Study that showed heart surgery drug increased the risk of death was flawed according to the European regulator
Bayer’s suspended heart surgery drug Trasylol should be allowed back on the European market, according to the European Medicines Agency (EMA).
The regulator said that the benefits of all antifibrinolytic medicines, which inhibit the body’s process that prevents blood-clotting, outweigh the risks in certain indications to prevent excessive blood loss during surgery.
Trasylol was pulled from the market by Bayer in 2007 after preliminary results from the BART study appeared to show an increased mortality rate in patients who had taken the drug compared to those who hadn’t.
This was followed by a further assessment of the study published in the New England Journal of Medicine (NEJM) in 2008 that backed the preliminary findings, causing the EMA to suspend marketing authorisation.
However, a review from the EMA’s Committee for Medicinal Products for Human Use (CHMP), published February 17, 2012, found a number of faults with how the BART study was conducted, and that its results could not be replicated in further investigations.
Flaws included imbalances in the methods of using blood-thinning medications to counter the clotting effects of Trasylol, improper monitoring of the use of medicines, and issues with the exclusion of some patient data.
The EMA has now recommended Trasylol should be available for use in a narrow group of patients undergoing isolated heart bypass surgery who are at high risk of major blood loss, but only after an assessment by a doctor and consideration of alternative treatments.
A registry to keep track of information concerning Trasylol is also part of the CHMP’s proposals, which will now be considered by the European Commission (EC) before implementation.
According to Reuters, Bayer will wait for the EC’s decision before making any decision whether to try and relaunch the drug in Europe.
The EMA’s announcement follows a decision from Health Canada, the healthcare regulator for Canada, to lift its own suspension of Trasylol in September, 2011.