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Resumen de Estudio de farmacovigilancia de etanercept en pacientes con patología reumatoide

Silvia Artacho Criado, E. Márquez Saavedra

  • The primordial purpose of postmarketing surveillance is to provide in a continuous manner the best possible information regarding drug safety. Objective: To evaluate the safety shown by etanercept in patients treated at our hospital during the year 2001. Method: Observational and retrospective postmarketing surveillance study. The information was compiled by means of reviewing the corresponding clinical histories. Results: Fifteen patients were evaluated and in 46% of them there were detected a total of 12 adverse reactions (ARD): two of them related to the injection, four infections (three superior respiratory tract infections and one urinary tract infection) and six reactions of another kind (two cases of hematologic alterations - neutropenia and thrombocytopenia -, one biliary lithiasis, one ocular hypertension, one case of dermal injuries in the legs and another one of vertigo). Conclusions: The produced adverse reactions were considered of slight or moderate gravity and none needed the suspension of the treatment with etanercept


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