Bayer HealthCare Pharmaceuticals Inc. has informed US FDA that it will begin removing the remaining Trasylol stock from the US market. The US FDA will work with Bayer to ensure a smooth and complete process.
Trasylol is an antifibrinolytic drug approved to reduce blood loss during surgery and the need for blood transfusion in certain patient undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. Antifibrinolyitc drugs help slow the breakdown of blood clots and subsequent excessive bleeding.
Earlier on November 5, 2007, the US Food and Drug Administration asked Bayer Pharmaceuticals Corp. withdraw Trasylol as preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.
Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.