Xarelto is a blood thinning medication with the active ingredient rivaroxaban, approved by the U.S. Food and Drug Administration (FDA) on July 1, 2011. According to WebMD, its purpose is to help prevent blood clots in patients with atrial fibrillation (irregular heartbeat), or after hip or knee replacement surgery, and to treat and prevent deep vein thrombosis (blood clots in the deep veins of the legs or pelvic region) or pulmonary embolism (blood clots in the lungs). Unfortunately, this drug has a number of serious and potentially fatal side effects, which have resulted in numerous lawsuits filed by injured patients against the manufacturer.
Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, is the company that manufactures Xarelto. Since FDA approval, the drug has been marketed as a convenient alternative to warfarin, a blood-thinning medication that required patients to have their blood monitored on a regular basis. The Xarelto website, displaying photos of world-class athletes and celebrities, states, “With Xarelto®, you can say goodbye to warfarin’s blood monitoring routine.” However, the absence of blood monitoring with this drug could put some patients at serious risk.
Xarelto: Risk of Hemorrhage
Pharmaceutical companies have a responsibility to advise physicians and patients of the safest and most effective ways to use their products. Hemorrhage – profuse bleeding – is the most common severe side effect of Xarelto. A simple blood test, done as infrequently as once per year, could help identify patients with a higher risk of hemmorhage caused by this drug, yet the manufacture chooses to promote the product on the basis of its convenience, claiming the drug “has no regular blood monitoring.”
Xarelto has been linked to serious bleeding complications, including hemorrhaging, wound leakage, and gastrointestinal bleeding. In lawsuits against the manufacturer, injured plaintiffs allege that, unlike other anticoagulant medications, the blood-thinning effects of Xarelto cannot be reversed by vitamin K, and there is no way to stop the bleeding once it begins. Patients have suffered life-threatening gastro-intestinal and internal hemorrhaging, and some of these injuries may have been prevented with regular blood monitoring.
Profit vs. the Best Interests of the Patient
Johnson & Johnson Janssen Pharmaceuticals promotes Xarelto as a prescription anti-coagulant proven to reduce stroke risk for patients with arterial fibrillation, reduce the risk of blood clots after knee or hip replacement surgery, and treat and help prevent pulmonary embolism and deep vein thrombosis. The company states that Xarelto is different than other blood-thinning medications, because it reduces these risks with:
- No frequent adjustments of the dosage (one less thing the patient needs to worry about);
- No dietary restrictions (you can continue eating the foods you like); and
- No regular blood monitoring (the patient can spend the time doing enjoyable things instead).
This reputed ease of use of Xarelto gives the manufacturer a distinct marketing advantage over warfarin. According to an article on Fierce Pharma, Xarelto has the biggest share of the anti-coagulant drug market — $1.5 billion in 2014, with sales up 58% in the fourth quarter. This marketing advantage might be compromised if the manufacturer informed doctors and patients that regular, infrequent blood testing could greatly reduce the risks of serious side effects with this drug.
Study Reveals Misconduct in Clinical Trials of Xarelto
In addition to questionable marketing, a study published in the Journal of the American Medical Association (JAMA) reveals research misconduct in clinical trials of Xarelto identified by the FDA. The study found that 8 of 16 FDA site inspections for clinical trials of Xarelto were rated OAI – Official Action Indicated. FDA inspectors discovered evidence of serious transgressions, such as:
- Unauthorized unblinding
- Discarding of medical records
- Improprieties in randomization
The research misconduct was so severe and prevalent that FDA rejected the entire study – RECORD 4 (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism) – as unreliable. As noted in the study published in JAMA, these problems with the clinical trials of Xarelto were not mentioned in associated publications or in the article regarding the results of the study.
Xarelto Attorneys Protecting Your Rights
If you have suffered serious injury from Xarelto, our Xarelto attorneys at Farah & Farah can help. We are dedicated to representing people who have been harmed by dangerous drugs and devices. We believe that dangerous drug manufacturers should be held accountable for the harm their products cause.
We are currently investigating cases involving Xarelto. If you have been harmed by this drug, you may be entitled to recover damages for the losses you have suffered, including medical expenses, lost wages, pain and suffering, and emotional distress. Contact us at (800) 533-3555 for a comprehensive, confidential case consultation, free of charge.