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Xarelto — rivaroxaban — is an anticoagulant. Doctors may prescribe it to reduce your risk of deep-vein thrombosis and pulmonary embolism, especially following knee or hip replacement surgery.
If you have atrial fibrillation, Xarelto may be prescribed to prevent strokes and other clotting events that could be harmful to your health.
Xarelto belongs to a class of anticoagulants known as Factor Xa inhibitors. These prescription drugs work by suppressing your body’s natural production of thrombin in order to prevent blood from clotting.
However, taking Xarelto can cause potentially dangerous side effects, including death, due to its ability to cause severe bleeding events.
Critical Complications of Xarelto
In 2014, the U.S. Food and Drug Administration required additional language for Xarelto’s package labeling to warn you about the risks of bleeding events. These could happen if you abruptly stop taking this drug.
Growing scientific evidence and an increasing number of adverse events reported to the FDA strongly suggest Xarelto is unsafe and can raise your risk of:
- Brain hemorrhage
- Hemorrhagic stroke
- Gastrointestinal bleeding
- Pericardial (sac encasing the heart) bleeding
- Pulmonary (lungs) bleeding
- Intraocular (eye) bleeding
- Fatal internal bleeding after trauma
These events can be life threatening since there is no antidote for Xarelto to stop the bleeding. Antidotes do exist for older types of anticoagulants.
There are warnings in the Xarelto label regarding use by some kidney patients, pregnant women, nursing mothers and patients with prosthetic heart valves.
Xarelto Clinical Trial Validity Questioned by FDA
According to a Feb. 2015 study published in the Journal of the American Medical Association, many drug manufacturer clinical trial studies were cited as underreporting adverse events and other serious breaches of ethical and clinical protocols.
Some of the studies were also negligent in adhering to research protocols, properly ensuring patient rights, safety and welfare, and inadequate or inaccurate record-keeping, all of which may affect outcomes of data from these trials.
The studies examined included one on the safety and efficacy of Xarelto given to prevent blood clots in patients who had recently undergone hip and knee arthroplasty. Half of the FDA inspections of the Xarelto clinical trial sites for this study were rated “official action required,” the most serious FDA inspection classification. The violations warranted regulatory action.
The results from this RECORD 4 study (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep-Venous Thrombosis and Pulmonary Embolism) were considered unreliable by the FDA because of these violations. The FDA cited alarming practices, including discarding medical records and falsifying data.
The manufacturer of Xarelto did not mention these serious citations in the articles that were submitted to prestigious journals for publication about the purported efficacy and safety of taking the drug.
These findings are troubling, and this lack of transparency raises questions about the validity of clinical trial data generally, and could have alarming implications regarding the risks that accompany taking medications.
Symptoms of Xarelto Bleeding Injuries
Symptoms of internal bleeding caused by Xarelto can include any or all of the following, depending in part on where exactly the bleeding is occurring and how heavy the flow of blood:
- Blacking out
- Slurred or disoriented speech
- Facial droop
- Disorientation or trouble understanding speech
- Seizures, especially if you have not had them before
- Massive, sudden headache
- Neck pain
- Vomiting, bright red or containing black particles
- Rapid pulse
- Low blood pressure
- Weakness, shakiness or sudden paralysis
- Vision loss, sudden changes or sensitivity to light
- Tar-like stools, black or bright red
If you or a member of your family suffers any of these complications after taking Xarelto, you may need to seek a legal remedy to help you pay the costs of emergency and long-term medical treatment, as well as to help you recover for pain and suffering.
Reoperation Due to Xarelto Wound Complications
When Xarelto causes wound complications, it can be necessary to treat these complications by returning the patient to the operating room for additional surgery.
A study involving 1,048 patients who underwent total hip or knee replacement surgery found that 31 of them had wound complications, some of which required patients to go back under the knife. Of that 31, only nine had received a low molecular weight heparin prior to the original surgery. The remaining 22 had all received Xarelto. The researchers indicated that this difference was statistically significant.
The most typical wound complications accompanying Xarelto’s use after total hip or knee replacement include:
- Throbbing ache emanating from the wound site
- Oozing at the wound site
- Persistent wound drainage
- Inability to move through the full range of motion
The possibility of wound complications presents itself when Xarelto is given after arthroplasty — either a total hip or knee replacement or revision — due to its indication to reduce the risk of deep-venous thrombosis or pulmonary embolism.
Articles published in peer-reviewed journals indicate that wound complication rates are generally higher among arthroplasty patients who receive prophylactic doses of Xarelto than among those who instead receive low-molecular-weight heparin or other means of thromboprophylaxis, such as aspirin and compression stockings, and DVT compression pumps.
In one study, a cohort of patients who were given rivaroxaban after undergoing arthroplasty experienced slightly over one-third more wound complications than did patients who instead were given low-molecular-weight heparin after surgery.
In another study, there were an astonishing 250 percent more wound complications among those given post-arthroplasty rivaroxaban than among those given low-molecular-weight heparin.
In an editorial published in The New England Journal of Medicine in 2008, an orthopedic surgeon on the Steering Committee for a clinical trial for rivaroxaban concluded that based on these potential complications he would not recommend Xarelto for his hip and knee arthroplasty patients.
In a study recently published in The Journal of Arthroplasty, Dr. Olubusola Brimmo at the University of Missouri and colleagues from the Cleveland Clinic examined the effects rivaroxaban had on the incidence of deep surgical site infections that occurred within a month after total hip or knee arthroplasty. One group of patients received Xarelto. The second group received other types of medications including enoxaparin, aspirin and warfarin. Patients who received Xarelto carried a 10-times greater relative risk of infection than those who received other types medications to prevent blood clots.
How Weitz & Luxenberg Can Help
As a nationally recognized personal-injury law firm, Weitz & Luxenberg is committed to helping clients win cases. For more than 25 years, we have dedicated ourselves to holding wrongdoers accountable, and have obtained for our clients more than $17 billion in verdicts and settlements.
In fact, our Ellen Relkin, of counsel attorney at W&L, is helping to lead the lawsuit against the makers of Xarelto by serving on the 12 member court-appointed Plaintiff’s Steering Committee?.
Assisting you would be a privilege. For a free consultation and more information about your legal options, please call us at (877) 625-5927. If you prefer, you can complete our online form and one of our client relations representatives will shortly afterward contact you.