Latest research on Xarelto

Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food. FDA approved on July 1, 2011.

Latest findings

The FDA-Clinical Pharmacology Biopharmaceutics Review(s) of Xarelto also mentions that a two-fold increase in exposure due to intrinsic and extrinsic factors will increase the risk of major bleeding by 50% [17]. [source, 2015]
Rivaroxaban (Xarelto), an oral oxazolidinone-based anticoagulant, is a potent direct factor Xa inhibitor. [source, 2015]
The trade name of rivaroxaban is Xarelto (Bayer HealthCare, Leverkusen, Germany). [source, 2015]
In 4 of the 5 patients Coumadin was used in long term with the INR targeted between 2 and 3 and one patient was given Pradaxa 150 mg twice per day after 90 days of enoxaparin, while in 1 patient, Coumadin was later supplanted by Xarelto, 20 mg/day. [source, 2015]
In one patient (number 1), after 3 years on Coumadin, therapy was switched to Xarelto, 20 mg/day. [source, 2015]
Recently, the results of the large, phase IV XAMOS study (Xarelto in the prophylaxis of post-surgical venous thromboembolism after elective Major Orthopaedic Surgery of hip or knee) and the ORTHO-TEP (large single-center) registry have been published. [source, 2015]
When anticoagulation therapy had to be concurrently used, oral vitamin K2 therapy was ceased before use of Warfarin and dropped out from study; sometimes rivaroxaban (Xarelto, Bayer) was used to continue vitamin K therapy. [source, 2015]
According to the website Institute for Safe Medication Practices [7], warfarin (Coumadin) and newcomers Dabigatran (Pradaxa) and rivaroxaban (Xarelto) counted for 1734 reports to the FDA in the 2nd quarter of 2012, including 233 patient deaths, reinforcing the conclusion that anticoagulants rank among the highest risk of all outpatient drug treatments. [source, 2015]
The German newspaper Der Speigel stated that at least 968 adverse events involving Xarelto were reported to German health officials in the first eight months of 2013, including 72 deaths. [source, 2015]
The numbers compare to 750 adverse events and 58 deaths throughout all of the previous year, indicating that the increase tracked with the rise in use of Xarelto, which had reportedly increased 240% after just 1 1/2 years on the market. [source, 2015]