Subject: FDA- MedWatch- Aprotinin Injection (marketed as Trasylol)- Patient Enrollment In The Aprotinin Treatment Group Arm of BART Study Stopped
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals of the Data Safety Monitoring Board's recommendation to stop patient enrollment in the aprotinin treatment group arm of the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study. The BART study was designed to test the hypothesis that aprotinin was superior to epsilon-aminocaproic acid and tranexamic acid in decreasing the occurrence of massive bleeding in association with cardiac surgery. The preliminary findings suggest that, compared to the antifibrinolytic drugs, epsilon-aminocaproic acid and tranexamic acid, aprotinin increases the risk of death.
FDA anticipates re-evaluation of the overall risks and benefits of Trasylol which may result in the need to revise the prescribing information or other regulatory actions. Healthcare professionals who are considering use of Trasylol should be aware of the risks and benefits described in the prescribing information for Trasylol and the accumulating data suggesting Trasylol administration increases the risk of death compared to other antifibrinolytic drugs.
Read the complete MedWatch 2007 Safety Summary including a link to Early Communication information regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Aprotinin
