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Trasylol Deaths Exceed 200, FDA Says

Nov 19, 2007 | Parker Waichman Alonso LLP

Trasylol, a defective drug made by Bayer AG, may have killed more than 200 people, according to the Food & Drug Administration (FDA).  Trasylol, used to prevent bleeding during heart surgeries, was pulled from the market earlier this month, after it was linked to an increased risk of death.

The FDA had asked Bayer to suspend sales of Trasylol, known generically as aprotinin, after a clinical trial involving the drug was halted.  The Canadian Data Safety Monitoring Board had stopped the Trasylol trial after a data analysis indicated that the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. While the patients in the Trasylol clinical trial did experience less serious bleeding, there were more deaths due to hemorrhage in the Trasylol group.  When news of the Canadian trial broke, the FDA initially issued guidelines that said doctors who were considering using Trasylol should be aware of the risks and benefits of the drug, as well as the accumulating data suggesting Trasylol increases the risk of death compared to other antifibrinolytic medications.   But a few days later, the FDA and Bayer agreed that sales of Trasylol would be suspended while the agency reviewed its safety.

Over the weekend, the “New York Post” published a report that Trasylol has been linked to more than 200 deaths.  According to the newspaper, The FDA received 235 reports "that noted death in patients who received Trasylol" to control bleeding during heart-bypass surgery from 1993, when the drug was approved, through February 2006.  The FDA was unable to confirm the exact number of deaths for the past 19 months, the newspaper said.   The number of Trasylol death reports was expected to jump during that period following several studies warning the drug could cause kidney damage, stroke and heart failure.

Trasylol was approved in 1993 and is used during heart bypass surgeries to prevent bleeding. Last year, a study published in the Journal of the American Medical Association found that Trasylol increased the risk of death by about 50 percent for some patients. A second 2006 Trasylol study, known as the I3 drug report, suggested that Trasylol increased the risk of a patient dying by 54 percent. That study, which analyzed a database of hospital patients treated with the drug, suggested that Trasylol could also increase the likelihood of serious kidney damage, congestive heart failure and strokes.

In December, the FDA updated the Trasylol label to include a black box warning – the agency’s strictest safety notice – stating that the drug placed patients at a high risk of kidney failure. The black box warning also cautioned that the use of Trasylol should be reserved only for patients who were at risk for significant blood loss during bypass surgeries. In September, an FDA advisory panel agreed with the assessment that Trasylol had a high risk of causing serious side-effects, and it recommended that Trasylol undergo further clinical testing. However, the FDA panel also voted that Trasylol should stay on the market.  

But the evidence of an increased death rate found by the Canadian Trasylol trial was more than the FDA could ignore, and the agency took the drastic step of asking Bayer to remove it from the market.  It is not known when – or if – Bayer will be able to market Trasylol again.