Heart Surgery Drug Linked to Death Risk

"It's not a perfect study, but the data are compelling enough that we have to use aprotinin judiciously," Sheridan said of the new research.

The study followed 3,876 patients who had heart bypass surgery at 62 medical centers in 16 nations. Researchers compared patients who received aprotinin to patients who got other drugs or no anti-bleeding drugs. Over five years, 20.8 percent of the aprotinin patients died, versus 12.7 percent of the patients who received no anti-bleeding drug.

When researchers adjusted for other factors, they found that patients who got Trasylol ran a 48 percent higher risk of dying in the five years afterward.

The other drugs, both cheaper generics, did not raise the risk of death significantly.

Cost varies depending on dosage and length of surgery, but a two-hour bypass surgery might require $792 in Trasylol, compared with $7 to $35 for one of the generics.

The study was not a randomized trial, meaning that it did not randomly assign patients to get aprotinin or not. In their analysis, the researchers took into account how sick patients were before surgery, but they acknowledged that some factors they did not account for may have contributed to the extra deaths.

Aprotinin joins the painkiller Vioxx, drug-coated stents and other drugs and devices where safety concerns arose after the products were on the market.

"We don't know enough about what happens with drugs and devices once they go into the public domain," said Dr. Bruce Ferguson of East Carolina University, who wrote an editorial accompanying the new study. Drug companies will have to help pay for a better system of post-market safety research because the government can't afford to do it alone, he said.

Similarly, Mangano said: "I would love to see something change as a result of this."

Last week, FDA officials announced plans to assess safety in the first 18 months a drug is on the market.

The earlier study prompted at least two lawsuits against Bayer, including one from 78-year-old Tennessee resident Ada Williams, who was given the drug during heart surgery in 2004.

"She has to live the rest of her life on dialysis three days a week to keep her alive," said her attorney, Craig Niedenthal, one of several lawyers advertising for Trasylol plaintiffs on the Internet.

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