Safety Study of Heparin Sodium 5000 IU/mL in Geriatric Patients

Abstract

Introduction: In Cuba, in 2018, the reformulation of heparin sodium 5000 IU/mL was carried out as a continuous quality improvement. It is a product with less than five years in the national market, so its safety in routine clinical practice should be evaluated.

Objective: To evaluate the safety of heparin sodium 5000 IU/mL in geriatric patients through spontaneous notifications.

Methods: Observational, descriptive and cross-sectional case series study. The universe included 17 patients aged between 60 and 86 years on average, who were treated with heparin sodium 5000 IU/mL. The type of event, organ systems affected and sex of the patient were analyzed. The pathological history, route, dose of administration and reason for medical prescription were also evaluated. They were classified in severity, causality and frequency.

Results: 0.03% of adverse events were reported in geriatric patients. Bleeding was the main event. The most affected organ systems were skin and genitourinary (35.2 %). Male sex predominated. Pathologic antecedents conditioned the occurrence of these events. The route, dose of administration and reason for prescription were as described in the Summary of Product Characteristics. Side effects were classified as mild, probable and frequent. Only one patient showed serious adverse effect with favorable outcome for life.

Conclusions: The use of heparin sodium 5000 IU/mL constitutes a safe product for patients of geriatric age so it does not represent a health problem.