German pharmaceutical company Bayer has temporarily suspended the global marketing of Trasylol, an anti-bleeding drug used for heart patients that has been linked to a higher risk of death.

Bayer announced Monday that it would temporarily pull the drug from the market and that the decision was made following requests from regulators from Germany, the U. S., and elsewhere. The suspension of global marketing will remain in place until final results of a Canadian study on the drug will be ready, Bayer said in a statement.

This BART study is an independent randomized, controlled trial conducted on high-risk cardiac surgery patients, the statement said.

Approved in 1993, Trasylol is used during heart bypass surgery to reduce bleeding and prevent blood loss in patients with an increased risk for blood loss during the procedure. It is generically known as aprotinin.

Bayer said a reevaluation of the temporary market suspension will be conducted once the complete BART dataset is available. “Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol,” Bayer said Monday.

The data are now being collected from centers throughout Canada. A final analysis will soon follow, which is expected to take up to eight weeks or longer, Bayer said. “Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling,” the company added.

Meanwhile, Bayer will continue to work with the U. S. Food and Drug Administration, with Health Canada and other health authorities for special use of Trasylol with certain patients.

The FDA confirmed this collaboration with Bayer in a statement. “Until FDA can review the data from the terminated study, it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits outweigh the risks,” an FDA statement said.

"Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol,” the agency added.

The FDA previously said in October that Trasylol had been linked to less serious bleeding but at the same time to more deaths.

Trasylol global sales in the first nine months of 2007 were around 93 million euros, including about 63 million euros from the United States and 5 million euros in Germany, the pharmaceutical company added.

For more information and a complete statement from the company, go to http://www.trasylol.com/.