Back to Trasylol®

Trasylol®, Bayer's heart surgery drug, appears to increase the risk of risk of death according to recent documents released by U.S. regulators.

A Food and Drug Administration (FDA) advisory panel will once again review the safety of Trasylol®, following the surfacing of troubling data just days after another FDA advisory panel met last year over the drug's safety.

That first advisory panel found Trasylol®, used to control bleeding during heart surgery, was only acceptable for certain patients.

Bayer recently said it mistakenly withheld a study of 67,000 hospital records suggesting the drug could increase the risk of death, kidney damage, congestive heart failure and stroke.

FDA staff said the totality of three recent Trasylol® studies support the risk of renal failure and dysfunction, and noted a "mortality disadvantage detected" in a Bayer study.

Trasylol®, also known as aprotinin, was approved in 1993 and is given by to prevent blood loss during coronary artery bypass graft surgery.

Wall Street analysts originally forecast that Trasylol® could generate sales of more than $500 million, but those estimates have been lowered amid the safety issues and FDA label warning that was added last year.

Bayer has said it did not share the findings with the FDA because they were preliminary, though it has suspended two senior staffers over the issue.

The first FDA panel in September 2006 was reviewing data from medical journals that suggested Trasylol® might increase the chance of kidney damage, heart attacks and strokes.

Reference:

"Bayer's Trasylol may boost death risk: FDA staff," Reuters, Kim Dixon, September 2007.