FDA Alerts
FDA Approves First Recombinant Coagulation Factor IX
The US Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older.
FDA Approves Kcentra
The US Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding.
FDA Approves Eliquis for Atrial Fibrillation Patients
The US Food and Drug Administration today approved the anti-clotting drug Eliquis ( apixaban ), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
FDA Drug Safety Communication: Important Change to Heparin Container Labels
The US Food and Drug Administration (FDA) is notifying healthcare professionals, caregivers, and patients about a change to the container and carton labels for heparin products, which are blood-thinning agents that prevent the formation of blood clots.
FDA expands use of Xarelto to treat, reduce recurrence of blood clots
The US Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.
FDA Approves Xarelto To Reduce Risk Of Blood Clots
On July 1, the U.S. Food and Drug Administration approved Xarelto ( rivaroxaban ) to reduce the risk of blood clots, deep vein thrombosis ( DVT ), and pulmonary embolism (PE) following knee or hip replacement surgery.