Trasylol (aprotinin) – Worldwide Temporary Suspension of Marketing

Notice type: Advisory

Date: 07/11/2007


Product name or type:

Dear Healthcare Professional Communication – November 2007

Authorisation Number:
Unauthorised for use in Ireland

Active Substance:

Product Classification:
Antithrombotic Agents

Target Audience:
Patients & Healthcare Professionals

Problem Or Issue:
Worldwide marketing of Trasylol® (aprotinin injection) has been temporarily suspended pending evaluation of the final results from the Canadian BART study. Trasylol is not authorised for use in Ireland, however, as there has been some use of it in the context of its approved indications elsewhere, the IMB considered it important to highlight this information among healthcare professionals.   

This action follows consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities, pending compilation and evaluation of final results from the Canadian BART study and the impact of these data on the overall  benefit-risk assessment for Trasylol.    

The BART study is an independent randomized, controlled trial conducted in high-risk cardiac surgery patients, which was the subject of a separate communication in Ireland last week.  The study was discontinued following review by the Data Safety Monitoring Board (DSMB) responsible for the assessment of safety data from the study after a regular interim analysis which showed a decrease in the occurrence of bleeding but also an increase in overall mortality in the Trasylol®-arm as compared to two other drugs (tranexamic acid and aminocaproic acid). For the 30-day-mortality this borders on statistical significance. The increase in relative risk was 1.5 for the Trasylol®-arm compared to drug B (p-value 0.06) and drug C (p-value 0.08) in the comparator groups.   

When more complete information is available from the BART study and has been assessed by the company and regulatory authorities, further communications will be issued  regarding any further actions that may be undertaken in response to the analysis of that information.   

Until these issues are resolved Bayer has temporarily suspended marketing of Trasylol and halted all shipments on a world-wide basis.   Information concerning the temporary marketing suspension has been communicated by the company to healthcare professionals in Ireland.

Background Information Or Related Documents:
Trasylol (aprotinin) – Worldwide Temporary Suspension of Marketing Document

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