Back to Trasylol®

The license for anti-bleeding drug Trasylol® (aprotinin) has been suspended on the advice of the Commission on Human Medicines (CHM). Global marketing of Trasylol® had already been suspended voluntarily by Bayer and Nordic Pharma due to safety concerns regarding the drug's dangerous side effects which include kidney failure, heart attack, stroke, and even death.

The CHM decision to suspend the license was made on the basis of preliminary findings from the Canadian BART study, which was stopped early after excess death rates were observed with aprotinin compared to two other drugs tranexamic acid and aminocaproic acid.

In addition, data from observational studies suggested an increased risk of mortality as well as an increased risk of stroke, heart attack, and kidney failure.

Trasylol® is indicated for the reduction of blood loss and need for blood transfusion in coronary artery bypass graft surgery.

The CHM concluded that although aprotinin may be more effective than comparative drugs at reducing bleeding, the risks outweigh the benefits.

Reference:

"Trasylol license suspended," healthcarerepublic.com, December 2007.