What is Xarelto?
Xarelto (rivaroxaban) is an anticoagulant, or blood thinner, prescribed to reduce the risk of stroke and blood clots in certain patients. The medication works by blocking a blood clotting factor called Factor Xa. It does not require routine blood monitoring, unlike other anticoagulants such as warfarin. It was first approved by the U.S. Food and Drug Administration (FDA) July 1, 2011.
The medication is manufactured by Janssen Ortho, LLC, Gurabo, PR; Janssen Pharmaceuticals, Inc., Titusville, NJ; and licensed from Bayer HealthCare AG, Leverkusen, Germany. Johnson & Johnson owns the rights to Xarelto in the United States. Bayer sells the drug in Europe.
Why is it Prescribed?
Xarelto has been approved by the FDA to:
- Reduce the risk of stroke in some patients who have atrial fibrillation
- Reduce the risk of blood clots in the legs and lungs of patients who have had hip or knee replacement surgery
- Treat patients with pulmonary embolism (PE) (blood clot in the lungs)
- Reduce the chances that there will be a recurrence of DVT or PE after being treated for an acute venous thromboembolism for six months
Xarelto is given to treat and prevent deep vein thrombosis (DVT), which is a blood clot that forms usually deep in the leg. This type of clot can break away from where it is lodged in the leg and travel through the bloodstream to the lungs. Here it can cause a pulmonary embolism (a travelling blood clot that suddenly gets stuck in the lungs).
Once lodged in the lung, four primary dangers exist for the patient:
- Lung damage because the clot blocks oxygen flow to lung tissue
- Lower blood oxygen levels
- Organ damage elsewhere in the body because of lack of oxygen reaching the organ
- Death, if the clot is large
FDA Refuses New Indication Approval for Xarelto
The FDA, however, has refused to grant marketing approval to Xarelto for a new indication—reducing the risk of heart attack and other cardiovascular problems in patients with acute coronary artery disease. Patients with this condition have less blood flowing to the heart muscle because of narrowed blood vessels. This increases their risk of heart attack and other catastrophic problems. Johnson & Johnson released the information of the FDA's denial of approval of the drug for this indication March 5, 2013.
Increased Risk of Severe Bleeding
The reason that the FDA denied approval was a concern about the side effects of bleeding that have been linked to the medication. Studies have shown that patients who took Xarelto were three times more likely to suffer from internal bleeding compared to patients taking other anticoagulants. The March 5 denial of approval was the second time Xarelto faced rejection for the same indication.
Important Information You Should Know About Xarelto
You should tell any doctor who is treating you that you are taking Xarelto. Because the drug keeps blood from clotting normally, there is the risk of increased, sometimes fatal bleeding. Any patient with active or uncontrolled bleeding should not take Xarelto.
Before having surgery for any medical procedure, the patient may need to stop using the drug temporarily. It is especially important not to stop taking Xarelto without first talking to the doctor who prescribed it. If the drug is stopped suddenly, the patient's chances of a stroke increase.
The medication can cause a serious blood clot around the brain or spinal cord if the patient has
- A spinal tap or has had repeated spinal taps
- A genetic spinal defect
- A history of spinal surgery
- Been using other anticoagulants
Many other drugs, even some over-the-counter medications such as aspirin or non-steroidal anti-inflammatories that can thin the blood, can cause excess bleeding if taken at the same time as the patient is taking Xarelto. Even some herbs can increase the risk of bleeding if taken with Xarelto.
A history of the following disorders may increase the risk of bleeding:
- An inherited bleeding disorder or one that is the result of a disease
- Hemorrhagic stroke
- Uncontrolled high blood pressure
- Bleeding in the stomach or intestines
A patient taking Xarelto should not stop taking it suddenly because of a risk of blood clots or a stroke.
Serious Side Effect of Xarelto
Because Xarelto reduces the blood's ability to form clots, it increases the risks of bleeding. Some serious side effects for which you should immediately call your doctor are:
- Any bleeding that won't stop
- Easy bruising
- Unusual bleeding from the mouth, nose, vagina or rectum
- Wound bleeding
- Bleeding from needle injections
- Unusually heavy menstrual periods
- Headache, feeling dizzy, faint, weak, or like you might pass out
- Red or pink urine
- Black or bloody stools
- Coughing up blood
- Vomit that looks like coffee grounds
- Numbness, tingling, or muscle weakness, (particularly in the legs or feet)
- Paralysis in any part of the body
Xarelto Bleeding Lawsuits
Xarelto has quickly become one of the leading anticoagulant medications since it received FDA approval in 2011. This is mainly because it has far less limitations that warfarin. The concern, however, is that it can significantly increase a patient's risk for uncontrollable bleeding that can result in death.
Our attorneys are currently investigating Xarelto lawsuits on behalf of patients who have taken the medication and who have suffered intestinal bleeding, brain hemorrhaging and rectal bleeding. We are also available to review lawsuits on behalf of families whose loved ones have died from uncontrollable internal bleeding events.
To discuss your circumstances with an experienced Xarelto lawyer, please contact us today.