Pharmacoepidemiology of Tacrolimus in Pediatric Liver Transplantation.

Abstract

The aim of this study was to implement an intensive pharmacovigilance program of Tacrolimus (FK) in pediatric liver transplant patients at Hospital de Pediatria JP Garrahan, Buenos Aires, Argentina. Control of adverse events resulting from the post transplant immunosuppressive therapy is essential to promote both patient compliance and their overall survival. Despite pharmaco-therapeutic and surgical advances, complications and adverse events occur, increasing morbid- mortality in these patients. FK is a critical dose drug thus close therapeutic drug monitoring and vigilance of adverse events are recommended. We retrospectively evaluated patients that underwent liver transplant between 2010 and 2011 (n=59), through review of medical records and physician consultations. We followed up the cohort of patients prospectively for 2 years. Adverse drug reactions (ADRs) were reported to the national health authority, classified by causality using the Naranjo algorithm, and according to severity. Fifty seven out of 59 liver transplant patients were analyzed based on the accessibility of clinical records. A total of 68 ADRs were reported, standing hypomagnesemia (59%), post transplant lymphoproliferative disease (6%), hypertension (6%) and nephrotoxicity (16%). The rate of Epstein Barr Virus infection was 70%. A total of 98% of ADRs was moderate or severe and 96% of ADRs have been grouped as probable or definitive. A total of 39% of patients present one o more episodes of Biopsy Proven Acute Rejection in the first year post transplant and 72% of the study group received induction therapy with basiliximab. The present is the first project reported in Latin America that aims to evaluating and reporting safety and efficacy of FK in pediatric liver transplant patients. It is important to continue the study since the results may help to show safety and efficacy profiles that have not been described so far.