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Bayer Trasylol trial halted, FDA advises doctors

Oct 29, 2007 | Associated Press | Reuters News

A trial of Bayer AG's (BAYG.DE: Quote, Profile, Research) 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.

The FDA said in its notice to doctors 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.

An FDA advisory panel last month 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. 

The drug's labeling was revised last year to narrow its use to patients with an increased risk of blood loss and transfusion, a warning that has substantially cut its use.

Bayer has previously said it mistakenly withheld a study of 67,000 hospital records suggesting Trasylol may boost the risk of death, serious kidney damage, congestive heart failure and stroke.