Expert Testimony on Trasylol
What follows is a sampling of quotes from people knowledgeable about Trasylol and its various symptoms and side effects, and the resultant lawsuits:
“The least that should be done is to inform the patient that the risk of going on dialysis is increased two- to three-fold, and there are alternatives.”
—Dr. Dennis Mangano of the Ischemia Research and Education
Foundation, comparing Trasylol with aminocaproic acid
and tranexamic acid (January 2006)
“I could not administer Trasylol to this group of patients [people undergoing heart surgery], especially given the availability of safer alternatives.”
—Dr. Mangano again
“It just strains credulity that only they would know.”
—Dr. Steven Findlay of the FDA, on Bayer suspending two employees for failing to pass on to the agency the results of a large study showing that patients taking Trasylol were at an increased risk of heart attack, stroke and renal failure
“While some have argued that voluntary clinical trials, registries and databases suffice, the events surrounding Trasylol show why voluntary systems are wholly inadequate.”
—spokesman for Sen. Christopher Todd, co-sponsor of a bill to reform drug safety regulation at the FDA
“I believe there should be consequences for Bayer in withholding this information. If possible, the punishment should be severe enough to provide a deterrent for future such actions.”
—Dr. John R. Teerlink of the University of California, on Bayer not turning over unflattering information about Trasylol to the FDA
“The association between aprotinin [Trasylol] and serious end-organ damage indicates that continued use is not prudent. In contrast, the less expensive generic medications aminocaproic acid and tranexamic acid are safe alternatives.”
—primary conclusion of article published in the New England Journal of Medicine (January 2006)
“Some surgeons and anesthesiologists who use the drug have been concerned about its potential risks since it was first approved. Yet … sufficient data have not been available for an analysis of the risks and benefits of aprotinin.”
—Dr. Gus Vlahakes of Harvard Medical School, in an editorial
that accompanied the article in the NEJM (January 2006)