December 30, 1993 - Aprotinin (Trasylol) Receives FDA Approval
The Food and Drug Administration Announces approval of Trasylol, a drug that can reduce the need for blood transfusions in patients undergoing heart bypass surgery. The FDA stated that the use of aprotinin should be reserved for high risk patients. Trasylol kidney failure was reported as a problem in some patients during clinical trials.

January 20, 2006 - Association between Trasylol and Kidney Failure occurrs
The journal Transfusion publishes article, January 20, 2006, Karkouti, et al., suggesting an association between aprotinin administration and renal (kidney) toxicity among patients undergoing open heart surgery with cardiopulmonary bypass.

January 26, 2006 - Risks Associated with Trasylol in Cardiac Surgery
The New England Journal of Medicine publishes an article by Mangano et al. reporting an association of Trasylol (aprotinin injection) with serious kidney problems and heart attacks. The study found that patients who were given Trasylol were more than twice as likely to have kidney failure requiring dialysis, a 55% increase of heart failure and a 181% increase in stroke. The authors advised against further use of the drug, since safer, cheaper heart surgery drug alternatives are available.

February 8, 2006 - FDA Advisory - Trasylol Heart Surgery
Following two studies associating the use of Trasylol with increased risk of kidney failure, heart and central nervous problems after heart surgery, the FDA issued its first public health advisory regarding Trasylol. The FDA recommended limiting Trasylol use to those situations where the clinical benefit of reduced blood loss outweighs the potential risks.

September 21, 2006 -Cardiovascular and Renal Drugs Advisory Committee
The FDA holds a public meeting to discuss the safety and overall risk-benefit profile for Trasylol. The committee supports acceptable safety and efficacy for Trasylol among coronary artery bypass graft (CABG) surgery patients.

September 27, 2006 - Bayer Reveals Additional Trasylol Study
Bayer Pharmaceuticals tells FDA that it had conducted an additional safety study of Trasylol that shows use of Trasyol may increase the chance for death, serious kidney damage, congestive heart failure and strokes. The failure of Bayer to disclose the data from the additional study seriously undermined the advisory committee process and delayed the safety review.

September 29, 2006 - FDA Advisory - Trasylol Kidney Failure
FDA announces that Bayer did not reveal a safety study of Trasyol prior to the September 21, 2006 public meeting regarding the safety of Trasylol. The FDA warns physicians who use Trasylol to carefully monitor patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain, and promptly report any adverse event information to Bayer Pharmaceuticals or to the FDA.

November 5, 2007 - FDA requests marketing suspension of Trasylol
FDA Announces that based upon the data that they received from various Trasylol studies, they had requested Bayer cease marketing activity of Trasylol. The FDA could not identify a specific patient population where they believed the benefit of using Trasylol outweighs the risk associated with the drug.