Widespread reports of injury continue to emerge from patients who have taken the blood-thinning drug Xarelto. The anticoagulant — which has seen blockbuster success since its introduction in 2012 — is linked to fatal bleeding events to which there is no antidote.
Xarelto (rivaroxaban) is approved by the United States Food and Drug Administration to reduce the risk of stroke and blood clots in persons with atrial fibrillation (AFib) not caused by a heart valve problem. Atrial fibrillation is an irregular, often rapid, heartbeat that typically results in heart palpitations, weakness, and shortness of breath. Xarelto is also prescribed to treat and reduce the risk of deep vein thrombosis and pulmonary embolism. Finally, the drug is prescribed to patients to reduce the risk of blood clots in the legs and lungs to patients following knee or hip replacement surgery. In the U.S., it is marketed by Janssen Pharmaceutical, a Johnson & Johnson subsidiary, and was jointly developed, and is marketed and distributed by Janssen, Johnson & Johnson, and Bayer.
Janssen, Johnson & Johnson, and Bayer launched an aggressive marketing campaign beginning in 2012 upon Xarelto’s approval by the FDA. The campaign worked. The company reported that approximately 130,000 prescriptions were written for Xarelto in the first three months of 2012 in the U.S. alone. In its June 2013 World Preview Report, EvaluatePharma wrote that it expected Xarelto to be the 19th best-selling drug in the world by 2018 and for worldwide sales to rise from $596 million in 2012 to $3.7 billion in 2018.
Xarelto costs about $3,000 per year, versus $200 for generic warfarin—the standard drug used for the same purpose in AFib patients for decades prior to the introduction of Xarelto to the market. Unlike Xarelto, warfarin has an antidote in the case of bleeding.
The Xarelto marketing campaign touted that the benefit of using Xarelto over warfarin was the lack of the need for blood monitoring. For the bulk of the marketing campaign, the company claimed on its website and in marketing materials that, “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.”
In June of 2013, the FDA’s Office of Prescription Drug Promotion sent to Johnson & Johnson International a warning letter regarding a Xarelto print advertisement that ran earlier that year in WebMD magazine, stating that their print advertisement was “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim” regarding blood monitoring and that “no dosage adjustments” were required. Only after receiving the FDA warning letter, and amidst growing complaints and news reports about the risk of uncontrollable bleeds, were the words “without routine blood monitoring” removed from the Xarelto website.
“Black box warnings” are the strongest medication-related safety warnings in a drug’s labeling information and highlight major risks of serious or life-threatening effects. Despite a label change in March 2014—and after widespread complaints, the FDA warning letter, and growing cries in the media—Xarelto’s label remains to this day without a “black box” warning alerting patients and prescribing doctors about the possibility of irreversible bleeds.
What Does this Mean for You?
If you have experienced a bleeding event while using the drug Xarelto, you may be legally entitled to compensation for medical costs, loss of income, and other damages.
Want to Know if You Have a Valid Legal Claim?
Kelley Law Firm, PC attorneys are investigating the safety risks of Xarelto and monitoring all developments. If you or a loved one took Xarelto and suffered internal bleeding or a related medical condition, please contact us by submitting the form, or by calling us at 1-800-498-Kelley for a confidential evaluation of your potential claim.