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Xarelto: Its Greatest Benefits and Worst Threats

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Rivaroxaban is a popular anti-coagulant drug that was approved by the US Food and Drug Administration (FDA) in July 2011 for people suffering from: atrial fibrillation (an irregularity in heart beat); deep vein thrombosis (DVT), also known as deep venous thrombosis, which refers to the formation of blood clots (or thrombus) in deep veins, mainly in the legs; and, pulmonary embolism, which is blood clot in the lungs. It is mainly intended to prevent harmful blood clots from forming, avoid chances of blood clots from recurring and reduce possible risks of stroke in people who have just undergone surgery for total hip replacement or knee replacement. In the US, and in some other countries, Rivaroxaban is sold under the generic name Xarelto and it is jointly produced by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) and Bayer Health Care.

Xarelto is a new generation blood thinner that is formulated to act as a direct thrombin inhibitor (DTI), to block thrombin from ever forming (thrombin are blood plasma enzymes that cause the blood to clot). Like Pradaxa, another DTI that was approved by the FDA in 2010 and which Xarelto was intended to compete against, Xarelto has been highly commended by pharmaceutical companies and doctors due to its formulation that no longer necessitates frequent testing of blood or diet and exercise monitoring which Warfarin, the anticoagulant drug that has dominated the market since 1954, requires.

Unlike Pradaxa, however, which directly blocks the production of thrombin, Xarelto directly attacks and inhibits the production of Factor Xa, the protein necessary in thrombin formation. Furthermore, Xarelto has been proven as very effective in the:

  • Reduction of risks of stroke in non-valvular atrial fibulation
  • Treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT)
  • Prevention of DVT following a knee replacement or hip replacement surgery
  • Reduction of DVT and PE recurrence

Despite its effectivity, Xarelto was discovered as not without adverse effects, some of which even fatal, thus, enough reason for the FDA to mandate a black box warning label to the drug’s packaging. One agency that keeps track of problematic or defective drugs is the Institution for Safe Medication Practices (ISMP), a nonprofit consumer watchdog organization. Based on ISMP data Xarelto’s adverse effects, which thousands of patients have already complained of, include: internal bleeding (including bleeding in the abdomen, intestines and rectum); blood clots; epidural or spinal hematomas (a condition wherein blood collects outside the blood vessels in the spinal cord area – this increases the risk of permanent paralysis); brain hemorrhaging; uncontrollable bleeding (to which there is no known remedy); blood in the urine and/or stool; severe nosebleeds; vomiting of, and coughing up, blood; stroke; and, risk of heart problems following discontinuation.

Millions of patients had already been prescribed with Xarelto despite its being new in the market. In fact, currently, Xarelto is the number one blood thinning medication in the US. But (in 2012) even before topping market sales (where blood thinning drugs are concerned) about 2081 serious adverse events (151 of these were fatal) had already been reported to the FDA.

It is hard to say exactly how many lawsuits have already been filed against the manufacturers of Xarelto as the lawsuits are based on different issues, like wrongful death, brain hemorrhaging, uncontrolled bleeding, and so forth. One thing is sure, though, that is, if you or anyone in your family or anyone you know is gravely suffering from any of the adverse effects caused by Xarelto, then it may be a good idea to contact the Xarelto lawsuit lawyers at the National Injury Law Center.

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