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FDA to Review Clotting Drug After Trial Suggests Death Risk
Date:10/25/2007

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."

"The findings speak for themselves," Mangano said. "I think they are as accurate as you can get."

He believes that aprotinin's use should be restricted to about 5 percent of patients in whom other drugs could not be used.

"And the surgeon would have to tell each patient before using this drug that there is literature out there showing that this drug is associated with renal [kidney] failure and death," Mangano said. "For the vast majority of patients, there are the two other alternatives."

More information

THere's more on cardiac surgery at the U.S> MNational Library of Medicine.

There's more on cardiac surgery at the U.S. National Library of Medicine. ?



SOURCES: Oct. 25, news releases, Bayer, U.S. Food and Drug Adminstration; Dennis T. Mangano, M.D., Ph.D, director, Ischemia Research and Education Foundation, San Bruno, Calif.; T. Bruce Ferguson Jr., M.D., assoc
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