%0 Journal Article
%T Farmacovigilancia de la sertralina en pacientes cubanos con episodio de depresi¨®n mayor
%A P¨¦rez Ruiz
%A Leslie
%A Ramos Cede£¿o
%A Ana Mar¨ªa
%A Cordero Jim¨¦nez
%A Juan Rafael
%A Fern¨¢ndez L¨®pez
%A Odalis Isabel
%J Revista Cubana de Farmacia
%D 2011
%I ECIMED
%X 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 alderegu¨ªa 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.
%K clinical trial
%K pharmaceutical surveillance
%K adverse event
%K adverse reaction
%K sertraline
%K depression.
%U http://scielo.sld.cu/scielo.php?script=sci_abstract&pid=S0034-75152011000100008&lng=en&nrm=iso&tlng=en