(888) 645-1617

Xarelto

Doctors prescribe Bayer’s billion-dollar blood thinner Xarelto (rivaroxaban) to prevent blood clots and protect people from strokes. It is popular because it requires no blood testing and comes in a convenient once-a-day pill. But the drug may also cause irreversible internal bleeding that can lead to hospitalization and death. Unlike warfarin, a blood thinner that has been around for decades, Xarelto has no bleeding antidote.

Xarelto pill

Used to Treat: Reduction of stroke and blood clots in people with atrial fibrillation, blood clots in the legs and lungs, prevention of blood clots after knee or hip replacement surgery

Related Drugs: Eliquis, warfarin, Pradaxa, Savasaya

Manufacturer: Bayer and Janssen Pharmaceuticals (Johnson & Johnson)

Side Effects & Risks: Uncontrolled bleeding, muscle pain, numbness or tingling, liver problems, sinus problems

FDA Approval: 2011

View Lawsuit Information

*Please seek the advice of a medical professional before discontinuing the use of this drug.

Xarelto (rivaroxaban) is one of the newest anticoagulants — more commonly known as blood thinners. The Food and Drug Administration (FDA) originally approved Xarelto in 2011. The drug is an oral medication developed by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals. It belongs to a class of medications known as Factor Xa inhibitors.

Since Xarelto’s FDA approval, its sales have skyrocketed. In 2016, the drug made $2.2 billion for Bayer and Janssen, according to Johnson & Johnson’s annual report.

Xarelto 2016 Earnings topped $2b

Doctors prescribe it for patients who have had knee or total hip replacement surgery to reduce the risk of blood clots and  for people with atrial fibrillation (AF) to reduce the risk of stroke. Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

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.

Blood thinners prevent dangerous blood clots that can obstruct the blood flow to the vital organs. But they can also cause uncontrolled bleeding and other dangerous side effects. Because Xarelto has no antidote, some of these bleeds may be fatal.

How Does Xarelto Work?

Xarelto works by affecting a specific protein in the blood called Factor Xa that normally starts the clotting process. By blocking Factor Xa, Xarelto stops the production of a clotting enzyme called thrombin and prevents clots from forming.

It can take as long as 24 hours for the drug to be flushed out of the system. Older adults have a more difficult time flushing the drug, and the anticoagulation effect lasts longer in their bodies.

What are Side Effects of Xarelto?

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, also called 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 hip and knee replacement patients. These complications can be severe and require additional surgery to treat. Overall, seniors have the highest risk of side effects.

Side effects of Xarelto include:

  • Fainting
  • Numb or tingling muscles
  • Itching
  • Pain in one’s arms or legs
  • Muscle pain
  • Loss of ability to control movement
  • Abnormal liver function
  • Reduced platelet levels
  • Prolonged wound bleeding
  • Sinus irritation, congestion
  • Jaundice
  • Low white blood cell count
  • Hemorrhaging
  • Bleeding from the rectum
  • Intestinal or abdominal bleeds
  • Bleeding in the brain
  • Muscle spasms
  • Difficulty breathing or swallowing
  • Back pain
  • Dizziness Headache
  • Leg weakness
  • Bladder or bowel dysfunction
  • Painful urination
  • Allergic reaction
  • Stevens-Johnson syndrome

Xarelto’s Most Dangerous Side Effect: Internal Bleeding

Bayer and Johnson & Johnson advertise that Xarelto is safe and more convenient than warfarin, but taking the drug leaves users vulnerable to internal bleeding that can be fatal.

In 2014, the Institute for Safe Medicine Practices (ISMP) reported that 3,331 people suffered adverse events from Xarelto. Of these people, 1,647 suffered hemorrhagic bleeding.

Xarelto users suffer hemorrhagic bleeding

While the risk of bleeding exists with all blood thinners, Xarelto may be more dangerous because it does not have an antidote or reversal agent. Dialysis is also ineffective for flushing out the drug from the system. In contrast, warfarin, one of the oldest blood thinners, may also cause bleeding, but ER doctors can use a vitamin K antidote to stop the bleeding. Warfarin also has a few other options that help stop bleeds.

People who ended up in the hospital with severe or fatal bleeds filed lawsuits against Bayer claiming the company released a dangerous drug and misled the public about its safety. According to one lawsuit, a man died of parenchymal hemorrhage, a brain bleed. Because he was on Xarelto, ER doctors could not stop the bleeding.

