Abstract

RUIZ SALVADOR, Ana Karelia et al. Pharmacovigilance of phytomedicines and apimedicines in Cuba, 2006-2010. Rev Cubana Plant Med [online]. 2013, vol.18, n.2, pp.173-186. ISSN 1028-4796.

Introduction: plants and beehive products have been an important source of medicines for a long time, but they may also cause adverse reactions. Objective: characterize the adverse reactions associated with the use of phytomedicines and apimedicines sold in Cuba from 2006 to 2010. Method: a cross-sectional observational descriptive study was conducted. The sample consisted of all the reports on suspected adverse drug reactions caused by phytomedicines and apimedicines submitted to the National Pharmacovigilance Coordinating Unit during the study period. Results: most reports on suspected adverse reactions corresponded to the female sex (73.3 %) and the 31-60 age group (52.5 %). The phytomedicines most frequently reported were garlic tincture and syrup (13.4 %), Vimang^™ pills and syrup (9.7 %), and eucalyptus syrup and tincture (6.6 %), whereas the most frequently reported apimedicine was propolis tincture (3.4 %). The digestive system was the most commonly affected by adverse reactions, which were mostly classified as mild or probable. Conclusions: pharmacovigilance of phytomedicines and apimedicines during the study period is consistent with the bibliographic information about the topic.

Keywords : pharmacovigilance; phytomedicine; apimedicine.

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