Do you use Xarelto?

This medication is currently the subject of a legal inquiry, class-action lawsuit, or Mass Tort civil action. If you have been injured by this product, you may be entitled to compensation.

Xarelto (rivaroxaban)

Xarelto® is a blood thinner that treats and prevents blood clots and lowers the risk of stroke in patients who have atrial fibrillation. It is a prescription medication in the Direct Xa Inhibitor drug class available in 10mg, 15mg, and 20mg tablets. Currently, there is no generic version available in the United States.

Xarelto

Xarelto Recall

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Questions & Answers

  • Question

    bigshirley50

    Will Xarelto have any negative side effects on newborns and nursing mothers?

    posted on April 29, 2016
  • Question

    bigshirley50

    The medication can cause an increase in thrombotic occurrences.

    posted on April 29, 2016
  • Question

    bigshirley50

    What is the percentage of patients with spinal deformity that experience side effects as a result of taking Xarelto?

    posted on April 29, 2016
  • Question

    bigshirley50

    I was advised by my primary physician refrain from taking Warfarin will taking Xarelto.

    posted on April 29, 2016
  • Side Effects & Adverse Reactions

    The U.S. Food and Drug Administration-approved labeling for XARELTO (rivaroxaban) contains the following warnings and precautions:

    1. Increased risk of thrombotic events after premature discontinuation.

    A patient should not stop taking XARELTO or any anticoagulant pill unless an adequate alternative medication has been prescribed, the patient has completed prescribed therapy or the patient is suffering from a serious and potentially fatal bleeding episode. It should be noted that, in clinical trials involving patients with nonvalvular atrial fibrillation, an increased risk of stroke was observed as patients switched from XARELTO to warfarin.

    2. Risk of bleeding.

    XARELTO raises the risk of serious and potentially fatal bleeding events. In clinical trials, bleeding complications were the most commonly reported adverse reaction. A hemorrhage, or bleeding from ruptured blood vessels, is a type of a bleeding complication that can lead to stroke or death.The bleeding events reported in XARELTO clinical trials include:
    • Intracranial hemorrhage ñ Bleeding within the skull, or cranium, which may lead to brain cell/nerve damage, stroke or death. †Headaches, blurred vision, slurred speech, confusion and feelings of numbness, tingling or loss of control of one side of the body or face are signs of intracranial bleeding. Most XARELTO bleeding events involve this type of bleeding.
    • Intraspinal hemorrhage ñ Bleeding within the spinal cord may lead to paralysis. A patient using XARELTO should seek medical help if he or she experiences weakness or loss of sensation in the limbs or experiences difficulties with urination.
    • Gastrointestinal bleeding ñ Bleeding may occur in the upper (esophagus, stomach, upper portion of small intestine) or lower (large intestine, anus, rectum, bowels and lower portion of the small intestine) GI tracts. Signs of this bleeding include blood in the stool or urine, dark (tar-like) stool or vomiting blood (which looks like coffee grounds).
    Other types of bleeding events reported among XARELTO users in clinical trials are:
    • Intraocular (eye)
    • Pericardial (tissue surrounding the heart)
    • Intra-articular (joints)
    • Intramuscular (muscles)
    • Retroperitoneal (abdomen).
    There is no known antidote for XARELTO-related bleeding events such as the administration of vitamin K or protamine sulfate. A patient may need to wait between 5 to 9 hours for the medication to pass through oneís system. A doctor may order blood replacement, or a transfusion.

    3. Spinal/epidural anesthesia or puncture.

    Pooling of blood (hematoma) may occur when spinal or epidural anesthesia is administered to a patient who is using XARELTO. The result may be long-term or permanent paralysis. For this reason, use of the anesthesia or the use of an epidural catheter should only take place when the anticoagulant effect of XARELTO is at its lowest. Also, a patient should be closely monitored for complications that include:
    • Back pain
    • Numbness, tingling or weakness in the lower limbs
    • Loss of bowel or bladder function.
    If a spinal or epidural hematoma occurs, emergency treatment may be needed such as spinal decompression surgery, which will relieve pressure on the spine.

    4. Use in patients with renal impairment.

    The use of an anticoagulant such as XARELTO is a concern with a patient suffering from renal impairment due to the fact that a patient may experience a loss of kidney function (or the filtering of waste products from the blood). Acute renal failure may be fatal.

    5. Use in patients with hepatic impairment.

    A patient ís risk of experiencing a severe and potentially deadly bleeding episode while using XARELTO may be increased if the patient suffers from reduced functioning of the liver.

