Continuation of the restricted access programme for aprotinin (Trasylol®)

HSA updates healthcare professionals on its decision to continue the restricted access programme for Trasylol^®following comprehensive benefit-risk assessment of data from Canadian BART study, literature studies and international regulatory actions. Trasylol^® has been made available under the restricted access programme since November 2007 in response to worldwide suspension of Trasylol^® following an increased risk of mortality observed from an interim analysis of the BART study. The outcome of HSA's 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 transfusion. HSA has assessed that the existing aprotinin restricted access programme has served its purpose of ensuring the safe use of Trasylol^® locally and should be continued. Trasylol^® should continue to be used in accordance with its approved indication after the physician has assessed the benefits and risks of the treatment carefully and considered other alternatives. Please refer to the letter for more information.