The timeline below includes major Trasylol events, from FDA approval to the announcement of a new study that states the increased risks of congestive heart failure, stroke, kidney dysfunction, and death with the use of Trasylol.

December 30, 1993 – Aprotinin (Trasylol) Receives FDA Approval

The Food and Drug Administration announces approval of aprotinin, 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. Kidney toxicity was reported as a problem in some patients during clinical trials.

January 20, 2006 – Association Between Aprotinin and Renal Toxicity

The journal Transfusion publishes article, January 20, 2006, Karkouti, et al., suggesting an association between aprotinin administration and renal (kidney) toxicity among patients undergoing cardiac surgery with cardiopulmonary bypass.

January 26, 2006 – Risks Associated with Aprotinin 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 aprotinin 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 alternatives are available.

February 8, 2006 – FDA Public Health Advisory

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 a public health advisory. 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 I 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 Public Health Advisory

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.