FDA to Review Clotting Drug After Trial Suggests Death Risk

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. National Library of Medicine.