Arterial and Venous Thromboembolic Complications

• Patients being treated with Vitamin K antagonists (VKA) therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the potential risks of thromboembolic events (TE), especially in patients with the history of a thromboembolic event. Resumption of anticoagulation should be carefully considered as soon as the risk of thromboembolic events outweighs the risk of acute bleeding.
• Both fatal and non-fatal arterial and venous thromboembolic complications have been reported with Prothrombin Complex Concentrate (Human) in clinical trials and post marketing surveillance. Monitor patients receiving Prothrombin Complex Concentrate (Human) for signs and symptoms of thromboembolic events. 
• Prothrombin Complex Concentrate (Human) was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months.  Prothrombin Complex Concentrate (Human) may not be suitable in patients with thromboembolic events in the prior 3 months.