Bayer pulls remaining stocks of Trasylol

Bayer Pharmaceuticals Corp, a division of the German drugmaker, has agreed to a US Food and Drug Administration-requested marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery. Previously, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding and at that time Bayer elected to temporarily suspend marketing of the product (Marketletter November 12, 2007).

Now, Bayer has notified the FDA that it will begin removing the remaining Trasylol stock from the US market, most of which is in warehouses and hospitalsss or physician's stocks. The agency will work with the company to ensure a smooth and complete process.

Under a limited use agreement, access to Trasylol is restricted to investigational use of the drug according to the procedures described in a special treatment protocol. This allows treatment for certain 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.