Trasylol Clinical Trail Halted Due to Bleeding, Death RiskOct 25, 2007 | Parker Waichman LLP
A Trasylol clinical trial has been halted according to the Food & Drug Administration (FDA) because patients enrolled in the study who took Trasylol had a higher risk of death from bleeding. The FDA’s decision to end the Trasylol clinical trial is just the latest disturbing news about this defective drug, which has also been linked to kidney failure.
Trasylol, known generically as aprotinin, is marketed by Bayer AG. Trasylol was approved in 1993 and is used during heart bypass surgeries to prevent bleeding. The drug works by blocking enzymes that dissolve blood clots. Trasylol has been undergoing an FDA safety review since 2006 when studies linked the drug to serious side effects, including kidney failure, heart attacks and stroke. Last 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.
The Trasylol clinical trail that was ended had been comparing its effectiveness with similar drugs, known as antifibrinolytic drugs. According to an FDA notice, the 30-day mortality risk in the study’s Trasylol patients was nearing “statistical significance”. While the patients in this Trasylol clinical trial did experience less serious bleeding, there were more deaths due to hemorrhage in the Trasylol group.
The FDA convened an advisory panel last month to look at the drug’s safety problems, after two other studies linked Trasylol to an increased risk of death. One of those studies, 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. The I3 drug report was withheld from the FDA by Bayer prior to another September 2006 advisory panel meeting on Trasylol’s safety. Bayer claims that this was an oversight, as the company’s management was not informed of the report until after the safety review.
A second study published last year in the Journal of the American Medical Association also suggested that Trasylol increased the risk of death by about 50 percent for some patients. During that study’s five-year examination period, 223 deaths occurred among 1072 patients treated with Trasylol.
While the September advisory panel meeting ended with a recommendation that Trasylol be allowed to remain on the market, the panel also said that the drug merited further study. In issuing this latest warning, the FDA said that that doctors who are 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. The FDA said it would be reevaluating Trasylol’s safety record, and could consider making further labeling changes or taking other regulatory action.