The blood thinner Xarelto is prescribed to prevent blood clots. Due to its effectiveness in hindering the blood coagulation process, and convenience as a daily pill, Xarelto has become one of the most popular and profitable blood thinners on the market.
However, rivaroxaban, the active ingredient in Xarelto, has been shown to cause irreversible bleeding and other harmful side effects that may require urgent medical attention. Unlike warfarin, another common anticoagulant, there is currently no antidote to reverse the side effects of rivaroxaban. Because of the severe bleeding risk, the first Xarelto lawsuit went to trial on April 24, 2017.
What are the Side Effects of Xarelto?
Xarelto (rivaroxaban) works by inhibiting factor Xa, an enzyme that facilitates the blood coagulation process. A main advantage of the drug is that it works quickly, but this benefit also contributes to one of the more serious side effects – severe and uncontrollable bleeding.
Research has also shown that the medication may increase the risk of wound complications in patients who undergo lower-limb surgeries, and can cause blood clotting following spinal taps or epidurals.
Common Side Effects of Xarelto
If you experience any of the following severe symptoms after taking Xarelto, call your doctor or seek medical help immediately:
- Bloody, black, or tarry stools
- Red, pink, or brown urine
- Coughing up or vomiting blood or material that looks like coffee grounds
- Frequent nosebleeds
- Bleeding from gums
- Heavy menstrual bleeding
- Dizziness or fainting
- Blurred vision
- Pain in arm or leg
- Difficulty breathing or swallowing
- Pain or swelling at wound sites
Xarelto and Bleeding
When taking the anticoagulant Xarelto, patients tend to bruise easier, and minor cuts can become life-threatening because it takes so long to stop the bleeding. Symptoms such as vomiting or coughing up blood, red or black stool, and blood clots after a spinal tap or epidural are often red flags of what could be irreparable damage occurring within the body.
Heavy bleeding around the organs, including the kidneys and brain, can interrupt blood flow, restricting their function. Brain bleeds (known as parenchymal or intraparenchymal hemorrhages) are the most lethal result of this process.
You may have a higher risk of bleeding if you take Xarelto along with other medications that can increase your risk of bleeding, including:
- Aspirin or aspirin-containing products
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Warfarin sodium (Coumadin, Jantoven)
- Any medicine that contains heparin
- Clopidogrel (Plavix)
- Selective serotonin reuptake inhibitors (SSRIs) or serotonin
- Norepinephrine reuptake inhibitors (SNRIs)
- Other medicines to prevent or treat blood clots
More about drug interactions Questions You Should Always Ask Your Pharmacist
Xarelto and Blood Clots
While Xarelto is intended to help reduce the risk of blood clots, it can increase your risk of developing them in certain circumstances. For example, patients who receive a spinal anesthetic, also known as an epidural, or have a spinal tap may form a blood clot around their brain or spinal cord.
These clots are critically serious and may result in a stroke, damage throughout the body, and long-term or permanent paralysis. Your risk of developing epidural or spinal blood clots is higher if you:
- Have an epidural catheter in your back that administers medication
- Take NSAIDs or a medication to prevent blood from clotting
- Have a history of difficult or repeated epidural or spinal punctures
- Have a history of spinal problems or has undergone spinal surgery
Possible symptoms of spinal or epidural blood clots include tingling, numbness, muscle weakness, back pain, and uncontrollable bowels or bladder.
Also at an increased risk of developing blood clots are those with atrial fibrillation (an irregular heartbeat). Xarelto can potentially cause a blood clot in the heart that can travel to the brain (resulting in a stroke) or to other parts of the body.
Xarelto and Wound Complications
Just as Xarelto can turn a minor abrasion into an emergency situation, the drug can send a patient back to the operating room with complications after surgery for knee or hip replacement. Patients undergoing lower-limb arthroplasty are often given Xarelto as a prophylactic to prevent deep-vein thrombosis.
Read about safer knee and hip joints 3D-Printing Our Way to Safer Medical Devices
Several studies show that those who took the drug after their surgeries experienced wound complications, such as leakage and infection at the implant site, hematoma, and reduced range of motion far more often than those treated with heparin, aspirin, or other forms of thromboprophylaxis.
Investigation of Xarelto Side Effects
Following the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism (RECORD) 4 Study, orthopedic surgeon and member of the steering committee, Dr. Paul Lotke of the University of Pennsylvania, expressed concerns about the drug in his 2008 editorial in the New England Journal of Medicine. He wrote:
“Although rivaroxaban, as compared with enoxaparin, has been shown to have superior efficacy and reasonable safety, I would not recommend it for my patients. Like most anticoagulant studies, however, it did not measure the surgical outcomes, such as wound healing, drainage, infection, range of motion, and chronic pain.”
