Xarelto can cause serious bleeding because of how it affects blood clotting proteins. Notify your doctor immediately if you notice any of the following signs of serious bleeding while taking Xarelto:
- Unusual pain, swelling or discomfort
- Unusual bruising
- Prolonged bleeding from cuts or gums
- Persistent and/or frequent nose bleeds
- Unusually heavy or prolonged menstrual flow
- Coughing up blood
- Dark urine and/or tarry stools
- Vomit that is blood or looks like coffee grounds
- Severe headache, dizziness or fainting
- Unusual or persistent tiredness and fatigue
- Difficulty swallowing
Simmons Hanly Conroy lawyers are currently investigating serious bleeding incidents in the brain and gastrointestinal track linked to the use of Xarelto, an alternative oral anticoagulant drug prescribed to prevent blood clots.
Xarelto bleeding lawsuits are now being filed against Bayer and Jassen Pharmaceuticals as a result of serious uncontrollable bleeding incidents experienced by patients who took the alternative oral anticoagulant drug to prevent blood clots. Unlike Warfin, the traditional blood thinning drug, there is no current reversal agent for Xarelto, making it a particularly dangerous drug.
What is Xarelto?
Xarelto is a blood thinner taken once daily to prevent the formation of blood clots. Because the drug is designed to stop the blood from clotting, there is a possibility that any injury – even a minor one – can be very dangerous.
Xarelto was approved by the U.S. Food & Drug in 2011 to treat the following:
- Reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem.
- Treat deep vein thrombosis and pulmonary embolism.
- Reduce the risk of forming a blood clot in the legs and lungs of adults recovering from knee or hip surgery.
Xarelto was invented and manufactured by Bayer before 2008. In the United States, it is marketed by Jassen Pharmaceuticals, a division of Johnson & Johnson, as an alternative to Warfin because Xarelto does not require blood monitoring. However, many users have found that the convenience of Xarelto does not warrant its risk of serious side effects.
Xarelto Drug Safety Alerts
The Institute for Safe Medication Practices (ISMP), an independent health nonprofit group that monitors FDA MedWatch Reports, has called anticoagulant drugs, like Xarelto and Pradaxa, “a high-risk treatment that causes bleeding in approximately 15 percent of patients with atrial fibrillation exposed for a year.”
In 2012, the FDA received hundreds of reports of adverse effects in Xarelto users. Then another 638 adverse reports linked to Xarelto use were submitted to the FDA in early 2013. ISMP cited the increase to more prescriptions of Xarelto being dispensed. In 2014, Xarelto was the anticoagulant most commonly prescribed and reported to the FDA for severe adverse effects, surpassing Pradaxa by a significant amount.
Many of the adverse effects noted in the reports were related to dangerous internal bleeding. In fact, Xarelto has been linked to an increased risk of uncontrollable bleeding. The potentially fatal bleeding is a result of how the drug affects blood clotting in the proteins – a commonality among most anticoagulant (blood thinning) medications. However, Xarelto stands apart from other blood thinners because there is no reversal method once the internal bleeding has begun.
Because of Xarelto’s increased risk of uncontrollable bleeding, the FDA rejected a bid from Bayer and J&J to approve the drug for use in prevention of new heart attacks and strokes in patients with acute coronary syndrome. According to Reuters, FDA panel members said the benefit of the drug was not shown to outweigh an increased risk of bleeding.