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No recall has yet been issued for the drug; however, Xarelto lawsuits have been filed across the nation. The Xarelto attorneys at Barrios Kingsdorf & Casteix, L.L.P., are currently reviewing potential lawsuits related to its use. If you’ve suffered serious injuries as a result of this blood-thinning medication, contact our New Orleans-based law firm today to schedule a free consultation and find out what your legal rights are.
Xarelto is a prescription anticoagulant, referred to more commonly as a blood thinner. The drug is manufactured by Janssen Pharmaceuticals and was approved by the U.S. Food and Drug Administration, or FDA, in 2011.
It belongs to a class of blood thinners known as direct factor Xa inhibitors, which work by interfering with the body’s natural clotting function.
Blood clotting is essential process to stop bleeding from a wound, but people with certain medical conditions experience clotting when they should not. Also known as a rivaroxaban, Xarelto is widely prescribed to treat patients with such conditions, which includes atrial fibrillation, deep vein thrombosis, pulmonary embolism and stroke.
Atrial fibrillation is marked by an irregular heartbeat and can cause blood to collect in the heart and lead to blood clots that can travel to the brain and lead to a stroke.
Deep vein thrombosis refers to blood clots that develop in the legs, and pulmonary embolism refers to blood clots in the lungs. Both conditions can lead to serious health complications and even death if not treated.
Xarelto is also sometimes used in patients who have undergone knee or hip replacement surgery.
Unfortunately, in too many cases Xarelto side effects have been found to outweigh the benefits of this drug.
When you experience a side effect from a prescription or over-the-counter drug, it’s known as an adverse event. You or your doctor can report this adverse event to the FDA. The FDA records this data in the Adverse Events Reporting System.
A special software developed by a company called Adverse Events Inc. analyzes this data to compile detailed side effect information reported by U.S. patients.
Less than a year after its approval and introduction into the marketplace, a report from the Institute for Safe Medication practices notes that at least 350 “serious, disabling or fatal” Xarelto side effects were reported to the FDA. Many more have been reported in the years since.
In this report, one of the most common problems noted was one of the critical conditions that Xarelto is used to treat and prevent — pulmonary embolism. This side effect of Xarelto use was most commonly found during short-term use after a surgery.
Yet another of the most serious side effects has been Xarelto internal bleeding. All anticoagulants on the market carry a risk of bleeding-related side effects, including warfarin. Warfarin was the most-prescribed anticoagulant on the market since the 1950s and bleeding related to its use is able to be reversed through a combination of vitamin K and plasma.
Xarelto, on the other hand, has no approved reversal agent to stop bleeding once it begins. That means once you start bleeding, doctors may be unable to make it stop before serious injury or death occurs. While doctors have reported some success in using prothrombin complex concentrates for Xarelto bleeding events, this is not yet an FDA-approved method.
Other critical side effects of Xarelto use include:
When a blood vessel is damaged, for example when you receive a cut, the blood will coagulate or become thicker, forming a clot at the site of the injury to prevent excessive bleeding. For most people, a blood clot is a normal healthy body’s reaction to such an injury.
For some people, though, their blood clots in ways that it shouldn’t, which can lead to serious injuries and death. The purpose of Xarelto use is to prevent these blood clots from forming when and where they should not.
It works by thinning the blood so it does not clot improperly, and it does this by blocking proteins in the blood that start the clotting process. If you are injured while on this medication, the drug will prevent your blood from doing what is natural — clotting at the site of the injury — leading to dangerous Xarelto-related bleeding events.
It takes up to 24 hours for the medication to be flushed from the patient’s system. For older adults, it can be more difficult to flush the drug out, and the blood thinning effects may last longer, putting senior citizens at a higher risk for potentially fatal Xarelto bleeding.
Patients who are schedule for surgery must stop using the medication at least 24 hours before the procedure. Also, women who take Xarelto and are pregnant may be at risk for hemorrhaging.
Blood thinners are not a new medical concept. Warfarin (brand name Coumadin) has been in use since 1954. However, warfarin requires regular blood monitoring, dietary restrictions and frequent dosage adjustments.
In contract, Janssen Pharmaceuticals marketed Xarelto as a more convenient option, requiring no blood monitoring or dietary adjustments. At least one study has suggested, though, that regular blood monitoring could pinpoint which patients are at risk for Xarelto bleeding, potentially preventing this serious side effect.
Japanese researchers used rivaroxaban (the generic name for Xarelto) to treat 136 patients with a mean age of 75 years old who were suffering from non-valvular atrial fibrillation. The study included performing blood tests to monitor blood clotting at the start of the study and two weeks after beginning the drug.
In some patients, a prolonged blood thinning effect was found. The study concluded that continuing the regular blood monitoring could indicate which patients might be at a higher risk of serious bleeding related to the drug because of this prolonged thinning effect.
In a warning letter to Janssen Pharmaceuticals, the FDA noted that the drug’s promotional materials stated “Xarelto is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce the risk of stroke—without routine blood monitoring.”
The FDA letter warns that the “overall presentation misleadingly minimizes the risks associated with Xarelto” and “fails to convey this important risk information.”
No recall has yet been issued for the drug; however, Xarelto lawsuits have been filed across the nation. The Xarelto attorneys at Barrios Kingsdorf & Casteix, L.L.P., are currently reviewing potential lawsuits related to its use.
If you’ve suffered serious injuries as a result of this blood-thinning medication, contact our New Orleans-based law firm today to schedule a free consultation and find out what your legal rights are.