The German pharmaceutical company Bayer has voluntarily suspended worldwide marketing of its heart surgery drug Trasylol following consultation with various country health authorities including the the German Federal Institute for Drugs and Medical Devices (BfArM), the US Food and Drug Administration (FDA), and Health Canada.

Trasylol is a heart drug designed to stop excessive bleeding during heart surgery. Recent trials on the drug at the Ottawa Health Research Institute in Canada were stopped because preliminary results showed an increased risk of death from the drug.

According to Bayer the suspension is temporary, pending final results from the Canadian trial, which is part of an international trial known as the BART trial (Blood Conservation using Antifibrinolytics: A Randomized Trial in High-Risk Cardiac Surgery Patients).

The FDA issued an Early Communication about a safety review of Trasylol on 26th October, after it was contacted by researchers at the Ottawa Health Institute about their reasons for stopping the trial. This followed a label revision last year where the safety warning for Trasylol was strengthened and approval for use was limited to patients having heart bypass graft surgery who were at increased risk of blood loss and blood transfusion during the operation.

Like Bayer, and other regulatory agencies, the FDA has not yet received the final data on the trial and therefore cannot conduct its own analysis on the risks and benefits of Trasylol for patients undergoing cardiac surgery.

In the meantime the agency said it had requested the suspension in the interests of patient safety, “based on the serious nature of the outcomes suggested in the preliminary data”. But there are few other treatment options for patients at risk of high blood loss during cardiac surgery, so the agency is working with Bayer to phase out Trasylol so it does not cause a shortage of the alternatives.

Also, there may be cases on an individual basis where doctors estimate that the benefits are likely to outweight the risks and the FDA said it will explore “ways for those doctors to have continued, limited access to Trasylol”. Bayer said it will help by outlining “appropriate patient profiles and the specific details”.

Trasylol is an antifibrinolytic, a type of drug that reduces excessive bleeding by inhibiting fibrinolysis, a natural process that breaks down blood clots.

Bayer said it will re-evaluate the suspension once it has analysed the final results of the BART trial together with the various health regulators worldwide to reassess the risk-benefit balance.

The BART trial was halted by its Executive Committee after it received the results of a periodic analysis that showed Trasylol had reduced bleeding but it was also linked with an increased risk of death due to all causes compared to patients on two other antifibrinolytics, aminocaproic acid or tranexamic acid.

Data is now being collected from the other Canadian centres, and it will be several weeks before it can be assembled for final analysis.

Over the next few days, Bayer said it will be sending information to health practitioners about the temporary suspension.

Bayer also said in a prepared statement that it “believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling”.

Click here for FDA.

Click here for Health Canada.

Click here for BfArM.

Written by: Catharine Paddock