Tuesday, November 07, 2006

Trasylol (Heart Surgery) News: Link To Kidney Failure

Trasylol (Generic: Aprotinin) is produced by Bayer. It is an injectable drug used to prevent excessive blood loss during heart surgery.

According to reports the drug doubles the risk of kidney failure and stroke and increases the risk of heart failure or heart attack by 55%. It is also linked with encephalopathy (degenerative brain diseases). Researchers announced their findings earlier this year, and the study results were published in the New England Journal of Medicine.

In late September of this year, the FDA held a public advisory committee meeting on to address the safety profile for Trasylol.

Also in September, Bayer informed the FDA that it had completed a study on this drug. The early findings from this study of patients from a hospital database reported that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.

October was not kind to Bayer and Trasylol. In October, Bayer suspended two senior employees over the company's failure to provide U.S. regulators with data on its heart-surgery drug Trasylol. Bayer also said it had hired an independent counsel to investigate its actions regarding the disclosure of the preliminary results from the Trasylol study. Source here.

FDA officials apparently contacted Bayer about making changes to the label, and also about developing a possible blood test to screen patients for adverse reactions.

Doctors currently are advised to give a small test dose to patients first, but FDA staff have said the tests do not always work and can also be fatal.