Is Aprotinin (Trasylol) Safe to Use?

According to an United States Food and Drug Administration (FDA) press release, the drug Aprotinin (Trasylol) is being analyzed in regard with safety issues associated with the use of it in heart surgery. That is why the FDA has issued an issued an Early Communication about an Ongoing Safety Review of Aprotinin Injection.

A Canadian research group was using the drug in a clinical trial and stopped using it (actually ended the study) because there was a significantly and abnormally higher rate of death among clinical trial participants. This fact prompted the Canadian group to notify the FDA for the possibility of the drug being unsafe and posing risks for it users.

More specifically the Early Communication about an Ongoing Safety Review Aprotinin Injection stated the reasons of the FDA action on this drug:

*The 30- day mortality in the aprotinin was significantly higher when compared to other drugs being tested in the study (aminocaproic acid or tranexamic acid)

*An increased mortality trend was observed in the aprotinin group throughout the study;

*People receiving aprotinin died (due to hemorrhage) more frequently

*The Data Safety Monitoring Board's (DSMB) concluded that the enrollment of more patients into the aprotinin group would not significantly change the study findings.

The aprotinin drug (Trasylol), marketed by Bayer Pharmaceuticals Corp., Germany, pertains to a group of drugs known as antifibrinolytic drugs.

Antifibrinolytic drugs are said to reduce excessive bleeding by slowing the breakdown of blood clots that could have formed during heart surgery. Trasylol is currently approved for to reduce blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass.

This is not the first time Aprotinin has shown adverse effect on patients. As a matter of fact the FDA was aware of possible safety issues about drugs before. As a matter of fact and according to the press release, A September 2007 joint meeting of FDA's Cardiovascular and Renal Drugs and Drug Safety and Risk Management Advisory Committees were already talking about these safety issues of the aprotinin drug.

The FDA had already received information about adverse effects caused by Trayslol. That is why the Early Communication issued by the FDA is the first step in a formal procedure to review the safety and efficacy of the drug.

FDA believes that after a formal FDA safety review of the drug additional actions will be taken. It could be additional labeling of the risk associated with the drug and even possible unauthorization of the use of the drug.

Sources:

FDA Issues Early Communication About an Ongoing Safety Review of Aprotinin Injection. FDA press release. URL: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01733.html

FDA. Early Communication about an Ongoing Safety Review Aprotinin Injection (marketed as Trasylol) URL: http://www.fda.gov/cder/drug/early_comm/aprotinin.htm