Safety surveillance of injectable in heparin sodium 5000IU/mL solution from spontaneous notifications

Abstract

Introduction: adverse drug reactions relate to the safety of pharmaceuticals. In Cuba, in 2018 the reformulation of heparin was carried out, as part of the continuous improvement of quality, it is objective to carry out the surveillance of this drug in the usual clinical practice to evaluate its safety profile, from spontaneous notifications from June, 2018 to December 2021.

Method: an observational, descriptive and cross-sectional case series study was conducted. The universe was composed of product notifications that appear in the national database. They were grouped and analyzed in variables such as: type of reaction, affected organ systems, pathological history, group, age and sex of the patient. They were classified into severity, causality and frequency. A descriptive statistical analysis of the collected variables was performed.

Results: 31 adverse reactions were reported, among which stood out: bleeding, bruising, erythema, hives, rash, flushing, tremor, urticaria, and irritation at the injection site. The most affected organ system was the skin (51.61%). The pathological history, the geriatric group (60-86 years) and the female sex conditioned the appearance of these reactions. The largest percentages responded to reactions classified as moderate, probable, and frequent. Descriptive statistics allowed the organization into tables and graphs.

Conclusions: the study allowed to know the safety profile of this product of recent incorporation to the national market.