hospitals. It is also safe for pregnant women, unlike warfarin which can cause fetal bleeding and other birth defects. Heparin has been used as an anticoagulant for decades and works by binding to a certain enzyme inhibitor in the body to stop blood from clotting. The antidote to heparin is protamine sulfate.
There are several derivatives of heparin called low-molecular-weight heparin. These drugs include:
- Dalteparin sodium (Fragmin)
- Danaparoid sodium (Orgaran)
- Enoxaparin (Lovenox)
- Tinzaparin (Innohep)
- Fondaparinux (Arixtra)
Novel Oral Anticoagulants (NOACs)
Novel Oral Anticoagulants, or NOACs, are a new class of blood thinners first approved merely six years ago in 2010. There are currently four factor NOACs on the market today, including:
- Apixaban (Eliquis)
- Edoxaban (Savaysa)
- Rivaroxaban (Xarelto)
- Dabigatran (Pradaxa)
Factor Xa Inhibitors are a type of NOAC and include the drugs Xarelto, Eliquis and Savaysa. Pradaxa is a direct thrombin inhibitor, a second type of NOAC.
Currently, there are no studies showing how well these drugs work in comparison to each other. There is also only one antidote approved to stop uncontrollable bleeding and only for the drug Pradaxa. The antidote, Praxbind, was approved by the FDA late last year in 2015.
How much does Xarelto cost?
Xarelto is only available as a brand name drug. At this time, no generic equivalent is available. Without insurance, the price of a three-month supply of the 20 mg pills could be up to $1,200. Johnson & Johnson does offer a patient assistance program to help those without insurance afford the cost of their prescriptions. Not everyone will be eligible for this program.
Celebrities are endorsing Xarelto. Does that mean the drug is safe?
Xarelto has been backed by several different celebrities and sports stars, including NBA all-star Chris Bosh, champion Nascar driver Brian Vickers, hall-of-fame golfer Arnold Palmer and comedian and actor Kevin Nealon. They have all been featured in ad campaigns, including television commercials, and they are front and center on the Xarelto website.
Celebrity endorsements do not increase or decrease a drug’s effectiveness or safety. Celebrity endorsements are a marketing tactic used by pharmaceutical companies to increase sales of their drugs.
Has Xarelto been recalled?
In 2014, the makers of Xarelto recalled about 13,500 bottles of Xarelto due to possible microbial contamination. The drug has not been recalled otherwise.
Are there lawsuits against the makers of Xarelto?
Yes. There are currently over 4,500 lawsuits pending in U.S. district court against the makers of Xarelto, Janssen Pharmaceuticals and Bayer AG. These lawsuits were consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Louisiana with U.S. District Judge Eldon E. Fallon presiding.
There are also dozens of cases consolidated in a mass tort program pending in the Complex Litigation Center in Philadelphia.
These lawsuits claim the drugmakers failed to warn consumers about the potential risks associated with their drug. So far, no settlements have been reached.
I was harmed after taking Xarelto. Do I qualify for a claim?
If you took Xarelto and experienced a serious bleeding event for which you were hospitalized, you may be entitled to compensation. The experienced lawyers and attorneys at National Injury Help want to hold the pharmaceutical companies responsible for the pain and suffering they have caused so many people. Contact us today for a free case evaluation to see if you qualify for the Xarelto lawsuit. Call 1-800-214-1010 or use the form on the right-hand side of your screen.