Study May Seal Fate of Heart Surgery Drug

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May 16th, 2008

"Trasylol Linked to Risk of Death"

A rigorous study involving the heart surgery drug Trasylol is likely to seal the drug’s fate, as researchers are left with little doubt of the greater likelihood of death in patients given the anti-bleeding medication.

Linked to Risk of Death

Trasylol (aprotinin) has been used to control bleeding in heart surgery patients since 1993 when it first gained FDA approval. In 2006, serious questions were raised about the drug’s safety when a study linked Trasylol to an increased risk of death, stroke, heart attack and kidney failure.

Additional studies have since linked Trasylol to a heightened risk of death, and experts say that studies that didn’t see an elevated risk of death had numerous weaknesses.

Study Halted over Risk

The latest study to confirm this risk was the first to compare Trasylol directly to two similar, less costly drugs used by surgeons to prevent serious blood loss during cardiac surgery.

According to the study findings, patients who received Trasylol faced a 54 percent greater chance of death than patients given either of the two other drugs. The study was stopped early when researchers noted the higher risk of death in Trasylol patients.

“There was no way we could ethically enroll (more patients) in the trial because we had our answer. I think the results are quite definitive…” said Dean A. Fergusson, lead researcher of the Canadian study.

Off the Market for Good?

Shortly after the study was halted, Bayer AG temporarily pulled Trasylol from the market. Experts are now saying that the drug will likely remain that way, though Bayer said it has not yet decided what it will do.

However, two experts from the Vanderbilt University School of Medicine said that “in all likelihood, this is the end of the aprotinin story.”

Bayer is currently facing more than 80 Trasylol lawsuits.

(Source: Associated Press)

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