Danger From Heart Surgery Drug Confirmed

"Trasylol, currently under temporary market suspension worldwide, continues to be available in some countries under special access programs as reviewed and agreed to with the relevant regulatory bodies in those markets," said Bayer spokeswoman Staci Gouveia.

Gouveia noted that Bayer is continuing to keep its options open as to whether it will try to reintroduce the drug.

"Bayer will continue to carefully review this article, the editorial and [when available] the underlying data on which the authors have based their conclusions and continue to discuss both the restricted access programs for Trasylol and the worldwide temporary marketing suspension of the drug with regulatory authorities," Gouveia said.

But one expert thinks the results of this trial end the use of Trasylol during cardiac surgery.

"For all practical purposes, unless there is surprising new data, the BART findings preclude future use of aprotinin in cardiac surgery, even though we don't fully understand why the increased risk of death occurs," said Wayne A. Ray, director of the Division of Pharmacoepidemiology at Vanderbilt University School of Medicine and author of an accompanying journal editorial.

Ray noted that the results of this trial were different from those of other trials, which found no increased risk of death.

"However, this was because the earlier trials were mostly small and not designed to study death," Ray said. "Future studies of drugs to prevent blood loss in cardiac surgery must be designed to look at death and other important clinical consequences, rather than only focusing on blood loss."

Another expert thinks the study starkly shows the dangers of Trasylol.

"This is yet another striking demonstration of the risk of aprotinin," said Dr. Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine.

Trasylol had been on the market since 1987 and was widely used.

The big questions remaining are "why it takes so long for the truth to come out? And how many patients were lost because of this misadventure in therapeutics?" Topol said.

Topol thinks there is enough blame to go around. "Did the clinical community accept it too readily? Was the manufacturer not willing to do the appropriate trials?" he asked.

The U.S. Food and Drug Administration is also very high on the blame list, Topol said. "The FDA has to be considered part of the problem," he said. "Why weren't trials like this part of the early approval process, rather than getting the data many years later?"

More information

For more on heart bypass surgery, visit the U.S. National Library of Medicine.

SOURCES: May 12, 2008, teleconference with Dean A. Fergusson, University of Ottawa Centre for Transfusion Research, Canada; Paul C. Hebert, M.D., critical care physician, Ottawa Hospital, Canada; Wayne A. Ray, Ph.D., director, Division of Pharmacoepidemiology, and professor, preventive medicine, Vanderbilt University School of Medicine, Nashville, Tenn.; Eric J. Topol, M.D., director, Scripps Translational Science Institute, and dean, Scripps School of Medicine, La Jolla, Calif.; Staci Gouveia, spokeswoman, Bayer HealthCare, Tarrytown, N.Y.; May 14, 2008, news release, U.S. Food and Drug Administration; May 13, 2008, onlineNew England Journal of Medicine