Trasylol (aprotinin injection) is a drug approved to reduce blood loss during cardiopulmonary bypass surgery. A study performed by the Ischemia Research and Education Foundation found that the use of Trasylol doubled the risk of kidney failure in cardiopulmonary bypass surgery patients. This study also found that the risk of heart failure more than doubled after Trasylol had been used in operation. Patients who had used Trasylol also showed an increased risk of stroke by 181 percent. In 2006, the Food and Drug Administration announced that Bayer, the drug’s manufacturer, had failed to reveal the results of the study linking Trasylol to stroke or possible death.
In February 2006, the FDA issued a public health advisory for doctors who perform heart bypass surgery and their patients about the possible side effects of Trasylol. Trasylol is the only drug approved by the FDA for the prevention of peri-operative blood loss and the need for blood transfusion among patients undergoing coronary artery bypass graft surgery. Read the FDA public health advisory concerning Trasylol.
An FDA alert issued in December 2006 for aprotinin injection marketed as Trasylol covered the new prescription revisions and new labeling for the drug. This alert also warned against renal dysfunction.
To learn more about legal claims relating to Trasylol, consult an attorney who practices in the area of drugs and medical devices.