Trasylol, a drug used to prevent bleeding during heart surgery, was removed from the market by Bayer AG earlier this month after it was linked to a risk of sudden death. According to the Food & Drug Administration, Trasylol may have been responsible for more than 200 fatalities.
The Canadian Data Safety Monitoring Board had stopped a Trasylol trial – known as the BART clinical study – 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. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.
Trasylol was approved in 1993 and since then, several studies have found evidence of dangerous side effects associated with it. 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.
Between 1993 and February 2006, the FDA received 235 reports “that noted death in patients who received Trasylol” to control bleeding during heart-bypass surgery. So far the FDA has been unable to confirm the exact number of deaths for the past 19 months. However, 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.
According to Bayer, once the complete BART dataset is available, the company will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol. At that time the temporary marketing suspension will be reevaluated.