What is Xarelto?
What Is Xarelto
Xarelto (rivaroxaban) is an oral prescription medication that is a blood thinner (anticoagulant) with a different mechanism of action from older drugs. Blood thinners are used to prevent dangerous blood clots which can block the flow of blood to the important tissues and organs of the body. Unlike older blood thinners, where doctors had to customize the dose of the drug for each patient, Xarelto is prescribed in one uniform dose because of its different mechanism of action
- The Food & Drug Administration (FDA) has approved the marketing of Xarelto for the following uses:
- Xarelto can be prescribed to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- Physicians can use Xarelto for the treatment of deep vein thrombosis
- Xarelto is approved in the treatment of pulmonary embolism
- For patients who have been treated for 6 months for deep vein thrombosis and/or pulmonary embolism, Xarelto is
indicated for the reduction in the risk of recurrence for those conditions
- For patients undergoing knee or hip replacement surgery, doctors can use Xarelto for the prophylaxis of deep vein thrombosis
The FDA has concluded that Xarelto increases the risk of bleeding, which in some cases can lead to death. This bleeding will continue as long as Xarelto is in the body. If bleeding happens at or near a major organ such as the brain or kidneys, that loss of blood can result in a permanent loss of function. The side effect profile is one of the factors in the Xarelto lawsuit. When certain types of anesthesia is used, patients treated with Xarelto for prevention of thromboembolic events are at risk of developing a spinal hematoma which in some cases can result permanent paralysis. Xarelto should not be used in patients where the kidneys are not functioning fully because expected increase in Xarelto exposure and the increased risk of bleeding. In pregnant women, Xarelto should only be considered if the potential benefit justifies the potential risk of increased bleeding to the mother and fetus.
There is no known antidote for Xarelto. In addition, when a problem arises the drug cannot be flushed out of the body through dialysis. Many patients who have uncontrolled bleeding have to be up hospitalized, and that bleeding can be fatal. That the drug maker released a drug before an antidote was available is another factor in the Xarelto lawsuit.
Use of some drugs while taking Xarelto can cause an elevation of Xarelto in the blood stream which can cause an increase risk of bleeding. Some of these drugs include: ketoconazole, ritonavir, clarithromycin, erythromycin and fluconazole. In clinical studies with concomitant use, the increases in Xarelto exposure ranged from 30% to 160%. On the other hand, drugs such as rifampicin and phenytoin can decrease Xarelto blood levels by up to 50%. These decreases in blood levels of Xarelto may decrease efficacy. Concomitant use of Xarelto and anticoagulants, NSAIDS/aspirin may significantly increase the risk of internal bleeding. For patients with impaired renal function, concomitant use of drugs diltiazem, verapamil, dronedarone, and erythromycin) can have increased blood levels of Xarelto. Significant increases in Xarelto blood levels may increase bleeding risk.