In 2013, Xarelto’s Manufacturer Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) received a warning letter from the FDA regarding a print advertisement for Xarelto. The advertisement was included in WebMD magazine and boasted such claims as, “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.”
If this statement sounds familiar, that’s because it was repeatedly used by Janssen in additional print and television advertisements despite the FDA warning. Statements like this were specifically described by the FDA as “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.” Janssen never responded to the FDA’s letter nor did they alter their message in advertisements.
Like any anticoagulant medication, Xarelto comes with an increased risk of excessive or uncontrollable bleeding. While some anticoagulants like Warfarin have antidotes, there is no consistent way to reverse the effects of Xarelto in the case of excessive bleeding.
This has lead to thousands of adverse bleeding events in patients who allege the company minimized the risks. Over 5,000 lawsuits are pending against the company and plaintiffs are pointing to the FDA’s 2013 warning letter as an example of Janssen’s failure to warn consumers about the risks involved with taking the medication.
However, Janssen’s failure to warn isn’t the only problem with Xarelto. The clinical trial data that lead to the drug’s approval is under scrutiny after it was discovered that the drug trial used a blood-monitoring device that was recalled for inaccurate readings. Plaintiffs in the Xarelto lawsuits are alleging that the drug should have never been approved because the clinical trial data didn’t properly measure effectiveness.
If this wasn’t enough, a recent study found that Xarelto was no better than other types of anticoagulants, making some patients and doctors conclude that the risks of Xarelto far outweigh the benefit.
While the evidence against the safety of Xarelto is lining up, plaintiff’s eagerly await their day in court. Bellwether trials have been selected by the plaintiff’s lawyers and the defense and will begin in early 2017.