The powerful blood-thinner drug Xarelto has been linked to excessive bleeding among those who use it to prevent blood clots. If you or someone you love has been hospitalized because of internal bleeding after taking Xarelto, get help from our pharmaceutical liability lawyers now.
Xarelto is an anticoagulant prescribed to treat deep vein thrombosis (a blood clot in the legs) and pulmonary embolism (a blood clot in the lungs). Doctors also prescribe the drug to patients who have recently had knee or hip replacement surgery. Xarelto, a Bayer HealthCare product, is meant to replace warfarin, a blood thinner used for more than 50 years. However, unlike warfarin, no antidote currently exists for rivaroxaban, the active ingredient in Xarelto.
Many patients have complained of severe internal bleeding after using Xarelto, and the Food and Drug Administration (FDA) has since issued several warnings, including its most severe label warning about the danger Xarelto presents for spinal bleeds, which are known as epidural or spinal hematomas.
If you or a loved one has been injured by use of Xarelto, you may have the right to seek compensation for your losses in a Xarelto lawsuit. The lawyers of Morris, King & Hodge, P.C., are dedicated to holding the makers of unsafe medical products responsible for the harm they cause, including any failure to warn patients and physicians of the increased risk of irreversible and potentially fatal internal bleeding Xarelto might cause. To learn more, contact our Huntsville Alabama Injury attorneys today for a free review of your case.
Table of Contents
The Potential Dangers of Xarelto Use
Xarelto blocks specific proteins that help the blood to clot. Doctors may prescribe the drug to people with atrial fibrillation (irregular heart beat) who are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body.
In 2011, the FDA approved the use of Xarelto to treat deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment. A DVT is a blood clot in an extremity, usually the lower leg. A PE is a blood clot in the lung, which can be deadly. Blood clots that break free can cause a stroke if they travel to the brain, or heart attack if they travel to the heart.
But because a Xarelto user’s blood does not clot, they can suffer from excessive bleeding, or hemorrhaging. This includes internal bleeding, as well as bleeding from a wound should they suffer a traumatic injury in an accident.
No antidote exists for rivaroxaban, and no known way exists to immediately stop bleeding in a Xarelto patient. For example, doctors can administer a vitamin K antidote to stop bleeding in a patient who takes the anti-coagulant warfarin (sold as Coumadin and Jantoven).
According to the FDA, Xarelto use can lead to several types of hemorrhaging, including:
- Bleeding in the brain
- Intestinal or abdominal bleeds
- Bleeding from the rectum
Other severe health conditions associated with the use of Xarelto include:
- Cerebrovascular accidents (i.e., an event that leads to a stroke, such as a cerebral hemorrhage)
- Decreased hemoglobin (a substance that carries oxygen in red blood cells)
- Hematoma (a semi-solid mass in the blood)
- Peripheral edema (swelling of the lower limbs)
- Dyspnea (difficulty breathing)
FDA Warnings About Xarelto Use
The FDA has directed Xarelto’s makers, Bayer HealthCare’s Janssen Pharmaceuticals unit, to add warnings to the drug’s packaging. They include notifications to physicians that:
- Premature discontinuation of Xarelto increases the risk of thrombotic events (blood clots in the circulatory system, like DVT or PE), and spinal/epidural hematoma (blood clots in tissue). This was to be a boxed warning on the drug’s packaging.
- There is no antidote to the free-bleeding effect of Xarelto, and physicians should promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement (transfusion) among Xarelto users.
- Medical professionals do not know the appropriate time a patient should wait between use of Xarelto and undergoing an epidural or spinal anesthesia/analgesia, or spinal puncture procedure. The warning advises doctors who treat Xarelto users with these procedures to monitor their patients frequently to detect any signs or symptoms of neurological impairment.
But despite these known risks, the FDA continues to say Xarelto is more effective than warfarin, and that its positive effects justify the risk of its use.
Assessing Your Xarelto Legal Rights
If you or a family member has been injured by a case of severe, uncontrollable bleeding after taking Xarelto (rivaroxaban) as prescribed, you may be eligible to obtain compensation for your medical expenses, pain and suffering, and other losses. The AV-rated firm of Morris, King & Hodge, P.C., is dedicated to helping patients who have been harmed by faulty pharmaceuticals (drugs). Our track record of success includes obtaining over $30 million in settlements for deserving clients.
To discuss your legal options with a firm partner free of charge, call us at (256) 677-4376 or (888) 445-5585, or send us a message online.
- Food and Drug Administration – Xarelto Medication Guide