Bayer Yanks Aprotinin off the Market Pending Analysis of BART

from Heartwire — a professional news service of WebMD

Shelley Wood


November 05, 2007

November 5, 2007 (Leverkusen, Germany and West Haven, CT) - Aprotinin (Trasylol) manufacturer Bayer has suspended worldwide marketing of the drug, pending final results from the Canadian Blood Conservation Using Antifibrinolytics Trial (BART). As reported by heart wire , enrollment in BART, a high-risk cardiac surgery trial, was halted in mid-October after more patients receiving aprotinin died within the first 30 days of the trial, as compared with patients taking epsilon-aminocaproic acid or tranexamic acid. A company press release notes that while bleeding rates were reduced in the aprotinin arm of the trial--the hypothesized benefit of the drug in this study--mortality "almost reached conventional statistical significance," which was enough for the data and safety monitoring board to suggest the trial be stopped.

The company made the decision to yank aprotinin after consulting with the German Federal Institute for Drugs and Medical Devices (BfArM), the FDA, Health Canada, and other health authorities, a Bayer press release states.

Aprotinin is currently approved for preventing perioperative blood loss and cutting the need for transfusions during pump-supported CABG surgery in high-risk patients. But it has faced a rocky ride since a phase 4 study came out in early 2006 indicating that despite 13 years on the market, the drug appeared to increase the risk of serious end-organ damage, particularly renal failure. The FDA subsequently issued a public-health advisory alerting doctors to the higher risk of renal failure, MI, and stroke. Later last year, an FDA advisory panel ruled that aprotinin was safe if used as indicated, only to learn of additional data that might have swayed its decision. Meeting again a year later, the FDA panel once more recommended that aprotinin stay on the market with stronger warnings, and just last month, a large meta-analysis of randomized trials indicated that aprotinin does not raise the risk of operative thrombosis or death.

But BART, again, seemed to be heading in the wrong direction. At the time the trial was stopped, the FDA announced: "In light of the preliminary BART study findings, the FDA anticipates reevaluation of the overall risks and benefits of Trasylol. This reevaluation may result in the need to revise the labeling or other regulatory actions."

For now, Bayer is calling the marketing suspension "temporary" and says it is in the process of collecting data from centers across Canada. It intends to perform a full data analysis before making a final decision on the drug--a process that will take eight weeks or longer, the press release notes.

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