Evaluation of reports of suspected adverse drug reactions in transplant patients of a sentinel hospital in Fortaleza-Ceará
Keywords:
Farmacovigilância, Sistemas de Notificação de Reações Adversas a Medicamentos, TransplanteAbstract
The study aimed to describe and analyze reports of suspected Adverse Drug Reactions (ADRs) at the transplant service of a sentinel hospital in Fortaleza, Ceará. A descriptive, cross-sectional, observational study was performed using, as a secondary source, notification forms of suspected ADRs of risk management in 2014. There were 35 reports involving transplanted patients, 52 drugs and 50 reactions in the hospital. All notifications were made spontaneously, being 94.5% reported by a pharmacist. The most affected patient age groups were 50-60 years and > 60, with an average age of 51.79 (± 14.09) years. Adverse reactions affected mainly men (55%), kidney transplant patients (69.69%). The major drugs involved were ganciclovir (21.2%), tacrolimus (13.5%) and sodium mycophenolate (11.5%). Most ADRs were related to skin diseases and related disorders (23%), 77% pruritus and 23% erythema. Analyzing the causality classification of ADRs, 46% were classified as possible and 88% were classified, regarding severity, as moderate. The findings indicate that the suspicions of reactions notified in transplant patients were associated with the pharmacotherapy commonly established during post-transplantation, leading to the need for monitoring.
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