EFECTOS ADVERSOS DERMATOLóGICOS POR ANTIBACTERIANOS.SISTEMA CUBANO DE FARMACOVIGILANCIA. 2007-2009

Introduction: Adverse reactions to antimicrobials in Cuba have taken place since 2003 to date, the first in the report of adverse reactions in general, as well as serious and fatal reactions, on the skin and schedules are the systems more affected. This research aimed to characterize the antibacterial dermatologic toxicities reported by the national coordinating pharmacovigilance unit from 2007 to 2009. Method: An observational study of Pharmacovigilance, descriptive and transversal using Spontaneous Reporting of Suspected Adverse Reaction database and the Cuban system of pharmacovigilance. Reports were analyzed for antibacterial dermatologic toxicities reported from 2007 through 2009, the primary endpoint was the dermatologic adverse effect reported. Results: A total of 3006 suspected adverse reactions to skin. Predominated in females (60.2%) and in adults, 53.7%. The antibacterial associated with increased number of notifications were 18.5% RL penicillin, amoxicillin, cephalexin, 17.3% and 9.7%. Dermatological adverse events predominated were rash and urticaria. Moderate adverse effects predominated (64.4%), 87.5% were probable and 81.8% common. Conclusions: Adverse dermatologic antibacterial dominated by females and in adults. RL Penicillin was the drug most associated with adverse reactions. Moderate adverse reactions, probable and common were the more frequent in the study.