Xarelto is a new oral medication that is supposed to prevent strokes and blood clots. Unfortunately, its manufacturer, Bayer HealthCare, is facing allegations of failing to warn about its risks — including Xarelto’s lack of an antidote and the significant increased risk of a blood clot from missing just one daily dose. Schmidt & Clark, LLP is evaluating possible Xarelto lawsuits involving serious bleeding, blood clots, and other side effects.
Free Xarelto Lawsuit Evaluation: If you or your loved one is a resident of the USA and was injured by Xarelto, contact our law firm immediately for a free case consultation. If you file a lawsuit, you could receive compensation for your injury, medical expenses, and more.
What is Xarelto?
In 2011, the U.S. Food and Drug Administration (FDA) approved Xarelto (generic: rivaroxaban) for the prevention of blood clots and stroke. Approved indications include patients who have had hip or knee surgery and patients who have a type of irregular heart rhythm known as atrial fibrillation.Missing a Dose of Xarelto
Xarelto is a once-daily pill. Missing a dose of Xarelto is very serious because it patients rapidly lose protection against blood clots. Due to this risk, the FDA has required a “Black Box” warning about the increased risk of blood clots from prematurely discontinuing Xarelto.
There is a much lower margin of safety for Xarelto patients who skip a dose compared to warfarin patients. Warfarin takes 24 hours to start working, but each dose protects against blood clots for 2-5 days.
Normally, Xarelto prevents blood clots by blocking an enzyme called factor Xa, a key link in a chain of events that causes a blood clot to form. It starts working 2-4 hours after a dose, is active in the body for 8-12 hours, and prevents factor Xa levels for 24 hours.
Xarelto Has No Antidote
Coumadin (warfarin) is a rat pesticide and blood-thinner that was approved in 1956. It’s advantages as a blood-thinner were discovered after doctors treated a man who ingested rat poison and started bleeding. He survived after doctors gave him Vitamin K, a reversal agent for warfarin that allows blood clots to form and stop bleeding.
Xarelto has no reversal agent. This could be a big problem after a traumatic accident or before an unplanned surgery. If doctors cannot de-activate Xarelto, patients are at risk of death from uncontrollable bleeding. Other new blood-thinners, such as Pradaxa (dabigatran), can be de-activated with several hours of dialysis. Unfortunately, Xarelto binds too tightly to plasma proteins to make dialysis an effective reversal agent. Other common pro-coagulation reversal agents were never explored in clinical trials of Xarelto.
Xarelto and Blood Clots
Xarelto is supposed to prevent blood clots. If it fails, patients are at risk of developing many life-threatening side effects. In the first three months of 2012, Xarelto was linked to 150 adverse event reports involving blood clots. The Institute for Safe Medicine Practices (ISMP) published a QuarterWatch report to warn that some patients may have an increased risk:“The largest identifiable category was serious blood-clot-related injury — most frequently pulmonary embolism — the very events rivaroxaban is intended to prevent. … These thromboembolic events with rivaroxaban occurred in younger patients (median age 66 years) taking the anticoagulant drugs after hip or knee replacement surgery.”
- Blood clots
- Venous thrombosis
- Pulmonary embolism
- Deep Vein Thrombosis (DVT)
- Circulatory problems
- Heart attack
- Severe bleeding