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Trasylol

If you have undergone CBAG surgery in the past and believe you have been injured by Trasylol, you may be entitled to recover damages for your injury.

The January 25, 2006 issue of the New England Journal of Medicine reported on a study that revealed that Trasylol 4,374 coronary bypass artery graft patients suffered twice the risk of renal failure and stroke and also a 55% increase in occurrences of heart failure or heart attack. Furthermore, despite the arrival of several low cost generic drugs that are more effective and less dangerous, many doctors still continue to use Trasylol in CAGB procedures.

On September 29, 2006 the FDA announced it held a public advisory committee meeting on 9/21/06 to discuss the safety and overall risk-benefit profile for Trasylol. The committee reviewed the findings from the two published observational studies, the Bayer worldwide safety review, and the FDA review of its own post-marketing database.

On 9/27/06, Bayer informed the FDA that it had carried out an additional safety study of Trasylol. The preliminary findings from this new observational study of patients from a hospital database reported that use of Trasylol might increase the chance for death, serious kidney damage, congestive heart failure and strokes.

While the FDA conducts its assessment of this new safety study, it is recommended that physicians consider limiting Trasylol use to those situations where the clinical benefit of reduced blood loss is essential to medical management and outweighs the potential risks. Doctors should carefully observe patients for the occurrence of toxicity, particularly to the kidneys, heart, or brain.

Trasylol (Generic: Aprotinin), Bayer's injectable drug used to prevent excessive blood loss during heart surgery, 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).

Bayer Disputes Findings

Bayer responded to the findings, claiming that the data were not in line with the 15 years of clinical data the company has collected. But the study's chief author, Dennis Mangano of the Ischemia Research and Education Foundation, said the results are clear and that with safer and less expensive alternatives available, Trasylol use is not prudent. Bayer has been hoping that Trasylol would be used in all types of surgeries.

Legal Help for Trasylol Victims

If you or a family member experienced kidney failure, heart attack, heart failure, stroke, encephalopathy or other side effects as a result of Trasylol used in surgery, call us at (800) 220-LAW1, or use the "Do I Have A Case?" link on this web site.

This informational piece was prepared by Silverman & Fodera. If you would like more information on this topic, call us at (800) 220-LAW1, or use the "Do I Have A Case?" link on this web site.