FDA to Review Clotting Drug After Trial Suggests Death Risk

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"Our present findings deal with death," one of the JAMA study's authors, Dr. Dennis T. Mangano, said at the time. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, said that "the death rate for aprotinin patients far outstrips that for the other two drugs."

His team's study tracked the long-term survival of nearly 3,900 heart patients who underwent coronary artery bypass surgery at 62 medical centers worldwide. The researchers tabulated survival at six weeks, six months, and then annually for five years.

The five-year death rate for patients given aprotinin 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 aprotinin 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 2006 report led to a 37 percent reduction in surgeons' use of aprotinin, Mangano said. "Clinicians, more than anyone else, will decide whether this drug should be on the market or its use should be limited," he said.

Aprotinin 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 believes 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.