The FDA in conjunction with Bayer Pharmaceuticals, has recalled Trasylol, after results showed an increased risk of death
On May 14, 2008, Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock. The FDA has agreed to work with Bayer to ensure a smooth and complete process.
FDA limits access to certain drugs to patients with serious or immediately life-threatening disease or conditions who lack other therapeutic options and may benefit from such therapies.
The Trasylol recall comes after a randomized Canadian study that prompted last November’s marketing suspension of Trasylol are expected to be published this week. The data contained in this article suggest that Trasylol appears to increase the risk for death compared to two other antifibrinolytic drugs used in the study.
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