Since then, additional studies have raised even more concerns about the anticoagulant.
Timeline of Xarelto Side Effect Studies
A 2011 study followed 1048 patients who underwent total knee or hip replacement. 489 of these patients received low-molecular-weight heparin, and 559 who received Xarelto. Patients who received Xarelto as a thromboprophylaxis had a statistically significant increase in wound complications.
In 2012, researchers found significantly more wound complications in those taking Xarelto for lower-limb arthroplasty (3.85) compared to those taking low-molecular-weight heparin (2.81).
In 2013, a study found that seven of the 266 knee arthroplasty patients who received prophylactic doses of Xarelto experienced wound complications, including rupture, hematoma, and oozing, requiring them to return to the operating room.
In 2014, the Institute for Safe Medicine Practices reported that 3,331 people suffered adverse episodes from Xarelto, with 1,647 experiencing hemorrhagic bleeding.
A 2015 study revealed patients who took Xarelto after hip or knee replacement surgery had a risk of deep surgical-site infection of 10. when compared to those patients who received other types of thromboprophylaxis. The study examined 480 patients treated with other medications and 159 patients treated with Xarelto. Learn more about Xarelto
No Antidote for Xarelto Side Effects
One of the main concerns associated with the Xarelto and other similar anticoagulant drugs is that there is no antidote available.
The leading anticoagulant for decades has been warfarin. The side effects of this drug can be treated with vitamin K injections to encourage the blood to clot again. Patients taking Xarelto do not have that option, making bleeding more serious and potentially deadly.
Pharmaceutical companies are aware of the risks associated with Xarelto and have been working on a new drug that will serve as a reversal agent for anticoagulant drugs. Approval has been delayed by the FDA.
Read more about drug approvals How the 21st Century Cures Act Affects Drugs and Medical Devices
FDA Warnings about Xarelto Side Effects
Although the U.S. Food & Drug Administration (FDA) approved Xarelto in 2011, the agency has since found that the manufacturer Janssen Pharmaceuticals did not sufficiently warn consumers about the side effects. As such, the FDA has frequently changed the medication’s label with updated warnings. Here is a summary of those warnings:
Black-box warning added indicating an increased risk of for dangerous spinal bleeds called epidural or spinal hematomas, also advising against spinal procedures for those taking Xarelto.
Additional information for healthcare providers added about how to limit the spinal-bleeding risk.
Section added warning that Xarelto has no antidote and the drug is not to be used by patients with prosthetic heart valves.
Addition of postmarketing adverse reactions thrombocytopenia and hepatitis.
Warning added that SSRI and SNRI antidepressants may increase the risk of bleeding.
Xarelto Drug Interactions
Before taking Xarelto, it is imperative that you tell your doctor and pharmacist if you are allergic to any other medications, or to rivaroxaban or any of the other ingredients of Xarelto.
Xarelto can cause adverse effects due to interactions with certain medications, vitamins and supplements, such as blood thinners like such as aspirin or other NSAIDs, which can increase the risk of bleeding. Other drugs can affect how Xarelto works.
The Xarelto label warns patients to inform their doctors if they are taking any of the following medications or supplements:
- Carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol)
- Indinavir (Crixivan)
- Itraconazole (Onmel, Sporanox)
- Ketoconazole (Nizoral)
- Lopinavir/ritonavir (Kaletra)
- Phenytoin (Dilantin-125, Dilantin)
- Phenobarbital (Solfoton)
- Rifampin (Rifater, Rifamate, Rimactane, Rifadin)
- Ritonavir (Norvir)
- St. John’s wort (Hypericum perforatum)
- Antifungals: itraconazole (Sporanox), ketoconazole (Nizoral, Onmel)
- Barbiturates: phenobarbital (Solfoton™)
- Heart or blood pressure medications: reserpine, diltiazem (Cartia, Cardizem), dronedarone (Multaq), felodipine (Plendil), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan)
- HIV medications: ritonavir (Norvir, Kaletra)
- Seizure medications: carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin) or primidone (Mysoline)
- Salicylates: aspirin, Nuprin, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate and others
Whether or not you are taking other medications, always speak to your doctor before taking Xarelto.
Lawsuits Over Xarelto Side Effects
Uncontrollable bleeding and other side effects of have lead to a number of Xarelto lawsuits being filed against Janssen Pharmaceuticals and its parent company, Johnson & Johnson—also the subject of baby powder lawsuits over it’s talcum powder products. The first bellwether case began in May 2017 in Louisiana, and thousands other cases have been filed in courts all around the country.
If you or a loved one have experienced severe injury or death due to unstoppable bleeding after taking Xarelto, you may be eligible to receive compensation. Read more about Xarelto lawsuits