Abstract

PEREZ RUIZ, Leslie; RAMOS CEDENO, Ana María; CORDERO JIMENEZ, Juan Rafael  and  FERNANDEZ LOPEZ, Odalis Isabel. Pharmaceutical surveillance of sertraline in Cuban patients affected by major depression episode. Rev Cubana Farm [online]. 2011, vol.45, n.1, pp.69-75. ISSN 0034-7515.

Some predominant symptoms in depression are lack of interest, fatigue, feeling of uselessness, lack of concentration, desire of being dead and insomnia. One of the drugs to treat this illness is Sertraline. For the purpose of evaluating its safety, 40 medical histories and data collection logs with information on patients included in a double-blind, controlled, randomized phase III clinical trial "Use of Sertraline in patients suffering episodes of great depression" were reviewed. These patients were seen at "Gustavo Aldereguía Lima" hospital. Demographic, clinical and adverse event data were obtained to undertake a descriptive, observational and cross-sectional study, which was classified as a study of practical consequences of drug use. The information was analyzed by SPSS, 13.0 version for Windows software. Of the 40 patients, 24 presented with adverse events for 60 %; 16 (67 %) came from the Sertraline-treated group and 8 (33 %) from the placebo group. The most frequent adverse events were loss of weight, dry mouth, headache, diarrheas and nauseas. Most of them were mild, probable causality and treatment was not required. The use of this drug was regarded as safe in treating this type of patients.

Keywords : Clinical trial; pharmaceutical surveillance; adverse event; adverse reaction; Sertraline; depression.

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