Serious Xarelto Bleeding Symptoms

Xarelto’s manufacturers have yet to release information for doctors on how to treat bleeding complications, making it difficult for ER doctors to save patients. There are a few symptoms to look out for that could indicate bleeding problems and should be brought to a doctor’s attention immediately. Patients in poor health or over age 65 are more likely to suffer serious bleeding problems that can be fatal.

Seek medical attention right away if you experience any of the following:

  • Frequent nose bleeds
  • Unusual bleeding in the gums
  • Red, pink or brown urine
  • Severe uncontrolled bleeding
  • Bright red or black stool that looks like tar
  • Vaginal bleeding or menstrual bleeding that is heavier than normal
  • Wounds with pain, swelling or new drainage at the site
  • Coughing up blood or blood clots
  • Headaches, feeling weak and dizzy
  • Blood in vomit or vomit that looks like “coffee grounds”

Reducing Xarelto Bleeding Risk

According to NPS MedicineWise — a nonprofit health care organization — patients can take precautions to minimize the risk of Xarelto bleeding.

Precautions include:

  • Seeking emergency help for any signs of bleeding such as coughing blood, blood in urine or a bruise after a fall that isn’t healing
  • Reporting any falls to a doctor, even if there are no signs of bleeding
  • Avoiding activities that can cause injury such as contact sports, wearing protection when handling sharp objects and using an electric shaver
  • Disclosing all medications to doctors; some may increase bleeding risk

Letting health providers know about Xarelto use prior to surgeries or dental procedures.

Wound Infections and Leakage after Hip or Knee Replacements

In addition to severe bleeding, Xarelto is also linked to serious wound infections and leakage. Some orthopedic surgeons observed that patients who take Xarelto after hip- or knee-replacement surgery may end up back in the operating room because of severe infections at the implant site. Surgeons had to remove implants and patients had to undergo intense antibiotic therapy for weeks and even months.

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.

Xarelto users have 4x 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 patients had “large, fresh wounds.” 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.

FDA Black Box Warning and Precautions

Since the FDA approved Xarelto in 2011, the agency made several changes to the medication’s label. Some of the most important warnings are listed here. Check the most recent Xarelto label for all updates.

History of Warnings

August 2013

The FDA added a black box warning for increased risk of blood clots if Xarelto is stopped prematurely. In August 2013, the U.S. Food and Drug Administration (FDA) added a black box warning — its most severe label warning — for dangerous spinal bleeds called epidural or spinal hematomas. Hematomas are pools of blood that occur outside of blood vessels. Blood pooling in the spine can cause permanent paralysis.

People are at greater risk if they:

  • Use epidural catheters
  • Use other drugs that can affect the clotting process, such as NSAIDs or platelet inhibitors
  • Have a history of spinal trauma
  • Have a history of spinal surgery

The warning also cautions against any spinal procedures in patients who take Bayer’s drug. In March 2014, it updated the warning to add more information for health care providers on limiting the risk of spinal bleeding. Some procedures that may put patients at risk include spinal taps, spinal punctures, epidurals and any kind of spinal injections.

January 2014

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.

December 2014

The FDA added thrombocytopenia (platelet deficiency) and hepatitis under the list of postmarketing adverse reactions.

May 2016

Taking Xarelto with selective serotonin reuptake inhibitor (SSRI) and serotonin norepinephrine reuptake inhibitor (SNRI) antidepressants may increase the risk of bleeding.

Xarelto Dosage Recommendations

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:

  • 10 mg for 12 days for knee replacements
  • 10 mg for 35 days for hip replacements
  • 15 mg twice a day for 21 days, then 20 mg once a day for Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)
  • 15-20 mg per day for reducing the risk of stroke in nonvalvular Atrial Fibrillation (AF), irregular heartbeat.

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.

Xarelto Dosage for Children and Pregnant Women

There are no safety studies for children and pregnant women. Clinical trials are currently underway to determine if Xarelto is safe and effective in patients 18 years old or younger. One 2012 study in Thrombosis Research by Ignjatovic et al. showed the drug is effective to treat blood clots in children, but the dose must be tailored to the patient and more studies are needed for infants.

Pregnant women should use the medication with caution in case of hemorrhage or emergency delivery. Because Xarelto has no antidote, women in high-risk pregnancies may be at increased risk for severe blood loss.

Xarelto Drug Interactions

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.

