New Oral Anti-coagulant - EXANTA

During the morning ward round with Dato' Kxxxx, we encountered a patient who developed Deep Vein Thrombosis (DVT) due to prolonged immobolization after an abdominal surgery. Dato' asked the final year medical student who was taking care of this patient if he knew about any alternative oral anti-coagulant to Warfarin. It (EXANTA) was rather a very new research into replacing the conventional prophylaxis for venous thromboembolism (VTE) diseases. [Exanta is marketed for up to 11 day use in prevention of venous thromboembolic events (VTE) in patients undergoing elective hip or knee replacement surgery.] Warfarin has been closely associated with bleeding as a major adverse effect, thus requiring close monitoring of INR. However, EXANTA is not without its side effects, though the preliminary research results showed more superior treatment outcomes than Warfarin. Its major concern is derranged liver enzymes and hepatotoxicity. The withdrawal of Exanta has been triggered by this new patient safety data in the EXTEND clinical trial. The trial was then discontinued and Exanta-treated patients switched to other treatments.estimates that approximately 400 patients are presently being prescribed the drug for short-term prevention of VTE following orthopaedic surgery. Therefore, in the interests of patient safety, is taking the precautionary measure of withdrawing Exanta. it has informed regulatory authorities of its decision to withdraw Exanta and is now communicating with all prescribers and healthcare professionals to advise them that no new patients should be started on Exanta.
Malaysia is not facing such problem as we did not approve nor market the drug into the counrty. [Countries where Exanta is marketed are Germany, Portugal, Sweden, Finland, Norway, Iceland, Austria, Denmark, France, Switzerland, Argentina and Brazil.· Countries where Exanta is approved but not marketed are Belgium, Spain, The Netherlands, Luxembourg, Greece, Indonesia, Hong Kong, Italy, Russia and Ukraine.]
For patients currently taking Exanta, doctors should consider changing treatment to an alternative anticoagulant while taking account of individual patient circumstances and ensuring uninterrupted anticoagulation. The small number of current Exanta patients should be contacted by their doctor and reviewed promptly to avoid any unplanned discontinuation of therapy. will maintain the supply of Exanta for a short period to allow doctors to manage patients during this transition.
The company remains committed to the discovery and development of new medicines in this area to help improve patients' lives, for thrombosis is still one of the greatest threats to human health and represents a significant public health burden.
* EXANTA is also known as Exarta™ in Italy and Sweden*