The first lawsuits against Bayer, maker of Trasylol, were filed earlier this year. On January 25, 2007 a lawsuit was filed on behalf of Ada Williams who was given Trasylol and suffered kidney failure. She now requires kidney dialysis three times a week. The lawsuit seeks damages for pain and suffering and medical costs.
A study published in the New England Journal of Medicine, (January 26, 2007) found that Trasylol had an increased risk of kidney failure, stroke, and degenerative brain disease. The study concluded, "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."The study found the increased risks of serious injury were significant. Trasylol was found to have a 55 percent increased risk of heart failure and a 181 percent increased risk of stroke or encephalopathy (degenerative brain disease). The research team estimated that up to 10,000 patients now require dialysis because of Trasylol.
Dennis Mangano of the Ischemia Research and Education Foundation, and lead author of the study, said that the decision to withdraw Trasylol from the market is a regulatory matter, but he noted that serious side effects occurred more frequently in Trasylol than they did in Vioxx, which was taken off the market after being linked to an increased risk of heart attack and stroke. "In good conscience, I could not administer [Trasylol] to this group of patients, especially given the availability of safer alternative," Mangano told United Press International.
Furthermore, a study published in the Journal of the American Medical Association found Trasylol was associated with a 48 percent increased risk of dying within five years of coronary artery bypass surgery. In fact researchers noted, as reported in The New York Times, that replacing Trasylol with other drugs for a year would prevent 10,000 deaths worldwide over the next five years.
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Questions have been raised about what Bayer knew about the risks of Trasylol and when officials knew it. Allegations of withholding information from the U.S. Food and Drug Administration (FDA) have been made, although it is not clear whether the omission was intentional or erroneous. Despite a safety meeting with FDA officials, Bayer representatives failed to mention that their company had undertaken a safety study of Trasylol. Preliminary findings of that study found an increased risk of death, kidney damage, stroke, and congestive heart failure. Yet Bayer did not inform the FDA of this data at the safety meeting.
The FDA only learned of the study after a whistleblower tipped the agency off. The whistleblower is believed to be a researcher involved in Bayer's study.