Trasylol: 235 Deaths. Are There More?

Washington, DCWhile the world waits for the results of the now-halted Canadian BART study on the effects of anti-bleeding drug Trasylol, various reports of deaths linked to Trasylol lend new emphasis of the wisdom in taking a considered pause, before Trasylol is allowed back on the market.

That last statement is a question mark, as the US Food and Drug Administration (FDA) is on record as saying it is the FDA's intent to work with Trasylol manufacturer, Bayer A.G., in the gradual phasing-out of Trasylol.

Trasylol, known generically as aprotinin, is used to reduce perioperative blood loss during cardiac surgery with cardiopulmonary bypass. Prior studies have raised alarm bells in the past, but it appears the recent Canadian BART study will serve as litmus test that governs Trasylol's ultimate fate.

That study, based in Ottawa, compared Trasylol patients with other controls taking two other antifibrinolyitc drugs.

While the Trasylol patients appeared to experience fewer serious bleeding events, they also appear to have a greater risk of death when compared with study participants taking either of the other two control drugs.

The BART study was, in fact, halted when the death rate amongst Trasylol patients climbed to an alarming level.

Trasylol was pulled from the market in Canada, the US and Germany soon after the BART study was halted, and worldwide marketing has been halted pending further analysis of the BART data up to, and including the point at which the study was halted.

Meanwhile, reports suggest that the FDA has documented 235 deaths linked to Trasylol. According to an FDA spokesperson those deaths cover the period between 1993, the year Trasylol was approved and first introduced to the market, and February 2006. While there is no conclusive evidence that Trasylol was actually, and solely responsible for those deaths, there is reason to believe a link is present.

The New York Post recently reported the case of a Long Island man and Trasylol patient who died in 2006 after an eight-month stay in hospital during which his legs were amputated and he required kidney dialysis. Joseph Randone, a 52-year-old travel agent and father, died in August of that year.

The BART clinical study suggested that Trasylol raised the risk of death by 50 per cent, when compared with other drugs.

It would appear that the FDA would like to see Trasylol phased out altogether, although it has stated that it will only do so on a gradual basis, and only in such a way that it would not create hardships for doctors and their patients. While there are alternatives, it appears that the agency would like to verify that fact—as well as continue to make Trasylol available for doctors and surgeons to use, on a patient-by-patient basis, where warranted.

Since 1993, it has been reported that Trasylol has been administered to 4.8 million people prone to blood loss during surgery. Unless they were specifically told by their surgeon, or unless they had access to their surgical records, most patients would be unaware that they were administered a Trasylol injection. Thus, there is a possibility that any health issue, or death resulting from kidney failure, heart attack, or stroke following heart bypass surgery, could very well be linked with Trasylol.

The FDA has had Trasylol under surveillance for two years, since a 2006 report in the New England Journal of Medicine suggested that Trasylol side effects could lead to higher incidence of heart attack, heart failure and stroke. That was in January of the year. By December, the FDA had issued a black box warning for Trasylol.

A year later, it was recommending that it be pulled from the market. Given the agency's usual caution, and reluctance to call in a drug after it has been approved and actively marketed, for the FDA to recognize such need for action is telling.