FDA ALERT

 

November 06, 2007

FDA MedWatch: Trasylol (aprotinin injection) - FDA requests marketing suspension and Bayer Pharmaceutical Corp. has agreed, pending a detailed review of preliminary results from a Canadian study that suggested an increased risk for death

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol (aprotinin injection), a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death. FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks.
However, understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol. There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Read the complete MedWatch 2007 Safety Summary including a link to the "FDA News" and Drug Information Page, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#Trasylol

October 25, 2007

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