Bayer suspends sales of anti-bleeding drug

Germany’s Bayer has temporarily suspended global sales of its anti-bleeding drug Trasylol, which has been linked to a higher risk of death, pending final results of a Canadian study on the medicine.

Trasylol is used to prevent blood loss in patients during heart bypass surgery.

The drug, approved in 1993 and known generically as aprotinin, has been under a cloud for more than a year amid data suggesting it might increase the risk of death, serious kidney damage and stroke, so the step was not unexpected.

Bayer said Monday the decision followed requests from German, U.S. and other regulators for the company to suspend the drug until final data from the Canadian study were available.

The study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients.

Once the study results are fully compiled, “Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol,” Bayer said.

In October, recruitment for the trial was halted following safety concerns linked to the treatment.

The Food and Drug Administration said at that time that the 30-day mortality risk in the Trasylol group in the trial was nearing statistical significance, compared with other treatments it was tested against. The drug was linked to less serious bleeding but more deaths due to hemorrhage in an initial analysis.

In September, an FDA panel recommended the drug stay on the market despite its risks, but urged the company to conduct a randomly controlled clinical trial, a rigorous study that is considered the gold standard for evaluating a drug.