Trasylol Faces New Safety Scrutiny
Big changes may be coming for the leading injection drug used to prevent blood loss during heart bypass surgery. The preliminary results of a Food and Drug Administration (FDA) study found that Trasylol increases the risk of patient death compared to other similar blood loss drugs.
Known generically as aprotinin, Trasylol has been under the FDA’s close watch since two February 2006 studies linked the drug to dangerous side effects such as kidney failure, heart attack, and other adverse events. This prompted a Public Health Advisory, which was issued to healthcare professionals.
The current study findings affirm that Trasylol has a significant trend towards increased mortality. Although there was less bleeding when patients used Trasylol, there were many more deaths due to hemorrhage. Due to these findings, the FDA has announced that it will re-evaluate the blood loss medication. Potentially, there are label changes and other safety restrictions in store for Trasylol.
Source: "Early Communication about an Ongoing Safety Review Aprotinin Injection marketed as Trasylol." FDA Report. October 25, 2007.