Trasylol
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Trasylol
Trasylol was recalled by the FDA on November 5, 2007. Trasylol has been linked to increased risk of death, kidney or renal failure, heart attacks, strokes and encephalopathy among heart surgery patients. If you or a family member has died or suffered injury due to Trasylol you may have a case.
Trasylol is the brand name given by Bayer Corporation to aprotinin, a drug that has been widely used during complex surgeries – especially heart surgery - to control bleeding. It has been widely used for heart patients; estimates are that since its release in 1993, Trasylol use has risen to about 25% of the 1 million heart bypass operations performed annually in this country.
Initial evidence suggested that Trasylol significantly reduced bleeding during surgeries in which it was used, reducing hospital stays as well as mortality rates, as well as reducing the need for transfusions during complex surgeries. In 2006, however, the FDA was made aware of a study that Bayer had conducted a study of 67,000 post-operative patients, including 30,000 who had received Trasylol. The study concluded that patients who were recipients of the drug were at higher risk of cardiac damage, acute renal failure and strokes. Bayer had failed to notify the FDA of its study; the agency learned of its results from one of the researchers.
In October of 2006, the FDA issued a public health warning that Trasylol may create acute kidney and cardiac toxicity. Shortly thereafter, Bayer chose to cooperate by issuing its own warning to physicians of potential risk in use of the drug. In January of 2007, the New England Journal of Medicine published results of a Trasylol study, concluding that risk of heart failure or stroke was 55% higher with the use of the drug than without it. The threat of stroke was even higher for surgical patients who receive Trasylol, compared to those who are treated without it. http://content.nejm.org/cgi/content/abstract/354/4/353
If you or a family member has suffered substantial after effects with kidney or heart problems following surgery that included the use of Trasylol, contact our office and let one of our experts provide a cost-free analysis of your potential for legal compensation.