    6. Use with P-gp and strong CYP3A4 inhibitors or inducers.

    XARELTO should not be used by patients who are also taking medications that either reduce or increase certain enzymes, including:
    • Ketoconazole and itraconazole (commonly prescribed antifungal medications)
    • Lopinavir/ritonavir (a drug used to treat HIV infection)
    • Conivaptan (a medication used to treat low blood sodium levels)
    • Carbamazepine and phenytoin (anti-convulsants)
    • Rifampin (a tuberculosis medication)
    • St. Johnís wort (an herb often taken to treat depression).

    7. Risk of pregnancy-related hemorrhage.

    Doctors should fully weight the potential benefits of XARELTO use by pregnant women against the possible risks to the mother and fetus. In particular, the anticoagulant effect of XARELTO cannot be monitored through standard lab tests, and risks of severe bleeding may arise due to the inability to reverse the drugís anticoagulant effect.

    Patients with prosthetic heart valves.

    The FDA has approved the use of XARELTO for the treatment of patients with non-heart valve-related atrial fibrillation. The manufacturer warns that no study has been undertaken of how XARELTO affects patients with artificial heart valves.

    9. Acute pulmonary embolism in hemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

    XARELTO should not be administered to a patient with a blood clot in the lungs who is experiencing a significant drop in blood pressure and who will undergo emergency treatment for the condition.Sponsored by: Salvi, Schostok & Pritchard P.C.

    Legal Issues

    In recent years, Xarelto has been marketed as a convenient alternative to Coumadin (warfarin). Xarelto users are free of the need for regular blood testing and dietary restrictions, several TV and print ads have touted. However, many believe these ads have failed to adequately warn consumers of the risks associated with Xarelto, including the risk of serious and potentially fatal gastrointestinal hemorrhaging and other excessive internal bleeding. Additionally, unlike a warfarin user, no antidote such as vitamin K injections exists to help a Xarelto user who experiences a bleeding emergency.

    As a result, patients and those who have lost loved ones who were prescribed Xarelto have filed lawsuits in courts across the country against the companies behind Xarelto: Bayer HealthCare and Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson). The lawsuits tend to allege that the Xarelto manufacturers failed to properly warn patients and doctors of the potential internal bleeding risks (and lack of an antidote) associated with the blood-thinning medication.

    Individual Xarelto lawsuits that have been filed in federal courts have been transferred and consolidated in the U.S. District Court for the Eastern District of Louisiana. This helps to reduce the costs and time involved in pre-trial litigation.  Lawsuits are also being filed in state courts.

    The lawsuits are generally seeking compensatory damages (including compensation for all medical expenses) and punitive damages (which are meant to punish and deter grossly negligent or willful misconduct).


    FDA Safety Alerts

    There are currently no FDA safety alerts available for this drug.

    Manufacturer Warnings

    There is currently no manufacturer warning information available for this drug.

    FDA Labeling Changes

    There are currently no FDA labeling changes available for this drug.

    Uses

    There is current no usage information for this drug.

    History

    There is currently no drug history available for this drug.

    Other Information

    Rivaroxaban, a FXa inhibitor, is the active ingredient in XARELTO Tablets with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19H18ClN3O5S and the molecular weight is 435.89. The structural formula is: Chemical Structure Rivaroxaban is a pure Senantiomer. It is an odorless, non-hygroscopic, white to yellowish powder. Rivaroxaban is only slightly soluble in organic solvents (e.g., acetone, polyethylene glycol 400) and is practically insoluble in water and aqueous media.Each XARELTO tablet contains 10 mg, 15 mg, or 20 mg of rivaroxaban. The inactive ingredients of XARELTO are: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. Additionally, the proprietary film coating mixture used for XARELTO 10 mg tablets is OpadryÆ Pink and for XARELTO 15 mg tablets is OpadryÆ Red, both containing ferric oxide red, hypromellose, polyethylene glycol 3350, and titanium dioxide, and for XARELTO 20 mg tablets is OpadryÆ II Dark Red, containing ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide.

    Xarelto Manufacturers


    • Cardinal Health
      Xarelto (Rivaroxaban) Tablet, Film Coated [Cardinal Health]
    • Janssen Pharmaceuticals, Inc.
      Xarelto (Rivaroxaban) Tablet, Film Coated Xarelto (Rivaroxaban) Kit [Janssen Pharmaceuticals, Inc.]

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