Trasylol Recall
On November 5, 2007, Bayer agreed to a Trasylol recall or as it was announced by the Food and 
Drug Administration, a “marketing suspension” of its heart surgery drug which has been associated with serious risks such as kidney failure, heart problems and death. Trasylol is a drug that was designed to control bleeding during heart surgery. Two weeks before the FDA’s announcement, researchers from the Ottawa Health Institute notified the FDA that they had stopped a study on Trasylol because it appeared to increase the risk of death for patients, compared to two other drugs used in the study.
Dr. Dennis Mangano, a medical researcher had published a revealing study in the New England Journal of Medicine in January 2006 prior to the Trasylol recall. His study showed that patients who had been given Trasylol had twice the rate of kidney failure and an increased risk of strokes, heart attacks and encephalopathy (a type of brain disease).
After the Trasylol recall, two studies published on February 28, 2008 in the New England Journal of Medicine confirmed that bypass patients who were given Trasylol had an increased risk of death. The release of these studies follows an interview of Dr. Dennis Mangano on the TV show 60 Minutes. Dr. Mangano stated that in his opinion the FDA should have pulled Trasylol from the market after his study was released in January 2006. It is estimated that approximately 413,000 patients received Trasylol between the time of his study and the time of the recall. According to Dr. Mangano, 22,000 lives could have been saved if the drug had been taken off the market in January 2006.
