Abstract

JIMENEZ LOPEZ, Giset et al. Notified drugs causing severe adverse reactions in Cuba in a ten-year period. Rev Cubana Salud Pública [online]. 2014, vol.40, n.4, pp. 263-275. ISSN 0864-3466.

Introduction: drugs induce changes in morbidity and mortality of the population, but they can also cause severe adverse reactions. Cuba has a pharmacovigilance system that collects and analyses the drug adverse reactions, but the severe adverse effects recorded in a ten-year period have not been described yet. Objective: to describe the severe drug adverse effects recorded in Cuba from 2003 to 2012. Methods: a descriptive study that used the method of farmacovigilance of case series of drug adverse reactions occurred in Cuba in ten years. Results: the national database stored 116 814 reports of drug adverse reactions, 1 583 of them were severe (1.4 %), females (55.6 %) and adults aged 18 to 59 years (56.9 %) prevailed. Penicillins and hypersensitivity reactions were the most recorded, and life-threatening adverse reactions with 1 309 reports (82.7 %), those classified as probable ones with reports (59.9 %) and those of low frequency occurrence with 1 014 reports (64.1 %) predominated. Conclusions: this paper contributes to widen the knowledge on the frequency of occurrence of severe drug adverse reactions and the characteristics of the affected population throughout the country. The assessment of their impact reveals that drug adverse reactions represent a relevant health problem.

Keywords : pharmacovigilance; drug adverse reactions; adverse effects.

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