Resumo

ALFONSO ORTA, Ismary et al. Azithromycin and cardiovascular effects reported to ther Cuban System of Drug Surveillance in the period of 2003 through 2012. Rev Cubana Farm [online]. 2014, vol.48, n.3, pp. 519-528. ISSN 1561-2988.

Introduction: azithromycin is a semisynthetic antimicrobial macrolide which is said to be associated with cardiovascular effects such as the prolongation of QT interval and disorders of the heart rate that may be fatal. The Food and Drug Administration has warned about a slight rise of mortality and risk of death in people treated for 5 days with this antibacterial drug; the International Center of Monitoring in Uppsala has also registered some cases. Objective: to characterize the adverse cardiovascular reactions to azithromycin reported to the National Coordinating Unit of Drug Surveillance from 2003 through 2012. Methods: observational, descriptive and cross-sectional study based on the national drug surveillance database and on the voluntary notifications of adverse reactions. The study universe was the patients with adverse reactions to azithromycin. The cardiovascular reactions were classified by type of reaction, severity, imputability and frequency. The patients presenting with adverse reactions were studied according to their sex and age. Results: one thousand and nine hundred sixty adverse reactions to azithromycin were reported in the study period; 96 of them were cardiovascular reactions for 4.9 % of the total amount. They were predominant in females (55.2 %) and in adults (75 %). Palpitations accounted for 44. 8% (43 patients) followed by tachycardia and chest pain. They were moderate in 67.7 % of cases, probable in 71.9 % and occasional in 60.4 %. Regarding reaction, 31.3 % of them could have been prevented and the predominant reason was the inadequate prescription of the drug in 70 % of cases. Conclusions: although no adverse cardiovascular reactions causing death have been reported in individuals treated with azithromycin, one third of them could have been prevented, therefore it is recommended to perform more proactive surveillance on this drug and all types of reactions should be duly reported to the Cuban drug surveillance system.

Palavras-chave : antimicrobials; azithromycin; drug surveillance; adverse cardiovascular reactions.

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