May 14, 2008 - All Trasylol Pulled from Market
The FDA and Trasylol manufacturer Bayer HealthCare Pharmaceuticals Inc. announced that the company will begin removing any remaining stock of the blood-clotting medication from the U.S. market, after detailed results of a Canada drug study showed an increased risk of death in Trasylol patients. (Read the FDA News Release on Trasylol's removal)
November 5, 2007 - Trasylol Sales Suspended Worldwide
Trasylol manufacturer Bayer AG announced that it is suspending worldwide sale of the drug until results of a recent drug trial could be properly evaluated. In October 2007, a Canada-based drug study of cardiac surgery patients was halted because Trasylol use appeared to cause increase health risks compared with other anti-bleeding drugs used in the study -- including risk of kidney failure, stroke, and heart attack. (Read the Bayer Press Release)
October 25, 2007 - Trasylol Study Halted Due to Health Risks
A Canadian study of the safety of Trasylol (Aprotinin injection) was halted because the drug appeared to increase the risk for death compared to other antifibrinolytic drugs used in the study, according to announcements from Trayslol manufacturer Bayer AG and the U.S. Food and Drug Administration (FDA). Trasylol is a medication that is administered to patients during certain types of heart surgery, to control bleeding. FDA also announced that it will conduct additional research on benefits and risks of Trasylol use.
September 12, 2007 - FDA Panel: Trasylol Should Stay on Market
A U.S. Food and Drug Administration (FDA) advisory panel recommends that Trasylol (Aprotinin injection) should remain on the market despite known health risks. Trasylol is a blood-clotting medication given to patients during certain types of heart bypass surgery, to reduce bleeding and the need for blood transfusions. A number of studies have linked Trasylol use to serious side effects including kidney damage, heart attack, and stroke.
December 15, 2006 - Revised Labeling for Trasylol
The U.S. Food and Drug Administration (FDA) approves new labeling for Trasylol (Aprotinin injection), limiting its use to specific situations and strengthening safety warnings. The new labeling specifies that Trasylol should only be given to patients who are at increased risk for blood loss and blood transfusion during coronary bypass graft surgery (a procedure used to improve blood flow to the heart). The new labeling also includes a warning that Trasylol increases the possible risk of renal dysfunction (kidney damage).
Read the FDA announcement: FDA Revises Labeling for Trasylol
January 26, 2006 - Study Links Trasylol to Serious Health Risks
A New England Journal of Medicine report suggests that Trasylol (Aprotinin injection) use may increase the risk of serious side effects among some patients undergoing coronary artery bypass grafting (CABG). The study describes the occurrence of serious kidney damage, heart attack (myocardial infarction) and stroke among CABG patients receiving Trasylol. More patients receiving Trasylol experienced these events than patients receiving either no medications intended to decrease blood loss, or other medications intended to decrease blood loss. Another study suggests that patients receiving Trasylol may be at higher risk for kidney damage. This report (published January 20, 2006 in the on-line edition of Transfusion) used methods similar to those used in The New England Journal of Medicine study but included a smaller number of patients.
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