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Trasylol Safety Questionned Again

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A new Trasylol (aprotinin) study concludes that less expensive medications are safer than the now-withdrawn Bayer drug.

To reach that conclusion, researchers at the Institute for Clinical Evaluative Sciences (ICES) in Toronto reviewed 49 randomized trials comparing Trasylol to one of two lysine analogues, tranexamic acid or aminocaproic acid. 

“Compared with aprotinin, lysine analogues are almost as effective, are cheaper and do not appear to increase mortality,” the authors concluded after reviewing the randomized trials. “Either tranexamic acid or epsilon aminocaproic acid should be recommended to prevent bleeding after cardiac surgery,” the team wrote.

Trasylol was approved by the US Food & Drug Administration (FDA) in 1993 and, before it was withdrawn,  had been used in  a third of all heart surgery patients in the US. However, Trasylol has been the subject of concern for years, and its safety has been reviewed by the FDA several times.

Last October, the Canadian Data Safety Monitoring Board 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”. Following the revelations over the Canadian Trasylol study, Bayer suspended sales of the drug in the US, Canada and Germany.

Bayer decided to take Trasylol off the market for good after an analysis of the Canadian study  was published this past May in The New England Journal of Medicine.  The analysis  found that of the 2,331 people enrolled in the BART study, the death rate among Trasylol patients was 6 percent, while the rate for those being treated with lysine analogues was 4 percent. That represented an increased death rate of 53 percent for Trasylol patients, which translates to one extra death for  every 50 patients treated with Trasylol.

The latest review, which appears in the Canadian Medical Association Journal,  included new information from the earlier BART study.

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