On November 5, 2007, Bayer AG suspended worldwide sales of Trasylol, a clotting drug used during heart surgery to prevent bleeding, in response to concerns over a possible increased risk of death. The FDA requested such a removal after trials of the drug showed that the drug increased the risk of death, kidney damage, congestive heart failure and stroke.
What is Trasylol?
Trasylol works to slow or prevent bleeding, and is used to reduce blood loss and the need for blood transfusion during some types of heart surgeries. Commonly known as aprotinin, Trasylol is a naturally-occurring enzyme made from the lung tissue of cattle.
Side Effects of Trasylol
Trasylol has been associated with an increased risk of kidney failure, heart attack, stroke and other serious adverse events.
Bayer removes Trasylol worldwide - a timeline
1959 - Bayer AG brings Trasylol to market in Germany
1970's - German researchers begin to suspect that Trasylol causes kidney problems.
1980's - Dr. Juergen Fischer, the Director of the Institute for Experimental Medicine at the University of Cologne presented Bayer AG with evidence of Trasylol's kidney toxicity.
1993 - FDA approves Trasylol.
2005 - After twelve years on the market in the U.S., Trasylol is now used in 1/3rd of all coronary artery bypass graft (CABG) surgeries. Bayer estimates that sales of Trasylol would hit $600 million by 2006.
January 2006 - The New England Journal of Medicine publishes an article by Dr. Dennis Mangano reporting an association of Trasylol with serious renal toxicity and ischemic events in patients undergoing coronary artery bypass grafting surgery. FDA continues to evaluate Trasylol, but recommends physicians monitor patients on Trasylol carefully as well as limit its usage.
Dr. Mangano estimated that replacing Trasylol with other drugs would prevent 9,790 complications necessitating dialysis per year.
September 21, 2006 FDA holds a public meeting to discuss the safety and overall risk-benefit profile for Trasylol.
September 27, 2006 - Bayer tells the FDA that it had conducted an additional safety study of Trasylol which found that Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.
November 2007 - Trasylol is pulled from the market. According to Dr. John K. Jenkins, director of the FDA's Office of New Drugs, "the FDA cannot identify a patient population in which the use of Trasylol outweighs the risk."
February 2011 - In Bayer's 2010 Annual Report, Bayer reports there were approximately 1,100 lawsuits pending in the US as a result of injuries including renal failure and and death. As of 2/2011, Bayer had reached agreements with approximately 440 plaintiffs.