Trasylol (Bayer HealthCare) reinstated for Cardiac Surgery in the EU

The European Commission has approved the reinstatement of the marketing authorisations for Trasylol (aprotinin), from Bayer HealthCare, for use in Cardiac Surgery in European Union. This confirms the opinion of the CHMP from May 2013, recommending these reinstatements. The recommendation took into account a full and independent review of the benefits and risks of aprotinin, which found that the results of the study, on which the suspension of aprotinin was based, were unreliable.

The drug was temporarily withdrawn worldwide in 2007 after studies suggested that its use increased the risk of complications or death; this was confirmed by follow-up studies. Trasylol was entirely and permanently withdrawn in May 2008, except for very restricted research use.