On November 5, 2007 the FDA issued a marketing suspension for the anti-bleeding drug Trasylol. Trasylol (aprotinin injection) is approved for use in cardiopulmonary bypass in the course of coronary artery bypass graft (CABG) surgery. The drug has been approved for use since December of 1993. It has been used in surgeries around the world. The FDA is investigating reports that 235 people died in the United States after receiving Trasylol in surgeries from 1993 to February 2006.The marketing suspension was issued after a study was suspended early after test data showed that Trasylol increased the risk of death by 50 percent compared to two other drugs in the same class. The study was performed by researchers in Canada. The study analyzed data from over 3,000 cardiac surgery patients since 2002. The results were so drastic that the study was halted, and no new patients were enrolled pending further analysis. Trasylol has been linked to an increased risk of kidney failure, heart attack and stroke.
The BART studied prompted the removal of Trasylol from countries around the world. The European Union, Great Britain, China and many other counties all joined the United States in the marketing suspension. The FDA has recommended that surgeons weigh carefully the use of existing stock of Trasylol on high risk patients.