The blood thinner drug sold under the name Xarelto (Rivaroxiban) has been criticized by reviewers from the U.S. Food and Drug Administration (FDA) for what they’re calling a lack of efficacy in preventing stroke in certain patients.
Physicians prescribe Xarelto for stroke prevention in people with non-valvular atrial fibrillation or “AF”.
This conclusion was the result of a meeting of the FDA Cardiovascular and Renal Drugs Advisory Committee, a group that reviews prescription drugs and makes recommendations as to whether a particular medication should be approved for a specific indication or ailment.
Xarelto is a new generation anti-coagulant drug that’s known as an Xa inhibitor. The blood thinner medication inhibits a substance known as thrombin, which is, in part, responsible for the formation of blood clots. These blood clots can then travel to the lungs or brain, causing a deadly event such as a stroke or pulmonary embolism. Physicians prescribe Xarelto for stroke in patients who are at high risk of this potentially deadly condition.
FDA on Xarelto for Stroke Prevention in Atrial Fibrillation Patients
A number of FDA reviewers came down on Xarelto’s efficacy in preventing stroke in patients suffering from an irregular heartbeat condition known as non-valvular atrial fibrillation (AF). These individuals are at a much higher risk of experiencing a stroke or pulmonary embolism.
Blood thinners are typically prescribed to lower the patient’s stroke risk, but some have criticized Xarelto for its high risk of complications. Xarelto complications can include uncontrolled bleeding and even blood clots and stroke — the very conditions that the blood thinner is intended to prevent.
Drug manufacturer Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, even sponsored a study which has come to be known as the “Rocket-AF study.” This study involved over 14,000 patients who were diagnosed with non-valvular atrial fibrillation. Some were prescribed 20 mg of Xarelto daily, while others were prescribed Warfarin/Coumadin to lower the patients’ stroke risk.
The Rocket-AF study’s results suggested that when prescribing Xarelto for stroke patients, the drug was equally effective when compared to Warfarin/Coumadin – the traditional treatment for preventing stroke in patients with AF. The study results claimed that Xarelto was much easier for the patient, since it does not require the intensive blood monitoring and dietary change that is required while using Warfarin/Coumadin. The study results also claimed that the two drugs had a comparable major bleeding risk (a claim which has since been contradicted by newer studies which have found that Xarelto actually has a higher major bleeding risk than Warfarin/Coumadin.)
The FDA reviewers also criticized the study results for some glaring omissions, such as the fact that there is no antidote or reversal agent available for Xarelto. This makes major Xarelto bleeding incidents significantly more dangerous.
What’s more, the study ended 2 days after the patient’s last dosage. The study did not include data on the transitionary period whereby patients were transitioned from Xarelto to Warfarin/Coumadin — a notoriously risky process. In fact, one FDA reviewer indicated that Xarelto would need to perform a study focusing on the transitioning process.
Initially, it was claimed that Xarelto was superior to Warfarin/Coumadin for preventing strokes in patients with AF. But it was revealed that the cases where Xarelto appeared to be superior were “misleading” as improper Warfarin/Coumadin dosing may have skewed the results.
Ultimately, it was found that Xarelto was not superior but equal to Warfarin/Coumadin in terms of its efficacy. But once other factors were considered – such as the lack of antidote and potential study flaws – at least one FDA reviewer called Rivaroxiban inferior to Warfarin/Coumadin.
Notably, in order to receive FDA approval for the treatment of a specific condition or indication, a drug must prove that it is at least equally effective when compared to the existing drugs that are currently available on the market.
Xarelto did ultimately receive FDA approval for use in the prevention of stroke in patients with non- valvular atrial fibrillation. It’s also prescribed for reducing the risk of pulmonary embolism, deep-vein thrombosis and preventing deep-vein thrombosis in patients undergoing knee replacement or hip replacement procedures. But the drug remains quite controversial.
Uncontrolled Internal Bleeding and Xarelto
When it comes to Xarelto, strokes, uncontrolled bleeding and other serious complications have been reported. Major bleeding incidents may include stomach and other GI bleeds, colon bleeding, eye bleeding, brain bleeds and kidney (renal) bleeding.
A number of Xarelto studies have been performed. Some have revealed a 200% higher risk of bleeding when compared to Warfarin/Coumadin. And as mentioned above, there is no Xarelto antidote or reversal agent available.
Many patients and family members of deceased patients have filed Xarelto lawsuits on the basis that they were never informed of the drug’s risks and complications. Some have also criticized the drug makers, calling them irresponsible for releasing a medication that does not have an antidote or reversal agent available.
Legal Action for Xarelto Patients
Xarelto lawsuits now number in the hundreds, with over 1230 cases filed as of August 2015.
The sheer volume of Xarelto lawsuits has prompted the formation of a multi-district litigation (MDL) case. This is designed to simplify and accelerate pre-trial processes like discovery and evidence sharing for similar cases.
These 1200+ Xarelto MDL lawsuits are now in the Eastern District of Louisiana under the guidance of Judge Eldon Fallon. Bellwether trials are slated to begin in August 2016.
If you or a family member experienced major bleeding incident, or experienced a stroke while on Xarelto, you may have a right to receive financial compensation.
Contact the experienced and compassionate legal team here at The Meldofsky Firm. Call us today for a free, private case evaluation. Call (877) 274-8672.