Xarelto Side Effects Lawsuit
Xarelto side effects may range from problems with ulcers to severe internal bleeding and even death. If you have been injured as a result of Xarelto side effects you should contact our Xarelto lawyers regarding your possible Xarelto lawsuit.
Xarelto (Rivaroxaban) is a prescription medicine used that is used orally to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. Xarelto (Rivaroxaban) is a Direct Thrombin Inhibitor Anticoagulant aka blood thinning medicine.
Xarelto market approval was given by the FDA for medical use on July 1, 2011. Xarelto can reduce the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can cause blood clots to form, increasing your risk of a stroke. Xarelto lowers the chance of blood clots forming in your body. Xarelto is prescribed to replace other Anticoagulants (blood thinners) like Warfarin (Coumadin), which is what's predominantly used in the United States to treat blood clots.
Anticoagulants reduce blood clotting, which is why they are more commonly called blood thinners. Anticoagulants like Xarelto are most commonly used in patients with atrial fibrillation, or an irregular heartbeat. This is because atrial fibrillation increases the risk of stroke, which is many times higher in patients with an irregular heartbeat. About 130,000 prescriptions were written for Xarelto in the first three months of 2012. Xarelto and a similar drug called Pradaxa both cost around $3,000 per year, versus about $200 per year for Warfarin.
How Is Xarelto Different Than Traditional Blood Thinners?
Xarelto and warfarin work differently to help reduce the risk of stroke due to Afib not caused by heart valve problems. Xarelto is a direct thrombin inhibitor that helps to stop clots from forming by working directly on thrombin. Thrombin is the bloods central clotting agent. Thrombin works by causing certain materials in your blood to bind together to form a clot.
Warfarin is a vitamin K antagonist that help to stop clots from forming by interfering with vitamin K, a vitamin your body needs to form clots.
In addition to the usual side effects of other blood thinners, which can include excessive bleeding Xarelto bleeding side effects have no known reversal agent or Antidote. There is also no standard method to measure the anticoagulant effect of Xarelto.
Serious Xarelto Side Effects
Xarelto bleeding is one side effect, which can be serious and sometimes lead to death. This is because Xarelto is a blood-thinning medicine (anticoagulant) that lowers the chance of blood clots forming in your body. To find the best dose of Xarelto for you, your doctor should test your kidney function before you take your first dose of Xarelto, and in some instances yearly there after.
Xarelto is being marketed as an improvement to tradition anticoagulants such as Warfarin for patients that require frequent blood draws. However, there have already been reports of deaths and other serious life threatening Xarelto side effects reported since Xarelto was approved by the FDA. There has not to date been a Xarelto recall and the FDA nor the makers of Xarelto hinted that there is any reason to have Xarelto recalled.
What really compounds the issue with serious Xarelto side effects is the lack of a specific antidote to reverse life-threatening Xarelto bleeding.
Symptoms of Xarelto bleeding side effects may include:
- Unusual bruising or bleeding
- Pink or brown urine
- Red or black tarry stools
- Coughing up blood
- Vomiting that resembles blood or looks like coffee grounds
- Bleeding from the gums
- Frequent nose bleeds
- Weakness and swelling in the hands, arms, lower legs, ankles or feet
- Joint pain or swelling
There have been four major studies of Xarelto side effects called the RECORD studies which had a total enrollment of 120,000 patients. Overall the studies showed that oral Xarelto has non-inferior and possibly superior efficacy compared to 40mg per day of subcutaneous low molecular weight heparin (LMWH) enoxaparin in preventing venous thromboembolism in adult patients undergoing total hip replacement surgery or knee replacement surgery. However, the risk of serious bleeding or fatal bleeding was greater in patients randomized to Xarelto rather than enoxaparin and one patient randomized to Xarelto died of liver toxicity. The 4 parts of the RECORD studies include Record 1 and 2 (hip replacement) and Record 3 and 4 (knee replacement). The Record 4 study showed that although Xarelto was significantly more effective in reducing the occurrence of blood clots following knee surgery severe bleeding was twice as likely when Xarelto was used as opposed to enoxaparin. In a systematic review comparing Xarelto with dabigatran, apixaban and enoxaparin after a total hip replacement or a total knee replacement, the higher efficacy of Xarelto was associated with a much higher bleeding tendency.
The MAGELLAN study was initiated for prevention of venous thrombosis in hospitalized medically ill patients. The study showed that taking Xarelto (Rivaroxaban) 10mg once daily for 35 days was associated with a reduction in the risk of blood clots, compared with standard 10-day treatment with enoxaparin by subcutaneous injection, in acutely ill hospitalized medical patients. However, bleeding rates were significantly increased with Xarelto. By day 10 there were 5 patients that died from serious and uncontrollable Xarelto bleeding compared to only one death with enoxaparin. After 35 days of Xarelto use there were another 7 patients that died from serious and uncontrollable Xarelto bleeding compared to only 1 for enoxaparin.
In the Magellan study it was shown that Xarelto can be a single-drug approach to the short-term and continued treatment of blood clots and can also improve the benefit-to-risk profile of anticoagulation. Four patients in the Magellan study had major bleeding events, though they were non-fatal.
The ROCKET-AF trial, a Bayer company based double blind trial, comparing a once-daily, fixed dose of Xarelto with adjusted-dose warfarin in patients with non-valvular atrial fibrillation who were at moderate to high risk of stroke. Xarelto proved to be non inferior to warfarin in the prevention of subsequent stroke or systemic embolism. There were no significant differences in rates of major and clinically relevant non-major bleeding between the two study groups. Intra cranial bleeding and fatal bleeding occurred less frequently in the Xarelto group however bleeding from gastrointestinal sites, including upper, lower and rectal sites occurred more frequently in the Xarelto group, as did bleeding that led to a drop in hemoglobin levels or major bleeding that required a transfusion. An FDA reviewer of the ROCKET trial concluded that the ROCKET study results do not convincingly demonstrate the non-inferiority, much less the superiority of Xarelto to warfarin when the latter is skillfully used. A Xarelto black-box warning was issued in the US which warned of potential thrombosis issues that may occur if Xarelto treatment is discontinued and not replaced by another anticoagulant.
The ATLAS trial for secondary prevention of major cardiovascular events in patients with acute coronary syndrome shows for the 2.5mg twice daily dose of Xarelto a reduction in overall and cardiovascular mortality was accomplished vs. placebo, despite an increased risk of major Xarelto bleeding. The study was ended early due to early patient withdrawals and incomplete follow up. A meta-analysis concluded that new anticoagulants (anti-Xa or direct thrombin inhibitors) give a small benefit when added to dual anti platelet therapy in acute coronary syndrome, but an unacceptably high rate of serious bleeding.
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Xarelto Side Effects - Xarelto Bleeding & Xarelto Death
If you or a loved one have suffered serious side effects of Xarelto, Xarelto injury or death while using the anticoagulant Xarelto, you may be entitled to compensation. Contact the Xarelto side effects lawyers of Ennis & Ennis, P.A. today for a free nationwide case evaluation. Our experienced Xarelto attorneys can answer any questions you may have about Xarelto litigation, Xarelto side effects, a potential Xarelto lawsuit or even a possible Xarelto class action lawsuit. Fill out the Xarelto lawsuit case evaluation form on this page or call toll free: 1.800.856.6405.