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Danger From Heart Surgery Drug Confirmed
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Page: << Prev | 1 | 2 | 3 | Next >> Most of the deaths associated with Trasylol were from cardiac complications, Hebert said. Because of the significant increased risk of death, the trial was stopped in October 2007, before the scheduled completion date.
The researchers concluded that while Trasylol may have a small advantage in reducing massive bleeding, the increased risk of death precluded the use of the drug in patients undergoing high-risk heart surgery. "That's the statement at the end of the paper, and we stick by it," Hebert said.
However, despite the drug being pulled off the market in many countries, Bayer continues to sell Trasylol in some areas of the world.
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"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.
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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 5/14/2008
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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, online New England Journal of Medicine
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