The European Medicines Agency (EMEA) has recommended the suspension of all marketing of medications containing aprotinin for systemic use. Aprotinin (Trasylol) 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 medicines are greater than their benefits, and that all marketing of aprotinin in Member States by suspended.
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 the aprotinin containing drugs 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, showing increased mortality for patients receiving Trasylol. The study was halted and the manufacturer, 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 a loved one has been injured by the administration of Trasylol (aprotinin) during heart bypass surgery, please contact one of our attorneys at Specter, Specter, Evans, and Manogue, P.C.
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