Bayer HAS announced new guidance to physicians and health care providers regarding the use of Trasylol (aprotinin injection) in patients at an increased risk of blood loss and blood transfusion undergoing coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass (CPB).
The company did so after being notified that the BART executive committee had halted the Canadian-based trial a randomized, controlled trial being conducted in high-risk cardiac surgery patients. This followed a letter from the BART Data Safety Monitoring Board informing the Committee that a planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality (that almost reached conventional statistical significance for 30-day mortality) for patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid. Data have not, as yet, been shared with Bayer.
Bayer immediately informed the US Food and Drug Administration (FDA), Health Canada and other health authorities around the world.
Bayer has also been informed that data will now be collected from all centres throughout Canada and data analysis will be undertaken by those conducting the BART study - a process that is expected to take between four and eight weeks. Consequently no further evaluation either by Bayer or by regulatory authorities can take place until additional information becomes available from the BART investigators.
Guidance from Bayer includes a recommendation that physicians use Trasylol only in accordance with approved product labeling. Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.
Additionally, when deciding to prescribe Trasylol, physicians should also take into consideration that the BART Trial has been halted due to an increase in all-cause mortality in patients in the aprotinin treatment arm compared to patients who received either aminocaproic acid or tranexamic acid.
Patient safety remains Bayer's primary concern. Bayer believes Trasylol remains a safe and effective treatment option for physicians. Bayer will continue to work closely with medical experts, the FDA and health authorities in countries where Trasylol is marketed to re-evaluate the overall risk-benefit of the product and will evaluate the need for a label change and/or other actions as additional data and analyses become available from the BART trial.
Trasylol administration may cause fatal anaphylactic or anaphylactoid reactions. Fatal reactions have occurred with an initial (test) dose as well as with any of the components of the dose regimen. Fatal reactions have also occurred in situations where the initial (test) dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is increased among patients with prior aprotinin exposure and a history of any prior aprotinin exposure must be sought prior to Trasylol administration.