Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction

A national, prospective and spontaneous reporting-based pharmacovigilance program was conducted in Cuba. Patient demographics, suspected ADR description, elements to define causality, and outcomes were documented and analyzed.A total of 1496 suspected ADRs identified in 792 patients out of the 1660 (47.7 %) prescriptions reported in the program, were received from July 1995 to July 2002. Most of the patients (71.3%) were male, 67.2% were white and mean age was 61.6 ± 13.0 years. The mean time interval between the onset of symptoms and the start of the SK infusion was 4.9 ± 3.7 h. The most frequently reported ADRs were hypotension, arrhythmias, chills, tremors, vomiting, nauseas, allergy, bleeding and fever. ADR severity was 38% mild, 38% moderate, 10% severe, and 4% very severe. Only 3 patients with hemorrhagic stroke were reported. Seventy-two patients died in-hospital mainly because of cardiac causes associated with the patient's underlying clinical condition. Mortality was 3 times more likely in patients suffering arrhythmias than in those without this event (odds ratio 3.1, 95% CI: 1.8 to 5.1). Most of the reported ADRs were classified as possibly or probably associated with the study medication.Recombinant SK was associated with a similar post-marketing safety profile to those suggested in previous clinical trials.Streptokinase (SK) is an indirect fibrinolytic agent that interacts with plasminogen, forming an active complex with protease activity that converts plasminogen to plasmin [1]. SK efficacy with regard to mortality reduction in patients with acute myocardial infarction (AMI) has been demonstrated in large, placebo-controlled trials [2,3].A SK produced by recombinant DNA techniques (rSK) has been evaluated previously in clinical trials in AMI patients. The first studies suggested that rSK produced the same benefits that were described for natural SK [4,5]. These results were further supported by the Thrombolysis with Recombinant Streptokinase in Acute M