Trasylol (aprotinin) Trial Stopped Due to Adverse Effects

-MedHeadlines

10/27/2007 - The Food and Drug Administration (FDA) has issued a statement informing that the antifibrinolytic drug, Trasylol (aprotinin), appears to increase the risk of death. 

   While the FDA is reviewing the risks and benefits of the medication, which may lead to changes of the drug label, it is recommending that physicians analyze the potential risks and benefits of Trasylol and discuss them with their patients.

   The FDA was informed that the Blood conservation using antifibrinolytics: A randomized trial in a cardiac surgery population (BART) study was halted due to increased risk of death associated with the use of Trasylol.

   The BART study was initially developed to analyze aprotinin's effectiveness in preventing excessive post-cardiac surgery bleeding, as compared to other antifibrinolytics, such as, epsilon-aminocaproic acid and tranexamic acid.

   The FDA statement also informs that:

• 30- day mortality in aprotinin group has almost reached statistical significance at the interim analysis, when compared to either epsilon-aminocaproic acid or tranexamic acid
• increased mortality in the aprotinin group had been observed throughout the study
• aprotinin was associated with fewer cases of serious bleeding than either of the comparator drugs; however, more deaths due to hemorrhage had been observed among patients receiving aprotinin
• Data Safety Monitoring Board officials decided that continual patient enrollment in the study is unlikely to have any impact on the final results

Ennis & Ennis, P.A. is representing individuals that have been harmed as a result of Trasylol side effects. If you or a loved one have suffered as a result of Trasylol side effects such as kidney failure, heart attack, or stroke you may be entitled to compensation. For more information about a Trasylol lawsuit, a possible Trasylol recall, or for questions regarding Trasylol class action lawsuits click here for a free, confidential case evaluation.