Bayer Trasylol trial halted, FDA advises doctors

(Recasts with Bayer statement, adds details from FDA notice, background)

By Kim Dixon

WASHINGTON, Oct 25 (Reuters) - A trial of Bayer AG's (BAYG.DE: Quote, Profile, Research, Stock Buzz) heart surgery drug Trasylol was halted after an increased risk of death from bleeding was linked to the treatment, the company said on Thursday.

The drug, approved in 1993 and known generically as aprotinin, has been under a cloud for more than a year amid data suggesting it may boost the risk of death, serious kidney damage and stroke.

The U.S. Food and Drug Administration advised doctors in a notice posted on its Web site on Thursday to be aware of the "accumulating data suggesting" an increased mortality risk.

The FDA said it will revisit the drug's safety, which may include label changes or other regulatory actions.

Trasylol is aimed at preventing blood loss in patients with an increased risk for blood loss during heart bypass surgery.

Bayer said it still backs the safety of the drug, and that it is cooperating with the FDA and other health regulators to "reevaluate" its risks and benefits.