As if patients facing heart bypass surgery did not already have enough to worry about, there is now a chance that Trasylol, a drug used to prevent blood loss, might actually increase their risk of kidney problems, heart attacks, and strokes. Patients who suffered serious injuries as a result of Trasylol are now filing lawsuits against the drug’s maker, alleging it knew about the risks but failed to warn patients.
The first lawsuits against Bayer, maker of Trasylol, were filed earlier this year.
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.
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.
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.
If you have suffered kidney failure, heart problems, or other permanent complications after surgery, please contact us at ggreen@gGreen.com.