Asprin being poured from bottle into hand

The following drugs could increase bleeding risk:

  • Warfarin (Jantoven, Coumadin)
  • NSAIDs (ibuprofen, Advil, Aspirin, Aleve, naproxen)
  • Any medicine that contains heparin
  • Plavix (clopidogrel)
  • SSRIs (Zoloft, Prozac) and SNRIs (Effexor)
  • Other drugs for blood clots

Other drugs that may adversely react with Xarelto include:

  • Carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol)
  • Indinavir (Crixivan)
  • Itraconazole (Onmel, Sporanox)
  • Ketoconazole (Nizoral)
  • Lopinavir/ritonavir (Kaletra)
  • Phenobarbital (Solfoton)
  • Phenytoin (Dilantin-125, Dilantin)
  • Rifampin (Rifater, Rifamate, Rimactane, Rifadin)
  • Ritonavir (Norvir)
  • St. John’s wort (Hypericum perforatum)

Xarelto (rivaroxaban) vs. Other Blood Thinners

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. In clinical trials, researchers compare the newer drugs to warfarin for effectiveness and safety. These are some of the most popular blood thinners and how they compare to Xarelto.

Pradaxa

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.

Before the FDA developed a Pradaxa bleeding antidote called Praxbind in 2015, the drug contributed to a number of fatal bleeds. Boehringer-Ingelheim spent hundreds of millions to settle thousands of bleeding lawsuits linked to the medication.

Coumadin (warfarin)

For decades, warfarin — also known by the brand names Coumadin and Jantoven — was the standard of care for preventing blood clots. Unlike 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.

Warfarin Tablet

 

Eliquis

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 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 (rivaroxaban)

Date Approved : 2011

Cost per year : About $5,000

Approved to Treat : Prevention and treatment of blood clots in lungs and legs. Prevention of blood clots after hip or knee replacement surgery. Reduction of stroke risk with nonvalvular atrial fibrillation.

Serious Side Effects : Risk of serious or fatal bleeding, spinal hematoma in patients undergoing spinal puncture, pregnancy-related hemorrhage

Bleeding Antidote : No

Coumadin (warfarin)

Date Approved : 1954

Cost per year : About $200

Approved to Treat : Prevention and treatment of blood clots in lungs and legs with or without atrial fibrillation with to without cardiac valve replacement. Reduce risk of death, recurrent heart attack and blood clots or stroke.

Serious Side Effects : Risk of serious or fatal bleeding, dietary changes can affect medication effectiveness, tissue necrosis, may cause fetal harm when taken during pregnancy

Bleeding Antidote : Yes, several

Pradaxa (dabigatran)

Date Approved : 2010

Cost per year : About $2,500

Approved to Treat : Reduce risk of stroke and blood clots with nonvalvular atrial fibrillation.

Serious Side Effects : Risk of serious or fatal bleeding, gastrointestinal adverse reactions

Bleeding Antidote : Yes

Eliquis (apixaban)

Date Approved : 2012

Cost per year : About $2,500

Approved to Treat : Prevention and treatment of blood clots in lungs and legs. Prevention of blood clots after hip or knee replacement surgery. Reduction of stroke risk with nonvalvular atrial fibrillation.

Serious Side Effects : Risk of serious or fatal bleeding, spinal hematoma in patients undergoing spinal puncture

Bleeding Antidote : No

Plavix (clopidogrel)

Date Approved : 1997

Cost per year : About $4,800

Approved to Treat : Prevent thrombotic cardiovascular events such as blood clots in patients with acute coronary syndrome.

Serious Side Effects : Significant and fatal bleeding, intracranial bleeding, not recommended in patients 75 or older, coronary artery bypass graft surgery-related bleeding

Bleeding Antidote : Yes

Brilinta (ticagrelor)

Date Approved : 2011

Cost per year : About $2,400

Approved to Treat : Reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI).

Serious Side Effects : Serious or fatal bleeding, coronary artery bypass graft surgery-related bleeding, do not take with aspirin dose above 100 mg, not for use in patients with history of intracranial hemorrhage

Bleeding Antidote : No

Savaysa (edoxaban)

Date Approved : 2015

Cost per year : About $4,080

Approved to Treat : Reduce risk of stroke and blood clots with nonvalvular fibrillation Treatment of blood clot in lungs (pulmonary embolism) and legs (deep vein thrombosis)

Serious Side Effects : Risk of serious or fatal bleeding, spinal hematoma in patients undergoing spinal puncture

Bleeding Antidote : No

Author

Michelle Y. Llamas is a senior content writer and researcher for Drugwatch. She is also the host of the Drugwatch Podcast where she talks to patients, experts and advocates about drugs, medical devices and health. She uses her technical writing experience to provide easy-to-understand information on how drugs and devices work. But she also tells people what happens when products that are supposed to improve their lives can hurt them.

