Objetivos. Caracterizar los eventos adversos (EA) asociados a hidroxicloroquina (HQ), azitromicina (AZI), tocilizu-mab (TOB) e ivermectina (IVM) prescritos como «fuera de etiqueta» en el tratamiento de pacientes hospitalizados por la COVID-19. Materiales y métodos. Se realizó unanálisis secundario transversal de la base de datos del sistema de farmacovigilancia del Seguro Social de Salud del Perú (EsSalud) de las notificaciones de EA a HQ, AZI, TOB e IVM provenientes del Hospital Nacional Edgardo Rebagliati Martins de abril a octubre del 2020. Se revisaron las historias clínicas digitales, se estimaron las tasas de reporte de EA y se evaluaron sus características por tipo de fármaco, tiempo de aparición, tipo por órgano-sistema afectado, gravedad y causalidad. Resultados. Se identificaron 154 notificaciones que describen un total de 183 EA posiblemente relacionados con HQ, AZI...

Introducción: El ductus arterioso persistente (DAP) es una cardiopatía congénita de especial interés. La oclusión intervencionista es el tratamiento de elección, no obstante, el dispositivo médico “oclusor para DAP”, usado en este procedimiento, puede dar lugar a la aparición de eventos adversos de rara frecuencia como hemorragia, trombocitopenia, entre otros. Reporte de caso: Se presenta un caso de una paciente pediátrica con trombocitopenia severa posterior a la intervención. Durante su hospitalización, la paciente mantuvo niveles bajos de plaquetas hasta que logra su recuperación y sale de alta sin una nueva manifestación hematológica. El caso fue reportado como sospecha de incidente adverso asociada al oclusor para DAP. Conclusión: Al realizarse el análisis causa-raíz, se concluye que el tamaño del oclusor para DAP podría ser la principal causa de la trombocito...

Introduction: Patent ductus arteriosus (PDA) is a congenital heart condition of special interest. Interventional occlusion is the treatment of choice; however, a PDA occlude, used in this procedure, is a medical device that rarely could lead to adverse events such as hemorrhage, thrombocytopenia, etc. Case report: We present a case of a pediatric patient with severe thrombocytopenia after surgery. During her hospitalization, platelet levels remained lower and, finally, she was fully recovered without any hematological manifestation. The case was reported as a suspected adverse incident related to PDA occlude. Conclusion: After performing a cause-root analysis, we concluded that the size of the PDA occlude may be the main cause of thrombocytopenia.  This case demonstrates that medical devices could lead to adverse events. Thus, it is important for clinicians to implement medical device s...

Irreversible cardiotoxicity (IC) induced by trastuzumab (TZB) is a rare but serious adverse event. As a result, its characteristics and the specific factors related to exposure remain poorly understood. This study aims to synthesize and evaluate the existing evidence on IC. We presented a pharmacovigilance case of longterm IC and conducted a systematic review (SR) of the clinical manifestations of cases reported worldwide. We reported the case using the CARE guidelines checklist and assessed the causality using the modified Algorithm of Karch and Lasagna. Following PRISMA guidelines, we conducted the SR using defined terms in PubMed, Embase, Scopus, and Web of Science from inception until June 2023. This SR included five case reports, including the pharmacovigilance case reported by us. While patients exhibited different severe clinical characteristics, receiving TZB at a 6 mg/kg dose wa...

Irreversible cardiotoxicity (IC) induced by trastuzumab (TZB) is a rare but serious adverse event. As a result, its characteristics and the specific factors related to exposure remain poorly understood. This study aims to synthesize and evaluate the existing evidence on IC. We presented a pharmacovigilance case of longterm IC and conducted a systematic review (SR) of the clinical manifestations of cases reported worldwide. We reported the case using the CARE guidelines checklist and assessed the causality using the modified Algorithm of Karch and Lasagna. Following PRISMA guidelines, we conducted the SR using defined terms in PubMed, Embase, Scopus, and Web of Science from inception until June 2023. This SR included five case reports, including the pharmacovigilance case reported by us. While patients exhibited different severe clinical characteristics, receiving TZB at a 6 mg/kg dose wa...