Safety Alerts
Continuation of the restricted access programme for aprotinin (Trasylol®)
Audiences
Healthcare professional
Industry member
Product type
Therapeutic Products
24 August 2012
This article has been migrated from an earlier version of the site and may display formatting inconsistencies.
The Health Sciences Authority (HSA) would like to update healthcare professionals on its decision to retain the restricted access programme for aprotinin (Trasylol®, Bayer Pte Ltd). This follows a comprehensive benefit-risk assessment of the available data from the final analysis of the Canadian Blood conservation using Antifibrinolytics in a Randomised Trial (BART), literature studies as well as international regulatory actions. This regulatory decision has been made in consultation with its Product Vigilance Advisory Committee (PVAC).
Regulatory history for Trasylol®
Trasylol® has been licensed locally since July 1994 for the prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at increased risk for blood loss and blood transfusion.
In November 2007, the sale of Trasylol® was suspended worldwide in response to the results from an interim analysis of the BART study, suggesting that Trasylol® was associated with an increased risk of mortality when used in high risk cardiac surgeries as compared to lysine analogues, namely tranexamic acid and aminocaproic acid. Since then, Trasylol® has been made available locally via the restricted access programme.1 Under this restricted access programme, doctors are required to provide a written undertaking that they have understood the risks associated with the use of Trasylol®, will discuss the risks involved with patients and obtain their written consent before prescribing Trasylol®.
HSA's benefit-risk assessment
HSA has completed its benefit-risk assessment which, besides the final analysis of the BART study and data from scientific literature, also took into consideration the local experience of the Trasylol® restricted access programme as well as advice from its PVAC. The outcome of the review concluded that Trasylol® continues to have a place in therapy in preventing blood loss in patients undergoing cardiopulmonary bypass who are at increased risk for blood loss and blood transfusion.
HSA's regulatory decision
HSA has assessed that the aprotinin restricted access programme has served its purpose of ensuring the safe use of Trasylol® locally and will be continued.