Eventos adversos con tacrolimus en el Programa Distrital de Farmacovigilancia Bogotá D.C. 2012 - 2015
Sánchez Castillo, Julián | 2017
Introduction: Currently, there is an increase in the number of people that require an organ transplant, and to avoid rejection of the transplanted organ patients require the administration of drugs such as tacrolimus. However, in the case of these medicines it is necessary to extend the safety profile through the pharmacovigilance programs. Objective: To analyze and characterize the adverse events associated with the use of tacrolimus obtained through passive pharmacovigilance by the Pharmacovigilance’s District Program, Bogotá D.C from 2012 to 2015. Methods: An analysis with the WHO’s algorithm for adverse reactions, a test of the Center of Information in Drugs of the National University of Colombia (CIMUNC by its acronym in Spanish) for therapeutic failure and the Third Consensus of Granada for problems related to tacrolimus were performed. Results: 50 events were reported, of which all correspond to adverse reactions to tacrolimus. 78 % of the adverse events with tacrolimus occurred in the male gender. 59 % of the events associated with the use of tacrolimus correspond to serious reactions, of which 24 % required hospitalization. 54 % of the reports of adverse events related with tacrolimus correspond to the year 2015. In 60 % (30) of the reports there are other causes associated with the adverse event, but the association of the event with the use of the medication is not ruled out. Adverse reactions include polio, nephrotoxicity, urinary tract infections, pneumonia and arrhythmias. In 3 reports there are potential interactions with clarithromycin, omeprazole, lovastatin, mycophenolate mofetil and prednisolone. Kidney transplantation was the main indication in 72 % of the reports. Conclusions: In real conditions of use, adverse reactions to tacrolimus are present which through a greater knowledge of comorbidities or risk factors of the patient are potentially avoidable.