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The German drug company Bayer has suspended worldwide marketing of Trasylol (aprotinin), its antifibrinolytic drug, after the requests of the drug regulating authorities in Germany and Canada and the advice of the Food and Drug Administration in the United States. Infusions of aprotinin have been used to stop excessive bleeding during heart surgery.
A recent Canadian trial known as the BART trial (blood conservation using antifibrinolytics: a randomised trial in high risk cardiac surgery patients), coordinated by the Ottawa Health Research Institute, was stopped because preliminary results showed an increased risk of death from the drug. The trial was started in 2001 and includes 3000 patients undergoing heart surgery.
Initial results had shown that Trasylol had lessened bleeding but the drug was linked to increased risk of death from all causes compared with patients taking two other antifibrinolytics—aminocaproic acid or tranexamic acid.
Bayer has announced that the suspension is temporary, until the final results from the BART trial are available, which is not likely to be until the end of 2008. The FDA issued a statement that because “there are not many treatment options for patients at risk of excessive bleeding during cardiac surgery” the FDA was “working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.” However, the German Federal Institute for Drugs and Medical Devices insisted on an immediate suspension because alternative drugs were available in Germany.
Trasylol was registered by the FDA in 1993 and was given in 2006 to about 200000 patients worldwide, 110000 of them in the US, with total sales amounting to about €150m (£110m; $220m) a year.
The BART study was the latest in a series of worries about Trasylol's safety in past years. In 2006 a study published in the New England Journal of Medicine showed increased risks of kidney failure, heart attack, and stroke (2006;354:353-65).
As a result, safety warnings for Trasylol were strengthened in 2006, and approval for use was limited to patients who were having heart bypass graft surgery and were at increased risk of blood loss and blood transfusion during the operation.
In October 2006 international drug regulators' worries heightened when it became known that Bayer had failed to disclose to the agencies or their advisory panels the results of an unpublished study that had been sponsored by Bayer. Indeed, Bayer scientists had defended Trasylol at an FDA panel hearing but had not mentioned their own study.
Bayer announced that it regretted the mistake and that according to an internal investigation the findings of the trial had been withheld by two Bayer employees and not been passed on as necessary.
“The results of this trial is still being discussed with the experts and is not yet public,” said Michael Diehl, press officer of Bayer Health Care.