Safety aspects of aprotinin therapy in cardiac surgery patients.
Aprotinin is the only agent with Class A Level 1 evidence for reduction in rates of transfusion and return to operating theatre to control bleeding after heart surgery. Principal on the list of safety issues raised over the years are increased risk for: a) thrombosis; and b) renal dysfunction. With multiple administrations, hypersensitivity reactions have emerged as a further safety concern. This review discusses these issues, based on the examination of > 500 published articles. The article also specifically places in context the data presented recently from the observational McSPI database analysis. This report suggested that aprotinin should be withdrawn from human use as serious safety issues have been ignored or missed, an inference not in agreement with the majority of the human safety literature.
Royston
David
D
Royal Brompton and Harefield NHS Trust, Department of Cardiothoracic Anaesthesia and Critical Care, Harefield Hospital, Hill End Road, Harefield, Middlesex, UB9 6JH, UK. dave@tharg.demon.co.uk
Chhatwani
Asha
A
D007611:Aprotinin / Q000009:adverse effects*; D006348:Cardiac Surgical Procedures; D003627:Data Interpretation, Statistical; D004342:Drug Hypersensitivity / Q000209:etiology*; D006488:Hemostasis, Surgical / Q000379:methods; D006490:Hemostatics / Q000009:adverse effects*; D006801:Humans; D019106:Postoperative Hemorrhage / Q000517:prevention & control; D051437:Renal Insufficiency / Q000209:etiology*; D012107:Research Design; D013927:Thrombosis / Q000209:etiology*
D006490:Hemostatics; D007611:Aprotinin