Trasylol is a drug that is intended to prevent blood loss. It is often administered to patients undergoing cardiopulmonary bypass surgery. On February 8, 2006 the FDA issued a Public Health Advisory for Trasylol (aprotinin injection) after two observational studies reported a possible association with the administration of the drug, kidney failure and ischemic events (heart attack and stroke).
A study published by the New England Journal of Medicine concluded that Trasylol was associated with more adverse outcomes, and suggested that patients that received higher doses of Trasylol were at greater risk for adverse events than those that had received lower doses. Patients were not assigned at random, and so investigators used statistical procedures to adjust for known differences in the treatment groups.
A similar study, published by Transfusion (online edition) suggested a possible association with the drug and kidney failure.
The FDA is currently evaluating these and other “studies in literature and reports submitted to the FDA through the MedWatch program, to determine if labeling changes or other actions are warranted.”
Please contact Sheller, Ludwig & Badey at 800-883-2299 if you or one of your relatives was given Trasylol or an Aprotinin Injection and suffered a heart attack, stroke or kidney failure.
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