EMA recommends restoring blood loss drug to market

The European Medicines Agency (EMA) has recommended lifting the suspension of blood loss restricting medicine Trasylol (injectable aprotinin), denied EU marketing authorisation since 2008.

The review stated that the results of the BART study, on which the suspension was based, were unreliable and not supported by later studies.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Trasylol’s benefits outweigh its risks in a more narrowly defined group of patients than before.

The review examined the benefits and risks of all antifibrinolytic drugs, which prevent excessive blood loss by helping to preserve blood clots.

Before its suspension in 2008, Bayer’s Trasylol was authorised in the EU for patients undergoing heart bypass surgery, reducing the risk of major bleeds.

The CHMP concluded that the drug has a positive benefit-risk balance in patients undergoing isolated heart bypass surgery who are at high risk of major blood loss.

Trasylol sales were suspended in May 2008 on the recommendation of the CHMP, following the preliminary results of the BART study with high-risk heart surgery patients, which appeared to show an increased death rate with Trasylol after 30 days relative to other medicines.

The current review compared the final results of the BART study with those of other clinical studies and wider research and clinical data. It concluded that the BART study did not take account of imbalances in the use of blood-thinning medicines such as heparin, and that its findings were not replicated in other studies.

The CHMP further recommended that doctors be warned of the importance of heparin, and that the use of Trasylol in the EU be monitored through a registry.