Since approval, the FDA has received postmarketing safety data on thromboembolic events, including serious and fatal outcomes, in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). Based on available data, the serious risks including the increase in thromboembolic

http://www.fda.gov/safety/medical-product-safety-information/update-safety-andexxa-astrazeneca-fda-safety-communication