The FDA has issued interim recommendations for using Trasylol (aprotinin injection) until a study determines if the drug increases the likelihood of death, serious kidney damage, congestive heart failure, and strokes.
On September 27, Bayer told FDA that preliminary findings from a new study of Trasylol suggested that greater risks of complications may exist compared with use of an alternative drug to decrease bleeding.
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Until FDA completes its evaluation, it is advising healthcare providers to monitor patients carefully for toxicity and consider limiting Trasylol use to circumstances in which reduced blood loss is essential and outweighs the potential risks.
