million patients had been treated. Legal status In September 2008, Health Canada granted marketing authorization for rivaroxaban to prevent venous thromboembolism (VTE) in people who have undergone elective total hip replacement or total knee replacement surgery. In the same month, the European Commission also granted marketing authorization of rivaroxaban to prevent venous thromboembolism in adults undergoing elective hip and knee replacement. On July 1, 2011, the US Food and Drug Administration (FDA) approved rivaroxaban for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery. On November 4, 2011, the US FDA approved rivaroxaban for stroke prevention in people with non-valvular atrial fibrillation. Legal action On March 25, 2019, over 25,000 lawsuits over rivaroxaban in the US were settled for $775 million to get paid out to those affected. Plaintiffs accused the drugmakers of not warning about the bleeding risks, claiming their injuries could have been prevented had doctors and patients been provided adequate information. Research Researchers at the Duke Clinical Research Institute have been accused of withholding clinical data used to evaluate rivaroxaban. Duke tested rivaroxaban in a clinical trial known as the ROCKET AF trial. The clinical trial, published 2011 in the New England Journal of Medicine and headed by Robert Califf, then Commissioner of the FDA, found rivaroxaban to be more effective than warfarin in reducing the likelihood of ischemic strokes in patients with atrial fibrillation. The validity of the study was called into question in 2014, when pharmaceutical sponsors Bayer and Johnson & Johnson revealed that the INRatio blood monitoring devices used were not functioning properly, A subsequent analysis by the Duke team published in February 2016 found that this had no significant effect on efficacy and safety in the trial. Under-representation of racial minorities in clinical trials has been noted. Compared to warfarin, efficacy and safety was found to be similar across racial subgroups. References External links Wikipedia medicine articles ready to translate Direct Xa inhibitors Morpholines Thiophenes Chloroarenes 3-(4-methoxyphenyl)-2-oxazolidinones Johnson & Johnson brands Janssen Pharmaceutica Bayer brands