Trasylol Pulled From Worldwide Market(nary artery bypass surgery at 62 medical...),Health

The five-year death rate for patients given Trasylol was 20.8 percent, compared to 15.8 percent for those given another drug, aminocaproic acid, and 14.7 percent for those given tranexamic acid. Both alternative drugs are available in generic versions.

After the 2006 report from Mangano's group, the FDA advised doctors to carefully monitor Trasylol patients for kidney, heart and brain damage -- an action taken after Bayer disclosed study data showing that it increased the risk of death, kidney damage, congestive heart failure and stroke.

The drug does have its defenders.

Dr. T. Bruce Ferguson Jr., associate director of cardiothoracic and vascular surgery at East Carolina University, wrote an accompanying editorial to the JAMA study. He said he believed the study "was inadequate to address the question they were asking because of the way the database was designed."

"The most important factor they were unable to control was why patients got aprotinin," Ferguson said. "There were no data to address that issue, and therefore it cannot account for physician-related bias."

For example, the higher rate of death and other complications linked to the drug might be due to aprotinin being prescribed for "higher-risk patients who could be expected to have a worse outcome and higher mortality," Ferguson said. Other studies have shown that "in carefully selected patients, aprotinin is a good drug," he said.

The information used in the study was thorough and complete, Mangano countered. "In terms of the database, we had between 7,000 and 10,000 pieces of data per patient from 59 centers in 16 countries, including 23 of the 25 top cardiac centers in the United States," he said.

"The findings speak for themselves," Mangano added. "I thin
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