Abstract

ALFONSO ORTA, Ismary et al. Severe and deadly adverse reactions to antimicrobials. The Cuban drug surveillance system, 2003-2012. Rev Cubana Med Gen Integr [online]. 2013, vol.29, n.4, pp. 312-327. ISSN 0864-2125.

Introduction: adverse reactions to antimicrobials cause over 142 000 visits to emergency rooms yearly in the United States of America. They held the first place in the report, for example in 2008 when they accounted for 31.4% of all the severe adverse reactions and 25% of deadly adverse reactions. Objective: to characterize the severe and deadly adverse reactions to antimicrobials reported to the National Coordinating Unit of Drug Surveillance in the 2003-2012 period. Methods: a cross-sectional, descriptive and observational study of drug surveillance was conducted by using the national drug surveillance database in the 2003-2012 period. The total number of reports of severe and deadly adverse reactions to antimicrobials was considered. The adverse reactions were classified by type of reaction, affected organ system, attribution and frequency. The main suspected antimicrobials were identified whereas the patients who presented adverse reactions were studied by sex and age. Results: six hundred and thirty one suspected severe and deadly adverse reactions to antimicrobials were detected, 550 of them were severe and 81 deadly. Females predominated for 405 adults (60.1%). The adverse reactions compromised the general system (30.4%), the respiratory system (25.2%) and the cardiovascular one (14.9%). Anaphylactic shock was the most reported reaction and penicillin was the most associated to it. In the study, 73.5% of reactions were probable and 58.9% were occasional. Conclusions: severe and deadly adverse reactions prevailed in females and in adults. Penicillin was the most associated factor whereas the probable and occasional adverse reactions were the majority in the study.

Keywords : antimicrobials; drug surveillance; severe adverse reactions; deadly adverse reactions.

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