TORONTO - Drug giant Bayer Inc. confirmed Thursday that a large Canadian-led trial studying its drug Trasylol (aprotinin) has been halted because of concerns the drug increased the risk of death among people who received it.
The U.S. Food and Drug Administration also posted a statement on the observed risk from the study, known as the BART trial, saying the agency will consider the new evidence as part of its ongoing deliberations on whether the drug should be removed from the market or have additional warnings on its label.
The drug is used to prevent massive bleeding during coronary bypass surgery.
"In light of the preliminary BART study findings, FDA anticipates re-evaluation of the overall risks and benefits of Trasylol,'' the U.S. drug regulator said.
"This re-evaluation may result in the need to revise the labelling or other regulatory actions. Until this process has been completed, health-care providers who are considering use of Trasylol should be aware of the risks and benefits described in the labelling for Trasylol and the accumulating data suggesting Trasylol administration increases the risk for death compared to other antifibrinolytic drugs.''
Bayer also issued new guidance to doctors, telling them they should only use Trasylol as directed on the drug's label while records of the multi-centre, multi-year trial are reviewed.
"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,'' the company said in a statement.
The BART trial was testing the drug against two other drugs in the same class.
The principal investigator of the trial is Dr. Paul Hebert, a researcher at the Ottawa Health Research Institute. Hebert is also editor of the Canadian Medical Association Journal.
Hebert did not immediately respond to requests for an interview.
The study's full name is "Blood Conservation using Antifibrinolytics: A Randomized Trial in High-Risk Cardiac Surgery Patients'' (BART). It is a multi-centre randomized controlled trial to compare the efficacy and safety of aprotinin, aminocaproic acid and tranexamic acid.
Approximately 3,000 high-risk cardiac surgical patients undergoing either re-operation for coronary heart bypass graft or aortic valve replacement, or combined valves or valve-graft procedures were to be randomly assigned to one of the drugs.
When a periodic analysis of data from the trial showed increased deaths among the aprotinin group, the trial's executive board decided to cut off enrolment in the study and informed drug regulators and the company.
The FDA had already been studying the drug, which has been linked to fatal cases of anaphylactic shock, kidney failure, heart attack and stroke.
An expert panel convened by the U.S. drug regulator voted in mid-September to recommend that the drug stay on the market.
The FDA's statement said it hadn't yet concluded whether the new information requires it to take regulatory action against the Trasylol.
