Trasylol Trial Stopped Over Increased Death Risk
Bayer AG announced yesterday that it was halting a clinical trial of its heart surgery drug Trasylol because of evidence of an increased risk of death from hemorrhaging.
Trasylol , generically known as aprotinin, gained approval by the Food and Drug Administration in 1993 for preventing blood clots in certain heart bypass patients. Over the past year, however, the drug’s safety has come into question.
Accumulating Data
Data from previous studies has suggested that Trasylol raises the risk of kidney damage, stroke, and death. On Thursday, the FDA posted a statement on its website warning doctors of “accumulating data suggesting” an increased death risk.
Last year, a warning was added to the drug’s label to limit its use to patients with a higher risk of blood loss during heart surgery. Despite its risks the drug has remained on the market, though an FDA advisory panel last month urged Bayer to conduct a rigorous clinical trial.
Bayer knew about the possible increased risk of death associated with its drug, and admitted to withholding a study of nearly 70,000 hospital records suggesting that risk. The company blamed the failure to disclose the study on a “regrettable human error.”