Doctors prescribe Xarelto to prevent blood clotting. Xarelto has caused major internal bleeding in some patients.
What is Xarelto?
Xarelto (rivaroxaban) is an anticoagulant, or blood thinner, that prevents blood clots. Bayer AG and Johnson & Johnson developed Xarelto. They marketed it as a more convenient alternative to other anticoagulants, which require frequent dose adjustments and a specific diet. Xarelto is a simple tablet taken by mouth. It comes in 15 mg or 20 mg dosages that require few adjustments.
Xarelto is an alternative to warfarin, the standard anticoagulant for over 50 years. Now Xarelto is part of a billion dollar market of newly developed anticoagulants.
Doctors prescribe Xarelto for the following conditions:
- Atrial fibrillation (AF) – AF is an irregular heartbeat that inhibits blood flow. Poor blood flow can lead to clots in the heart, which can be life-threatening. These clots can also travel to the brain and cause a stroke.
- Knee and hip replacements – After surgery for a knee or hip replacement, people are at a greater risk of developing blood clots. Blood clots can form after these surgeries due to inactivity.
- Deep vein thrombosis (DVT) – This is a blood clot in the body’s deep veins. DVT usually occurs in the legs, especially after periods of inactivity. DVT can develop after knee and hip replacements. Some patients at risk for deep vein thrombosis include: lupus patients, patients recovering from a deep injury, and seniors above the age of 60.
- Pulmonary embolism (PE) – PE is a blood clot in the lung’s major arteries. These clots typically travel from other parts of the body. DVT blood clots can cause a pulmonary embolism.
In 2011, the U.S. Food and Drug Administration (FDA) approved Xarelto for people who have hip and knee replacements or AF. A year later, the FDA approved Xarelto for DVT and PE. Despite the FDA’s approval, doctors have expressed concerns about the risks of bleeding in those taking the drug.
How does Xarelto work?
Doctors prescribe Xarelto to increase blood flow and lower the risk of clotting and stroke. Xarelto increases blood flow by thinning the blood. In order to thin the blood, Xarelto blocks a blood clotting enzyme called Factor Xa.
Coagulation is a normal process that prevents blood loss from damaged blood vessels. The blood at the damage site clots together to stop bleeding. But if a person’s blood is too thin from taking Xarelto, they can experience internal bleeding. In some cases, people have experienced major bleeding episodes and death from taking Xarelto.
If you have concerns about taking Xarelto, do not stop taking it without talking to your doctor. Suddenly stopping Xarelto can lead to dangerous blood clots.
SIDE EFFECTS of XARELTO
Xarelto’s most dangerous side effect is severe, uncontrollable bleeding. Internal bleeding causes a loss of blood to major organs, which can cause these organs to malfunction or shut down. Internal bleeding caused by Xarelto can also lead to heart attack and brain damage. Major bleeding episodes occur most often in older patients.
Common Side Effects
- Back pain
- Shortness of breath
Serious Side Effects
- Coughing up blood
- Vomiting blood
- Discolored urine (red, pink, brown)
- Bright red or black stool
- Abnormal bleeding in the gums
Who is at Risk?
People shouldn’t take Xarelto if they have liver or kidney problems, history of stroke, recent surgery or bleeding problems. Even the manufacturers of Xarelto recognize that these people have a higher risk of death if they take the drug.
People taking Xarelto who have spinal or epidural injections are also at risk. These injections are often used for long-term treatment of back pain. For people who’ve had these injections, Xarelto can cause blood clots in the spine that may lead to paralysis.
Pregnant or breastfeeding patients shouldn’t take Xarelto.
Evidence of Xarelto Complications
Several studies have outlined the risks of Xarelto. Many complications can arise as a result of prescribing Xarelto to at-risk patients.
In 2015, a 64-year-old man died from a lung hemorrhage caused by Xarelto. He was prescribed the drug following a knee replacement.
A study published in 2015 found that doctors are prescribing Xarelto to more and more patients with kidney disease. However, patients with kidney disease are more likely to have potentially fatal bleeding. The authors of the study noted there is no evidence that the benefits of Xarelto for these patients outweigh the risks.
Drug Reactions with Xarelto
There are a variety of medicines, vitamins and supplements that can increase the risk of bleeding caused by Xarelto. People taking Xarelto must be cautious about taking any substances that can cause an adverse reaction. Even drinking alcohol while taking Xarelto can lead to serious bleeding.
The Mayo Clinic provides an extensive list of drugs that can cause reactions with Xarelto
Some of the drugs include:
- Clopidogrel (Plavix)
- Rifampin (Rifater, Rifamate, Rimactane, Rifadin)
- Itraconazole (Onmel, Sporanox)
- Ritonavir (Norvir)
- Carbamazepine (Carbatrol, Equetro, Tegretol, Teril, Epitol)
- Indinavir (Crixivan)
- Phenytoin (Dilantin)
- Lopinavir/ritonavir (Kaletra)
- Ketoconazole (Nizoral)
- Phenobarbital (Solfoton)
- St. John's wort (Hypericum perforatum)
Last Edited: March 15, 2017
- Xarelto. (2015). Janssen Pharmaceuticals, Inc. May 2016. https://www.xarelto-us.com/
- FDA. (2016). Xarelto MEDICATION GUIDE. May 2016. http://www.fda.gov/downloads/Drugs/DrugSafety/UCM280333.pdf
- Micromedex. (2016). Rivaroxaban (Oral Route). May 2016. http://www.mayoclinic.org/drugs-supplements/rivaroxaban-oral-route/description/drg-20075013
- Mayo Clinic Staff. (2015). Atrial fibrillation. May 2016. http://www.mayoclinic.org/diseases-conditions/atrial-fibrillation/basics/definition/con-20027014
- Mayo Clinic Staff. (2014). Deep vein thrombosis (DVT). May 2016. http://www.mayoclinic.org/diseases-conditions/deep-vein-thrombosis/basics/definition/con-20031922
- Mayo Clinic Staff. (2015). Pulmonary embolism. May 2016. http://www.mayoclinic.org/diseases-conditions/pulmonary-embolism/basics/definition/con-20022849
- Sandy Walsh. (2011). FDA approves Xarelto to prevent stroke in people with common type of abnormal heart rhythm. May 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm278646.htm
- Stephanie Yao. (2012). FDA expands use of Xarelto to treat, reduce recurrence of blood clots. May 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm326654.htm
- HealthDay. (2012). FDA Panel Votes Against New Use for Blood Thinner Xarelto. May 2016. http://health.usnews.com/health-news/news/articles/2012/05/24/fda-panel-votes-against-new-use-for-blood-thinner-xarelto
- Almashat, Carome, Wolfe. (2011). Public Citizens Health Research Group. May 2016. https://www.citizen.org/documents/1974.pdf
- Samuel P. Hammar. (2015). Fatal pulmonary hemorrhage after taking anticoagulation medication. May 2016. http://www.sciencedirect.com/science/article/pii/S2213007115000441
- Chan, Edelman, Wenger, Thadhani, Maddux. (2015). Dabigatran and Rivaroxaban Use in Atrial Fibrillation Patients on Hemodialysis. May 2016. http://circ.ahajournals.org/content/early/2015/01/16/CIRCULATIONAHA.114.014113.short
- Chung WS, Lin CL, Chang SN, Lu CC, Kao CH. (2014) Systemic lupus erythematosus increases the risks of deep vein thrombosis and pulmonary embolism: a nationwide cohort study. March 2017. https://www.ncbi.nlm.nih.gov/pubmed/24472157