Xarelto (rivaroxaban) is a prescription drug anticoagulant, or blood thinner. The medication is produced by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson company), under license from Bayer HealthCare AG of Germany. Xarelto was approved by the Food and Drug Administration (FDA) to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
Xarelto is in a class of medications called factor Xa inhibitors. It works by decreasing the clotting ability of the blood. Like other newer blood thinners, it does not require regular monitoring of the blood.
The same thing that prevents blood clots may also lead to uncontrolled bleeding. If the bleeding happens near a major organ such as the lungs, brain or kidneys, the organ may be damaged. Uncontrolled internal bleeding can have a severe impact, including death.
Xarelto patients who have experienced severe complications and their families have begun suing the makers of the drug, saying they did not have enough warnings about the side effects. This is happening as sales of the drug continue to rise, with nearly 1.2 million units sold between October and December 2013.
If you or a loved one has suffered complications related to Xarelto, you could be entitled to compensation for the physical injuries and emotional suffering you have endured. Contact our South Carolina dangerous drug lawyers at Joye Law Firm to find out what legal options you may have.
Call Joye Law Firm now or use our online contact form. There is no fee for the consultation and claim review.
No Antidote for Bleeding While On Xarelto
While internal bleeding is a risk of any blood thinner, other drugs have emergency antidotes to reverse the effects if internal bleeding develops. There is no antidote for Xarelto, so if a patient on the drug experiences internal bleeding, doctors must find other ways to combat the problem while the drug is flushed from the patient’s system.
The FDA recommends you call your doctor right away if you notice any of these symptoms while on Xarelto:
- Unexpected bleeding or bleeding that lasts a long time, such as nose bleeds that occur often, unusual bleeding from the gums or heavier than normal menstrual bleeding.
- Bleeding that is severe or that you cannot control.
- Red, pink or brown urine.
- Bright red or black, tar-like stools (looks like tar).
- Coughing up blood or blood clots.
- Vomiting blood or your vomit looks like coffee grounds.
- Headaches, dizziness or weakness.
- Pain, swelling or new drainage at wound sites.
Both the FDA and the makers of Xarelto caution against stopping the drug without consulting a doctor because the risk of stroke increases.
FDA Declines to Widen Uses for Xarelto
Xarelto, released in 2011, started out as a medication to reduce the risk of blood clots for people who had knee or hip replacement surgery. The FDA eventually expanded uses of the drug to include treatment for deep vein thrombosis and pulmonary embolism.
In February 2014, the FDA rejected a bid to widen the prescribed use of Xarelto. For the third time, the FDA denied a request from the makers of the drug to market it as a medication to reduce the risk of heart attack, stroke or death in patients with acute coronary syndrome (ACS). The FDA also declined an application to market Xarelto as a drug that can reduce the risk of stent thrombosis for ACS patients, along with standard antiplatelet therapy.
These rejections came after an FDA advisory group voted nearly unanimously against approving the drug as a treatment for ACS, something that would have been financially lucrative for the company.
The FDA has also changed the safety warnings and other documentation for Xarelto several times.
Help for Xarelto Injuries
If you or someone you love has experienced severe bleeding, including a life-threatening bleeding event or cerebral hemorrhage while on Xarelto, you may be entitled to compensation. Our law firm would like to speak with you. We may be able to help.
At Joye Law Firm, we are dedicated to our clients and our community. If you’ve been seriously injured by a dangerous prescription drug, you can trust our South Carolina drug injury attorneys to treat you with respect and work to get you the compensation you deserve.
Call Joye Law Firm now or fill out a free online consultation form and talk to our South Carolina injury lawyers today. There is no charge for the claim review and consultation, and it comes with no obligations.
- FDA – MedWatch: Xarelto (Rivaroxaban) Tablets
- FDA – Medication Guide Xarelto® (zah-REL-toe)(rivaroxaban) tablets
- Drugs.com – Xarelto Sales Data
- Medscape – FDA Again Denies Rivaroxaban ACS Indication
- Johnson & Johnson – FDA Issues Complete Response Letters for Use of XARELTO® (rivaroxaban) to Reduce the Risk of Secondary Cardiovascular Events and Stent Thrombosis in Patients with Acute Coronary Syndrome
- PharmaTimes – FDA rejects Bayer/J&J’s Xarelto, again