Since the drug Xarelto (Rivaroxaban) was approved by the U.S. Food and Drug Administration to treat atrial fibrillation, a condition that causes blood to pool in the storage chamber of the heart where it can clot and travel to the brain, there have been over 2,100 reports made to the FDA regarding adverse side effects involving the drug, with over 1,800 listing Xarelto as the primary culprit.
What is Xarelto?
Xarelto is an anticoagulant drug that was first approved by the FDA in 2011. It is co-marketed by Bayer and Johnson and Johnson, and belongs to a class of anticoagulants, or blood thinners, called direct factor Xa inhibitors. Xarelto has three main uses:
- To reduce the risk of blot clots and stroke in patients with atrial fibrillation
- To treat deep vein thrombosis and pulmonary embolism
- To reduce the risk of blood clots in patients undergoing knee or hip replacement surgery
About 130,000 U.S. prescriptions were written for Xarelto in the first three months of 2012, despite concerns that the drug does not have a known antidote for a bleeding emergency and not all patients taking it have undergone testing ahead of time to ensure good kidney function.
Side Effects of Xarelto
Despite its uses, Xarelto has been linked to some serious and life-threatening side effects, including:
- Uncontrolled bleeding events
- Pulmonary embolism
- Deep vein thrombosis
- Gastrointestinal hemorrhage
- Hemoglobin decrease
- Cerebrovascular accidents
- Edema peripheral
Concerns About Xarelto
Physicians have also expressed concern that the use of Xarelto, which does not require regular blood monitoring or frequent doctor follow-up, might raise the risk of serious and uncontrolled bleeding events, stroke, and blood clots, particularly in patients who suffer from poor kidney function.
Early in 2014, an FDA panel rejected wider use of Xarelto, voting for the third time against recommending approval of the drug for use in the 90 days after an acute coronary syndrome (ACS). The panel remained unconvinced that the risk-benefit balance for the drug was favorable in the 90 days after an ACS.
If you have suffered uncontrollable bleeding or if your loved one lost life due to bleeding after taking Xarelto we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced drug injury lawyers will work closely with you and fight for the maximum compensation for your injuries.