Open AccessCharacterization of adverse events during the treatment with heberprot-p® in four cuban provinces
Author(s) -
Alina Ramona Álvarez Crespo,
Liuba Alonso Carbonell,
Isis Belkis Yara Alos,
Ana Julia García Milián,
María Acelia Marrero Miragaya
Publication year - 2015
Publication title -
horizonte sanitario
Language(s) - English
Resource type - Journals
eISSN - 2007-7459
pISSN - 1665-3262
DOI - 10.19136/hs.a14n2.950
Subject(s) - adverse effect , chills , medicine , postmarketing surveillance , shivering , emergency medicine , anesthesia
Objective. The objective of this study and the reason that encouraged us to carry out this work was to characterize the adverse events reported during the treatment with Heberprot-P® in diffrent health institution/centers.
Materials and Methods: Longitudinal, multicenter, postmarketing follow-up study of Heberprot-P®. Intensive surveillance was used as PS (pharmacosurveillance) method. The following variables
were considered: presence or absence of AEs (adverse events); most frequently reported AEs; affcted organ system; serious AE according to cause conditioning both the event severity and type, and severity of ADRs (adverse drug reactions) and causality of AE reported as serious.
Results: The presence of at least one AE was reported in
260 patients (59.1%). Burning sensation and pain in injection site,
chills and shivering, were the four most frequently reported adverse
events. A total of 11 events were identifid as serious.
Conclusions :
The intensive PS of the drug should be continued since all the routine medical practice data that could be contributed are essential for the purpose of enriching the drug’s safety profie