US FDA to re-evaluate Bayer's Trasylol after panel warns of 'risk of death'

-CNN

10/25/2007 - The US Food and Drug Administration said it will re-evaluate Bayer AG's (NYSE:BAY) Trasylol blood-clotting injection after an independent panel on drug safety warned it of an increased risk of death from the drug.

The Data Safety Monitoring Board (DSMB) recommendation to stop patient enrolment in a study to compare Trasylol with other antifibrinolytic drugs, the FDA said on its web site.

Trasylol, which is given before coronary bypass surgery to prevent excessive blood loss, was associated in the study with 'more deaths due to haemorrhage' compared with other blood-clotting drugs, the FDA added.

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