Just a few weeks after Bayer decided to halt global marketing of Trasylol, advisors to Europe’s regulators has issued a statement saying that the blood loss agent should indeed be pulled.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has concluded that the benefits of systemic formulations of Trasylol (aprotinin) “no longer outweigh their risks” and it has recommended that all marketing authorisations should be suspended throughout
Europe.

The CHMP has been reviewing the drug since November 5, when the German medicines regulatory authority suspended marketing authorisation for Trasylol, used as an infusion during bypass surgery. This decision was triggered by the preliminary results of the Canadian Phase III BART study, which is looking at the use of aprotinin in around 3,000 heart surgery patients to reduce post-operative bleeding.

That study was stopped after preliminary findings indicated a higher risk of death compared to two antifibrinolytic drugs used in the study, epsilon-aminocaproic acid and tranexamic acid. Bayer then responded by taking the drug off the market until it has analysed all the data.

The CHMP has looked at the data that its Pharmacovigilance Working Party (PhVWP) has already been considering in the context of its monitoring of the safety of medicines, plus new information from the BART study. It says that the PhVWP review had already identified some concerns and now the extra data has convinced the agency’s committee to recommended that Trasylol be suspended in all European Union and European Economic Area markets.

Bayer has still not given up on the drug and Bayer Healthcare chairman Arthur Higgins recently told PharmaTimes World News that it is waiting for the full data from BART to be evaluated which could take up to another month. However he noted that the US Food and Drug Administration has twice recently said that available data continue to support a favourable risk-benefit profile for Trasylol when used according to labelling.