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Aprotinin side effects have caused the European Medicines Agency (EMEA) to recommend the suspension of all marketing of medications containing aprotinin. Aprotinin (marketed as Trasylol7reg;) is used to reduce blood loss and the need for blood transfusion in patients undergoing heart bypass surgery.

Following a review during its November 2007 meeting, the Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the risks of these drugs are greater than their benefits, and that all marketing of aprotinin in Member States should thus be suspended immediately.

Aprotinin containing medications are currently available in Austria, Belgium, Bulgaria, the Czech Republic, Cyprus, Germany, Denmark, Greece, Estonia, Finland, France, Hungary, Lithuania, Luxembourg, Latvia, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, and Sweden.

The CHMP recommendation follows the suspension of aprotinin for systemic use in Germany in November of 2007. The German National Competent Authority based its decision on newly available interim results from the Canadian BART clinical trial, which showed increased mortality for patients receiving Trasylol®. The study was halted and Bayer suspended the worldwide marketing and sales of its aprotinin-containing medicinal products, Trasylol® and Trasynin®.

The CHMP reviewed the preliminary results from the BART study as well as at the results of a number of safety observational studies. The Committee concluded that the risks of aprotinin containing medications for systemic use outweigh their benefits.

The CHMP opinion will now be sent to the European Commission for the adoption of a decision, applicable in all EU markets.

If you or someone you know has undergone a coronary artery bypass graft surgery and subsequently developed kidney damage or failure due to the administration of Trasylol®, please use the form on the left to contact one of our attorneys.