View Sources
  1. Neale, T. (2014, January 16). Third strike for Xarelto for ACS. Retrieved from http://www.medpagetoday.com/Cardiology/AcuteCoronarySyndrome/43845
  2. NPS Medicinewise. (2013). Side effects of rivaroxaban, Retrieved from http://www.nps.org.au/medicines/heart-blood-and-blood-vessels/anti-clotting-medicines/for-individuals/anticoagulant-medicines/for-individuals/active-ingredients/rivaroxaban/for-individuals/side-effects
  3. Brighton, T. (2010). New oral anticoagulant drugs mechanism of action. Retrieved from http://www.australianprescriber.com/magazine/33/2/38/41
  4. National Library of Medicine. (2014). XARELTO (rivaroxaban) tablet, film coated. DailyMed. Retrieved from http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610
  5. Packel, D. (2014, February 20). J&J Blood thinner Xarelto caused bleeding, suit says. Law360. Retrieved from http://www.law360.com/articles/511660/j-j-blood-thinner-xarelto-caused-bleeding-suit-says
  6. Palmer, E. (2014, June 16). Sources: Bayer, J&J's Xarelto faces first U.S. lawsuits. FiercePharma. Retrieved from http://www.fiercepharma.com/story/sources-bayer-jjs-xarelto-faces-first-us-lawsuits/2014-06-16
  7. ISMP. (2015). Annual report. Retrieved from https://www.ismp.org/QuarterWatch/pdfs/2014Q4.pdf
  8. Mahendra, P. (2012, August 16). Rivaroxiban effective in children. Retrieved from http://www.news-medical.net/news/20120816/Rivaroxaban-effective-in-children.aspx
  9. Pierson, R. (2012, June 14). Insight: Top heart doctors fret over new blood thinners. Reuters. Retrieved from http://www.reuters.com/article/2012/06/14/us-drugs-bloodthinners-idUSBRE85D06G20120614
  10. Ansell, J. (2007). Factor Xa or thrombin: is factors Xa a better target? Journal of Thrombosis and Heamostasis, 5 (Suppl. 1): 60–4.
  11. U.S. Food and Drug Administration. (2012, November 2). FDA expands use of Xarelto to treat, reduce recurrence of blood clots. [Press release]. Retrieved from http://www.fda.gov/
  12. Nguyen, A. (2012, May 29). Advisory panel recommends against anticoagulant drug approval. Wolters Kluwer Law and Health. Retrieved from http://health.wolterskluwerlb.com/2012/05/advisory-panel-recommends-against-anticoagulant-drug-approval/
  13. EMC. (2012). Xarelto 10 mg film-coated tablets. Retrieved from http://www.medicines.org.uk/emc/medicine/21265/SPC/Xarelto+10+mg+film-coated+tablets/#UNDESIRABLE_EFFECTS
  14. Freeman, D. (2011, November 4). Xarelto okayed by FDA for treating atrial fibrillation. CBS News. Retrieved from http://www.cbsnews.com/news/xarelto-okayed-by-fda-for-treating-atrial-fibrillation/
  15. Janssen Pharmaceuticals. (2012). Xarelto. Retrieved from https://www.xarelto-us.com/
  16. Agency for Healthcare Research and Quality. (2015). Blood thinner pills: Your guide to using them safely. Retrieved from http://www.ahrq.gov/patients-consumers/diagnosis-treatment/treatments/btpills/btpills.html
  17. National Heart, Lung, and Blood Institute. (2014). How is atrial fibrillation treated? Retrieved from http://www.nhlbi.nih.gov/health/health-topics/topics/af/treatment
  18. U.S. National Library of Medicine. (2016). LABEL: XARELTO- rivaroxaban tablet, film coated. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610#s5.1
  19. Hughes, S. (2013, January 18). Apixaban Approved: Now Which Anticoagulant to Use? Retrieved from http://www.medscape.com/
  20. Jameson, S.S. et al. (2012). Wound complications following rivaroxaban administration: a multicenter comparison with low-molecular-weight heparins for thromboprophylaxis in lower limb arthroplasty. Journal of Bone and Joint Surgery. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/22832942
  21. Stanton, T. (2012). Switch to Rivaroxiban Led to Higher Complication Rate. American Academy of Orthopaedic Surgeons. Retrieved from http://www.aaos.org/News/The_Daily_Edition_of_AAOS_Now/2012/Wednesday,_February_8/AAOS17_2_8/?ssopc=1
  22. Brimmo, Olubusola, et al. Rivaroxaban use for Thrombosis Prophylaxis is Associated with Early Periprosthetic Joint Infection. Retrieved from http://www.arthroplastyjournal.org/
Free Xarelto Case Review