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FDA Video: Marketing of Trasylol Suspended

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On May 14, 2008, Bayer Pharmaceuticals notified the U.S. Food & Drug Administration (FDA) that they would be initiating a nationwide Trasylol recall.  Included below is a video issued from the FDA regarding the Trasylol recall.

Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses. 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 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.

Bayer Pharmaceuticals has suspended the marketing of Trasylol (aprotinin) which is used to reduce perioperative blood loss during cardiac surgery with cardiopulmonary bypass. Preliminary results of a Canadian study indicate that while patients given Trasylol experience fewer serious bleeding events, they may also have a greater risk of death than patients taking either of two other antifibrinolytic drugs.

Sales of Trasylol will be suspended until FDA can conduct a thorough analysis of the study and gain a better understanding of the risks and benefits of the drug. Because there are few treatment options for patients at risk for excessive bleeding during cardiac surgery, FDA is working with Bayer to gradually phase Trasylol out of the marketplace so that it doesn’t cause shortages of other drugs used for this purpose.

FDA is also exploring ways that physicians may continue to have access to Trasylol in specific cases where the benefits of the drug outweigh the risks.

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