Bayer suspends Trasylol sales

Bayer has announced the decision to temporarily stop selling Trasylol (aprotinin injection) following consultation with a number of health authorities worldwide, including the German Federal Institute for Drugs and Medical Devices, Health Canada and the US Food and Drug Administration.

The firm will temporarily suspend marketing of the drug until it collates and assesses the final results of the Canadian Bart trial.

Moves by the company to halt the sale of Trasylol follow notifications made to the company that the executive committee of the Bart study have stopped the trial after data analysis showed reduced bleeding but also a rise in all-cause mortality in patients receiving aprotinin.

“Once more complete information is available from Bart investigators and a thorough evaluation can be conducted by Bayer and global health authorities, the company will communicate publicly regarding any further actions that may be undertaken in response to the analysis of that information,” the company reports.

Bayer claims that the full available data regarding the drug will support a positive risk-benefit profile for the compound.

Trasylol is indicated as a prophylactic treatment for the reduction of perioperative blood loss and the likelihood of blood transfusion in patients at an increased risk of blood loss undergoing a cardiopulmonary bypass as part of their coronary artery bypass graft surgery.